A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650767
• Other study ID #: ARRAY-162-201
• Status: Completed
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: November 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
• Placebo; oral
matching placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Hungary,  Peru,  Poland,  Romania, 

Outcome

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)