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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02049138
Other study ID # M13-538
Secondary ID 2013-003530-33
Status Completed
Phase Phase 2
First received
Last updated
Start date January 24, 2014
Est. completion date July 29, 2021

Study information

Verified date June 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.


Description:

This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of upadacitinib in adults with RA who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) Phase 2 randomized controlled trial (RCT) with upadacitinib. All participants received treatment with 6 mg upadacitinib twice a day at the start of the study. Participants may have been up-titrated to 12 mg BID based on protocol-specified criteria. In Protocol Amendment 2 (January 2016) the study treatment was changed to a once daily (QD) formulation. Participants receiving 6 mg BID were transitioned to 15 mg QD and participants receiving 12 mg BID were transitioned to 30 mg QD dosing. An optional 12-week vaccine sub-study was added in Protocol Amendment 3 (November 2017) to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background methotrexate on immunological responses to pneumococcal 13-valent conjugate vaccine (PCV-13; Prevnar 13®) in RA patients. The vaccine substudy included 111 participants who were enrolled in the main study, the first participant was enrolled on 13 February 2018 and the the last participant completed the sub-study on 9 April 2020. In Protocol Amendment 5 (December 2019), the protocol was revised to allow a decrease in upadacitinib dosing from 30 mg QD to 15 mg QD, as appropriate, based on investigator's medical decision or for safety/tolerability concerns.


Recruitment information / eligibility

Status Completed
Enrollment 493
Est. completion date July 29, 2021
Est. primary completion date July 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. Subjects who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) with upadacitinib (ABT-494) and did not develop any discontinuation criteria. 2. If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive study drug. 3. If female, subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. 4. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures. Substudy: 1. Must currently be enrolled in the main study. 2. Must have been receiving a stable dose of upadacitinib (either 15 mg QD or 30 mg QD) for a minimum of 4 weeks prior to the Vaccination visit. 3. Must have been on a stable dose of background methotrexate (no change in dose or frequency) for a minimum of 4 weeks prior to the Vaccination visit. 4. If subject is on corticosteroids, must remain on a stable dose of = 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after the vaccination visit. 5. Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine. 6. Willing to receive Prevnar13® vaccine. Exclusion Criteria: 1. Pregnant or breastfeeding female. 2. Ongoing infections at Week 0 that have not been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated. 3. Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug. 4. Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria: - Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × upper limit of normal (ULN) - Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m^2 - Total white blood cell count (WBC) < 2,000/µL - Absolute neutrophil count (ANC) < 1,000/µL - Platelet count < 50,000/µL - Absolute lymphocytes count < 500/µL - Hemoglobin < 8 g/dL 5. Enrollment in another interventional clinical study while participating in this study. 6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug. Substudy: 1. Receiving any conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than methotrexate 2. Receiving > 10 mg/day of prednisone or equivalent corticosteroid therapy. 3. Receipt of any steroid injection within 4 weeks prior to Vaccination visit. 4. History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®. 5. History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit. 6. Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit. 7. Receipt of any pneumococcal vaccine. 8. Subject is not suitable for the sub-study as per the Investigator's judgment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Upadacitinib
Tablet taken orally
Biological:
Pneumococcal 13-valent conjugate vaccine (PCV-13)
Administered by intramuscular injection

