Back to resultsA Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Methotrexate
Upadacitinib
Placebo Upadacitinib
Placebo Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents, Upadacitinib, ABT-494
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of RA for >= 3 months.
- Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable dose for >= 4 weeks prior to first dose of study drug.
- Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
- Meets the following minimum disease activity criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
- Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Sites / Locations
- Rheum Assoc of North Alabama /ID# 146009
- Alabama Medical Group, PC /ID# 153941
- ArthroCare Arthritis Care & Re /ID# 143751
- Elite Clinical Studies, LLC /ID# 143760
- University of Arizona Cancer Center - North Campus /ID# 147175
- NEA Baptist Womens Clinic /ID# 148904
- C.V. Mehta MD, Med Corporation /ID# 143762
- Arthritis Assoc & Osteo Ctr /ID# 147176
- Ctr Rheum, Immuno, Arthritis /ID# 143766
- South Florida Research Ph I-IV /ID# 151983
- Advent Clinical Research /ID# 143767
- Sarasota Arthritis Center /ID# 146011
- W. Broward Rheum Assoc Inc. /ID# 146010
- Clinical Research West FL /ID# 148726
- SW FL Clin Res Ctr, Tampa, FL /ID# 143763
- University of South Florida /ID# 146004
- BayCare Medical Group, Inc. /ID# 151985
- BayCare Medical Group, Inc. /ID# 163595
- Jefrey D. Lieberman, MD, P.C. /ID# 151816
- Great Lakes Clinical Trials /ID# 150935
- PRN Professional Research Network of Kansas, LLC /ID# 143761
- Ochsner Clinic Foundation /ID# 153573
- The Arthritis & Diabetes Clinic, Inc. /ID# 160809
- Vanguard Medical Research, LLC /ID# 153124
- Mansfield Health Center /ID# 161627
- Quality Clinical Research Inc. /ID# 156415
- Dartmouth-Hitchcock Medical Center /ID# 146008
- Albuquerque Clinical Trials, Inc /ID# 147618
- Arthritis and Osteo Assoc /ID# 147177
- Coastal Carolina Health Care /ID# 149275
- STAT Research, Inc. /ID# 143770
- Health Research Oklahoma /ID# 159550
- Healthcare Research Consultant /ID# 147632
- Innovative Clinical Research /ID# 143757
- Nashville Arthritis and Rheumatology /ID# 162641
- Tekton Research, Inc. /ID# 159554
- Diagnostic Group Integrated He /ID# 148725
- Trinity Universal Res Assoc /ID# 150138
- Arth and Osteo Clin Brazo Valley /ID# 160810
- Adriana Pop-Moody MD Clinic PA /ID# 147627
- Accurate Clinical Management /ID# 143768
- Accurate Clinical Research /ID# 143769
- Pioneer Research Solutions, Inc. /ID# 143765
- P&I Clinical Research /ID# 151358
- SW Rheumatology Res. LLC /ID# 147620
- Sun Research Institute /ID# 159553
- Arthritis Clinic of Central TX /ID# 149266
- Adv Rheumatology of Houston /ID# 162609
- DM Clinical Research /ID# 151359
- Arthritis & Osteoporosis Clinic /ID# 143752
- Ctr for Arth and Rheum Disease /ID# 143759
- Aurora Rheumatology and Immunotherapy Center /ID# 160811
- Mautalen Salud e Investigacion /ID# 145980
- Ctr Privado Med Familiar /ID# 149183
- Consultorio Reumatologic Pampa /ID# 145979
- Centro de Educación Médica e Investigaciones Clínicas "Norberto Quimo" - CEMIC /ID# 149176
- Cordis S.A. /Id# 152621
- Centro de Enfermedades /ID# 153543
- Royal Prince Alfred Hospital /ID# 146028
- Rheuma-Zentrum Wien-Oberlaa /ID# 144728
- Algemeen Stedelijk Ziekenhuis /ID# 148720
- ReumaClinic Genk /ID# 146030
- Diag Consult Ctr 17 Sofia EOOD /ID# 144730
- UMHAT Sv. Ivan Rilski /ID# 147351
- Reg. Clinical Hosptial Concepcion /ID# 151267
- Quantum Research LTDA. /ID# 145984
- Quantum Research Stgo. /ID# 145983
- CTCenter MaVe, s.r.o. /ID# 144823
- Nuselská poliklinika, Revmatologie /ID# 145986
- Thomayerova nemocnice /ID# 144736
- RHEUMA s.r.o. /ID# 144737
- Medical Plus, s.r.o. /ID# 144821
- MediTrials /ID# 159745
- North Estonian Medical Centre /ID# 145455
- General Hospital of Athens "Ippokratio" /ID# 144739
- Vital Medical Center Orvosi es /ID# 144740
- Magyar Honvedseg Egeszsegugyi Kozpont /ID# 144743
- Pest Megyei Flor Ferenc Korhaz /ID# 144742
- Fejer Megyei Szent Gyorgy Korh /ID# 144741
- Barzilai Medical Center /ID# 144744
- Bnai Zion Medical Center /ID# 144745
- The Lady Davis Carmel MC /ID# 147174
- Sheba Medical Center /ID# 144824
- Universita di Catanzaro Magna Graecia /ID# 144747
- A.O.U.I. di Verona Policlinico /ID# 144746
- Kondo Clinic for Rheum & Ortho /ID# 148268
- NHO Kyushu Medical Center /ID# 148279
- NHO Kyushu Medical Center /ID# 148280
- Aso Iizuka Hospital /ID# 148272
- Inoue Hospital /ID# 148069
- Bay Side Misato Medical Center /ID# 148281
- Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148269
- Kumamoto Shinto General Hospital /ID# 148286
- Nagasaki University Hospital /ID# 149859
- Sasebo Chuo Hospital /ID# 148275
- Osaka Red Cross Hospital /ID# 148267
- Seirei Hamamatsu General Hosp /ID# 148270
- Ohira Orthopaedic Hospital /ID# 157944
- Shirahama Hamayu Hospital /ID# 148277
- Sanuki Municipal Hospital /ID# 158080
- Hokkaido University Hospital /ID# 148285
- Hokkaido Medical Center for Rheumatic Diseases /ID# 148274
- Miyasato Clinic /ID# 148271
- Takaoka Rheumatic Orthopedic Clinic /ID# 148068
- Matsuta Clinic /ID# 148278
- National Hospital Organization Shimoshizu National Hospital /ID# 148273
- Desarrollos Biomedicos y Biotc /ID# 147379
- Cryptex Investigación Clínica S.A de C.V /ID# 147095
- WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 157622
- REUMED Sp.z o.o. Filia nr 1 /ID# 144752
- Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149521
- Osteo-Medic spolka cywilna /ID# 144753
- Centrum Badań Klinicznych Pi-House /ID# 149520
- NZOZ Centrum Reumatologiczne /ID# 144749
- Medyczne Centrum Hetmanska /ID# 144751
- Instituto Portugues De Reumatologia /ID# 149281
- Centro Hospitalar De Vila Nova /ID# 146036
- Centro Hospitalar Lisboa Norte, EPE /ID# 146035
