Rheumatoid Arthritis Clinical Trial
NCT number | NCT00650767 |
Other study ID # | ARRAY-162-201 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2008 |
Est. completion date | July 2009 |
Verified date | November 2020 |
Source | Array BioPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.
Status | Completed |
Enrollment | 201 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug. - Patient has received a stable dose of methotrexate for = 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study. - Patient has received a stable dose of folate for = 6 weeks and is willing to continue on this regimen for the duration of the study. - No prior use of biological agents for the treatment of rheumatoid arthritis. - Additional criteria exist. Key Exclusion Criteria: - Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures. - A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis. - Additional criteria exist. |
Country | Name | City | State |
---|---|---|---|
Argentina | Asistencia Integral en Reumatologia | Buenos Aires | |
Argentina | CEMIC | Buenos Aires | |
Argentina | Hospital Britanico | Buenos Aires | |
Argentina | CER San Juan | San Juan | |
Argentina | Centro Medico Privado de Reumatologia | San Miguel de Tucumán | |
Argentina | Centro de Investigaciones Clinicas del Litoral SRL | Santa Fe | |
Brazil | CETI - Hospital das Clínicas da Universidade Federal do Paraná | Curitiba | PR |
Brazil | Médicos Unidos Ltda. | Goiânia | GO |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Brazil | Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande do Sul | Porto Alegre | RS |
Brazil | Hospital Heliópolis | São Paulo | SP |
Brazil | Hospital São Paulo / Instituto Paulista de Reumatologia | São Paulo | SP |
Brazil | Instituto de Medicina Avançada (IMA Brasil) | São Paulo | SP |
Hungary | Budai Irgalmasrendi Kórház - Allergólógia és Immunológia | Budapest | |
Hungary | Synexus Ltd Hungary | Budapest | |
Hungary | Békés Megyei Pándy Kálmán Kórház - Rheumatology | Gyula | |
Hungary | Mozgasszervi Rehabilitacios Kozpont | Mezokövesd | |
Hungary | Fejér Megyei Szent György Kórház - Rheumatology | Székesfehérvár | |
Hungary | MÁV Kórház - Clinical Pharmacology | Szolnok | |
Hungary | Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és Gyógyfürdo Kórház, Egyetemi Oktató Kórház, Zártköruen Muködo Nonprofit Részvénytársaság - Rheumatology | Szombathely | |
Peru | Instituto de Investigacion y Seguridad Medica EIRL | Arequipa | |
Peru | Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia | Lima | |
Peru | Clinica San Felipe - Centro de Estudios Clinicos CGYM | Lima | |
Peru | Hospital Maria Auxiliadora - Centro de Investigaciones Medicas | Lima | |
Poland | Centrum Osteoporozy i Chorób Kostno-Stawowych | Bialystok | |
Poland | Wojewódzki Szpital Zespolony - Oddzial Reumatologiczny | Elblag | |
Poland | Centrum Leczenia Chorob Cywilizacyjnych | Gdynia | |
Poland | NZOZ Reumed | Lublin | |
Poland | Centrum Leczenia Chorob Cywilizacyjnych | Warszawa | |
Poland | Synexus SCM Sp. z o.o. | Wroclaw | |
Romania | Spitalul Clinic "Sf, Maria" | Bucuresti | |
Romania | Spitalul Clinic Judetean de Urgenta | Cluj-Napoca | |
Romania | Spitalul Clinic Judetean de Urgenta | Targu Mures | |
Romania | Cabinet Medical "Prof. Dr. Miorara Banciu" | Timisoara | |
United States | Spartanburg Medical Research | Spartanburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Array Biopharma, now a wholly owned subsidiary of Pfizer |
United States, Argentina, Brazil, Hungary, Peru, Poland, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | American College of Rheumatology 20% (ACR20) Response Rate at Week 12 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 12 | |
Secondary | American College of Rheumatology 20% (ACR20) Response Rate at Week 1 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 1 | |
Secondary | American College of Rheumatology 20% (ACR20) Response Rate at Week 2 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 2 | |
Secondary | American College of Rheumatology 20% (ACR20) Response Rate at Week 4 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 4 | |
Secondary | American College of Rheumatology 20% (ACR20) Response Rate at Week 8 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 8 | |
Secondary | American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 16 (Follow-up) | |
Secondary | American College of Rheumatology 50% (ACR50) Response Rate at Week 1 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 1 | |
Secondary | American College of Rheumatology 50% (ACR50) Response Rate at Week 2 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 2 | |
Secondary | American College of Rheumatology 50% (ACR50) Response Rate at Week 4 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 4 | |
Secondary | American College of Rheumatology 50% (ACR50) Response Rate at Week 8 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 8 | |
Secondary | American College of Rheumatology 50% (ACR50) Response Rate at Week 12 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 12 | |
Secondary | American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 16 (Follow-up) | |
Secondary | American College of Rheumatology 70% (ACR70) Response Rate at Week 1 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 1 | |
Secondary | American College of Rheumatology 70% (ACR70) Response Rate at Week 2 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 2 | |
Secondary | American College of Rheumatology 70% (ACR70) Response Rate at Week 4 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 4 | |
Secondary | American College of Rheumatology 70% (ACR70) Response Rate at Week 8 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 8 | |
Secondary | American College of Rheumatology 70% (ACR70) Response Rate at Week 12 | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 12 | |
Secondary | American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 16 (Follow-up) | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Baseline | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 1 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 2 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 4 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 8 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 12 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 16 (Follow-up) | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Baseline | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 1 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 2 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 4 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 8 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 12 | |
Secondary | American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 16 (Follow-up) | |
Secondary | Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain. | Baseline | |
Secondary | Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain. | Week 1 | |
Secondary | Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain. | Week 2 | |
Secondary | Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain. | Week 4 | |
Secondary | Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain. | Week 8 | |
Secondary | Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain. | Week 12 | |
Secondary | Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain. | Week 16 (Follow-up) | |
Secondary | Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Baseline | |
Secondary | Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 1 | |
Secondary | Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 2 | |
Secondary | Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 4 | |
Secondary | Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 8 | |
Secondary | Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 12 | |
Secondary | Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 16 (Follow-up) | |
Secondary | Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Baseline | |
Secondary | Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 1 | |
Secondary | Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 2 | |
Secondary | Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 4 | |
Secondary | Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 8 | |
Secondary | Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 12 | |
Secondary | Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 16 (Follow-up) | |
Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Baseline | |
Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 1 | |
Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 2 | |
Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 4 | |
Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 8 | |
Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 12 | |
Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 16 (Follow-up) | |
Secondary | C-Reactive Protein (CRP) at Baseline | Baseline | ||
Secondary | C-Reactive Protein (CRP) at Week 1 | Week 1 | ||
Secondary | C-Reactive Protein (CRP) at Week 2 | Week 2 | ||
Secondary | C-Reactive Protein (CRP) at Week 4 | Week 4 | ||
Secondary | C-Reactive Protein (CRP) at Week 8 | Week 8 | ||
Secondary | C-Reactive Protein (CRP) at Week 12 | Week 12 | ||
Secondary | C-Reactive Protein (CRP) at Week 16 (Follow-up) | Week 16 (Follow-up) | ||
Secondary | Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. | Baseline | |
Secondary | Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. | Week 1 | |
Secondary | Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. | Week 2 | |
Secondary | Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. | Week 4 | |
Secondary | Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. | Week 8 | |
Secondary | Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. | Week 12 | |
Secondary | Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. | Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best). | Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 16 (Follow-up) | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Baseline | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 4 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 8 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 12 | |
Secondary | SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group. | Week 16 (Follow-up) |
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