Locations

Country Name City State
Belgium ReumaClinic Genk-Hasselt /ID# 137775 Genk
Belgium UCL Saint-Luc /ID# 139348 Woluwe-Saint-Lambert Bruxelles-Capitale
Bulgaria Duplicate_MHAT Kaspela /ID# 136212 Plovdiv
Bulgaria MHAT Trimontsium /ID# 135328 Plovdiv
Bulgaria UHMAT Palmed Plovdiv /ID# 135355 Plovdiv
Bulgaria Diagnostic Consultative Center /ID# 136736 Sofia
Bulgaria UMHAT Sveti Ivan Rilski /ID# 135678 Sofia
Bulgaria UMHAT Sveti Ivan Rilski /ID# 136210 Sofia
Bulgaria Diagnostic consultative center Equita /ID# 136209 Varna
Chile Corporacion de Beneficiencia Osorno /ID# 136189 Osorno Los Lagos
Chile Quantum Research /ID# 136188 Puerto Varas Los Lagos
Czechia Duplicate_Artroscan s.r.o. /ID# 139347 Ostrava
Czechia L.K.N. Arthrocentrum, s.r.o /ID# 128782 Petrkovice
Czechia Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 137776 Praha
Czechia Revmatologicky ustav v Praze /ID# 137937 Praha
Czechia Revmatologie Bruntal, s.r.o /ID# 137782 Prostejov
Hungary Orszagos Reumatologiai es Fizioterapias Intezet /ID# 128785 Budapest
Hungary Qualiclinic Kft. /ID# 134170 Budapest Pest
Hungary Szent Margit Szakrendelo /ID# 136676 Budapest
Hungary MAV Korhaz ess Rendelointezet /ID# 139971 Szolnok
Hungary Veszprem Megyei Csolnoky Ferenc Korhaz /ID# 128784 Veszprem
Israel Barzilai Medical Center /ID# 140199 Ashkelon
Israel The Chaim Sheba Medical Center /ID# 139295 Ramat Gan Tel-Aviv
Latvia M & M Centrs LTD /ID# 132439 Adazi
Latvia Arija's Ancane's Family Doctor Practice /ID# 132437 Baldone
Latvia Clinic ORTO /ID# 132438 Riga
Mexico Clinstile, S.A. de C.V. /ID# 137075 Cuauhtemoc Ciudad De Mexico
Mexico Cliditer SA de CV /ID# 136876 Mexico City
Mexico Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 137307 Mexico City
New Zealand Waikato Hospital /ID# 131908 Hamilton Waikato
New Zealand Porter Rheumatology Ltd /ID# 133983 Nelson
New Zealand Timaru Medical Specialists Ltd /ID# 131909 Timaru Canterbury
Poland Gabinet Internistyczno-Reumatologiczny /ID# 135876 Bialystok Podlaskie
Poland Ambulatorium Sp. z o.o /ID# 138074 Elblag Warminsko-mazurskie
Poland Centrum Medyczne Pratia Gdynia /ID# 137362 Gdynia Pomorskie
Poland Pratia MCM Krakow /ID# 134749 Krakow Malopolskie
Poland Duplicate_REUMED Filia nr 2 /ID# 128839 Lublin
Poland NZOZ Lecznica MAK-MED s.c. /ID# 128838 Nadarzyn Mazowieckie
Poland Twoja Przychodnia Centrum Medyczne /ID# 128840 Nowa Sol Lubuskie
Poland Medicome sp. z o.o. /ID# 137397 Oswiecim Mazowieckie
Poland Prywatna Praktyka Lekarska /ID# 128837 Poznan Wielkopolskie
Poland Centrum Medyczne Amed Warszawa Zoliborz /ID# 128835 Warsaw Mazowieckie
Poland Centrum Medyczne Pratia Warszawa /ID# 136650 Warsaw Mazowieckie
Poland Centrum Medyczne Reuma Park w Warszawie /ID# 140198 Warsaw Mazowieckie
Poland NBR Polska /ID# 136208 Warszawa Mazowieckie
Poland Reum-Medica S.C. /ID# 128841 Wroclaw Dolnoslaskie
Puerto Rico Dr. Ramon L. Ortega-Colon, MD /ID# 128760 Carolina
Puerto Rico GCM Medical Group PSC - Hato Rey /ID# 128759 San Juan
Puerto Rico Mindful Medical Research /ID# 136211 San Juan
Russian Federation Kazan State Medical University /ID# 136734 Kazan Tatarstan, Respublika
Russian Federation St. Petersburg Research Institute of Emergency Medicine n.?. I. I. Dzhanelidze /ID# 136652 Sankt-Peterburg
Russian Federation Tver Regional Clinical Hospital /ID# 137576 Tver Tverskaya Oblast
Slovakia MEDMAN s.r.o. /ID# 136649 Martin
Slovakia Poliklinika Senica n.o. /ID# 134728 Senica
South Africa Dr MJ Prins /ID# 138540 Cape Town Western Cape
South Africa Winelands Medical Research Centre /ID# 134669 Stellenbosch Western Cape
Spain Hospital Universitario A Coruna - CHUAC /ID# 128846 A Coruna
Spain Hospital CIMA Sanitas /ID# 128849 Barcelona
Spain Hospital General Universitario de Elche /ID# 128851 Elche Alicante
Spain Hospital Clinico Universitario San Carlos /ID# 128852 Madrid
Spain Hospital Regional de Malaga /ID# 128847 Málaga Malaga
Spain Hospital Infanta Sofia /ID# 136653 San Sebastián de Los Reyes Madrid
Spain Clinica Gaias /ID# 133868 Santiago de Compostela A Coruna
Spain Hospital QuironSalud Infanta Luisa /ID# 135689 Sevilla
Spain Hospital Universitario Virgen de Valme /ID# 134668 Sevilla
Spain Hospital Universitario Virgen Macarena /ID# 128853 Sevilla
Ukraine NSC Strazhesko Ist Cardiology /ID# 137330 Kiev
Ukraine Municipal Non-profit Institution Kyiv City Clinical Hospital No. 3 of the Exec /ID# 137334 Kyiv
United Kingdom West Suffolk Hospital /ID# 128858 Bury St Edmunds Suffolk
United Kingdom Duplicate_Leeds Teaching Hospitals NHS Trust /ID# 141308 Leeds
United Kingdom Barts Health NHS Trust /ID# 135683 London London, City Of
United Kingdom Warrington and Halton Hospitals NHS Foundation Trust /ID# 137514 Warrington Cheshire West And Chester
United States Austin Rheumatology Research /ID# 124083 Austin Texas
United States Arthritis & Rheumatic Disease Specialties /ID# 135910 Aventura Florida
United States Accurate Clinical Management /ID# 128751 Baytown Texas
United States Duplicate_East Penn Rheumatology Assoc /ID# 135920 Bethlehem Pennsylvania
United States Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082 Boca Raton Florida
United States New England Research Associates, LLC /ID# 124085 Bridgeport Connecticut
United States DJL Clinical Research, PLLC /ID# 131936 Charlotte North Carolina
United States Cincinnati Rheumatic Disease Study Group, Inc. /ID# 135921 Cincinnati Ohio
United States Mountain State Clinical Research /ID# 124088 Clarksburg West Virginia
United States Summit Medical Group /ID# 124076 Clifton New Jersey
United States Omega Research Maitland, LLC /ID# 124094 DeBary Florida
United States Denver Arthritis Clinic /ID# 135901 Denver Colorado
United States Altoona Ctr Clinical Res /ID# 124089 Duncansville Pennsylvania
United States Aurora Rheumatology and Immunotherapy Center /ID# 135922 Franklin Wisconsin
United States Arthritis and Osteoporosis Associates /ID# 135907 Freehold New Jersey
United States Klein and Associates MD - Hagerstown /ID# 124086 Hagerstown Maryland
United States C.V. Mehta MD, Med Corporation /ID# 124092 Hemet California
United States Accurate Clinical Management /ID# 128752 Houston Texas
United States Accurate Clinical Research /ID# 128753 Houston Texas
United States Accurate Clinical Research /ID# 128754 Houston Texas
United States Baylor College of Medicine - Baylor Medical Center /ID# 135905 Houston Texas
United States Houston Institute for Clin Res /ID# 135912 Houston Texas
United States Rheum Assoc of North Alabama /ID# 135926 Huntsville Alabama
United States University of Florida /ID# 124087 Jacksonville Florida
United States Moores Cancer Center at UC San Diego /ID# 128747 La Jolla California
United States June DO, PC /ID# 124081 Lansing Michigan
United States Arthritis and Osteo Assoc /ID# 132280 Las Cruces New Mexico
United States North Georgia Rheumatology Group /ID# 128746 Lawrenceville Georgia
United States Dr. Ramesh Gupta /ID# 128744 Memphis Tennessee
United States SW Rheumatology Res. LLC /ID# 135927 Mesquite Texas
United States Suncoast Research Group /ID# 137774 Miami Florida
United States Health Research of Oklahoma /ID# 135904 Oklahoma City Oklahoma
United States Omega Research Maitland, LLC /ID# 137398 Orlando Florida
United States Millennium Research /ID# 135917 Ormond Beach Florida
United States Kansas City Internal Medicine /ID# 135916 Overland Park Kansas
United States Desert Medical Advances - Palm Desert /ID# 135911 Palm Desert California
United States Arthritis Center, Inc. /ID# 124090 Palm Harbor Florida
United States AZ Arthritis and Rheumotology Research, PLLC /ID# 135902 Phoenix Arizona
United States AZ Arthritis and Rheumotology Research, PLLC /ID# 135931 Phoenix Arizona
United States IRIS Research and Development, LLC /ID# 140362 Plantation Florida
United States Orrin Troum, M.D. and Medical /ID# 135933 Santa Monica California
United States Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 124080 Summerville South Carolina
United States Duplicate_Robin K. Dore MD, Inc /ID# 135906 Tustin California
United States Inland Rheum Clin Trials Inc. /ID# 136716 Upland California
United States STAT Research, Inc. /ID# 134906 Vandalia Ohio
United States Lovelace Scientific Resources /ID# 128745 Venice Florida
United States Duplicate_Desert Valley Medical Group /ID# 135932 Victorville California
United States Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 135913 Voorhees New Jersey
United States The Center for Rheumatology and Bone Research /ID# 124077 Wheaton Maryland
United States PRN Professional Research Network of Kansas, LLC /ID# 124091 Wichita Kansas
United States Clinical Pharmacology Study Group /ID# 124079 Worcester Massachusetts
United States Emkey Arthritis and Osteoporosis Clinic /ID# 135908 Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Chile,  Czechia,  Hungary,  Israel,  Latvia,  Mexico,  New Zealand,  Poland,  Puerto Rico,  Russian Federation,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
= 20% improvement in 68-tender joint count;
= 20% improvement in 66-swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Primary Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
= 50% improvement in 68-tender joint count;
= 50% improvement in 66-swollen joint count; and
= 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Primary Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
= 70% improvement in 68-tender joint count;
= 70% improvement in 66-swollen joint count; and
= 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Primary Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination
Secondary Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity.
LDA is defined as a DAS28(CRP) score = 3.2.
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity.
Clinical remission is defined as a DAS28(CRP) score < 2.6.
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA is defined as a CDAI score = 10.
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Clinical remission is defined as a CDAI score = 2.8.
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity.
LDA is defined as a SDAI score = 11.0.
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity.
Clinical remission is defined as a SDAI score = 3.3.
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Tender Joint Count (TJC68) Over Time Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst). Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Swollen Joint Count (SJC66) Over Time Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst). Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Physician's Global Assessment of Disease Activity Over Time The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Patient's Global Assessment of Disease Activity Over Time The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity. Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Patient's Assessment of Pain Over Time Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain." Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement. Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23.
A score < 10 means low risk, scores between 10 and 17 indicate medium risk, and scores > 17 indicate high risk of work instability.
A negative change from Baseline indicates improvement in work instability.
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems).
A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status.
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Change From Baseline in EuroQoL-5D VAS Score Over Time The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
A positive change from baseline indicates improvement.
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Secondary Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). Vaccination Baseline and 12 weeks after vaccination
Secondary Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination Vaccination Baseline and 4 and 12 weeks after vaccination
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