- Centro Hospitalar Baixo Vouga /ID# 152916
- Dr. Ramon L. Ortega-Colon, MD /ID# 145989
- Ponce School of Medicine /ID# 145990
- Spitalul Municipal Ploiesti /ID# 144756
- Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 147255
- LLC Medical Center /ID# 144758
- Perm Clinical Center of FMBA /ID# 145993
- Tver Regional Clinical Hosp. /ID# 147254
- Сity Clinical Hospital 4 /ID# 145994
- City Clinical Hospital Botkina /ID# 145995
- City Clinical Hospital #5 /ID# 149832
- Orenburg State Medical Academy /ID# 145992
- Republican Clin Hos n.a. Baran /ID# 147251
- Samara Regional Clinical Hosp /ID# 150934
- Reg Clin Hosp n.a. Kuvatova G. /ID# 144757
- Yaroslavi State Medical Univer /ID# 147253
- Institute for Rheumatology /ID# 144759
- Institute for Rheumatology /ID# 144761
- Institute for Rheumatology /ID# 144762
- Special Hospital for Rheuma /ID# 144760
- Wits Clinical Research Site /ID# 149835
- University of Pretoria /ID# 148740
- Synexus Helderberg Clinical Tr /ID# 148724
- Tiervlei Trial Centre /ID# 153086
- Hospital Plató /ID# 145999
- Hospital Univ Germans Trias I /ID# 146037
- Hospital Infanta Luisa /ID# 144771
- Hospital Universitario de Valm /ID# 144770
- Hospital Universitario La Fe /ID# 158013
- Uludağ Üniversitesi Atatürk Rehabilitasyon Uygulama ve Araştırma Merkezi /ID# 144772
- Lviv Regional Clinical Hospita /ID# 154448
- Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 146002
- Regional Clinical Hospital /ID# 152007
- NSC-Strazhesko Ist Cardiology /ID# 152004
- Zaporizhzhia Regional Clinical /ID# 146000
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Upadacitinib 30 mg
Upadacitinib 15 mg
Methotrexate / Upadacitinib 30 mg
Methotrexate / Upadacitinib 15 mg
Arm Description
Period 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Period 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Outcomes
Primary Outcome Measures
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. 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).
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 14.
The DAS28 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than or equal to 3.2 indicates low disease activity.
Secondary Outcome Measures
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14
The DAS28 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 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.
Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14
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. A negative change from Baseline in the overall score indicates improvement.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14
The DAS28 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Change From Baseline in Duration of Morning Stiffness at Week 14
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14
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).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02706951
Brief Title
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Official Title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
August 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX.
The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
Detailed Description
The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit.
Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of four treatment groups:
Group 1: upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2)
Group 2: upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2)
Group 3: MTX (Period 1) → upadacitinib 30 mg QD (Period 2)
Group 4: MTX (Period 1) → upadacitinib 15 mg QD (Period 2)
Starting with implementation of Protocol Amendment 5, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents, Upadacitinib, ABT-494
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
648 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks.
Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Arm Title
Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks.
Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Arm Title
Methotrexate / Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks.
Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Arm Title
Methotrexate / Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks.
Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Capsule; Oral
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, Rinvoq
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Placebo Upadacitinib
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Placebo Methotrexate
Intervention Description
Capsule; Oral
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14
Description
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. 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).
Time Frame
Baseline and week 14
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14
Description
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 14.
The DAS28 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than or equal to 3.2 indicates low disease activity.
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14
Description
The DAS28 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 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.
Time Frame
Baseline to week 14
Title
Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14
Description
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. A negative change from Baseline in the overall score indicates improvement.
Time Frame
Baseline to week 14
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14
Description
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Time Frame
Baseline to week 14
Title
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14
Description
The DAS28 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Time Frame
Week 14
Title
Change From Baseline in Duration of Morning Stiffness at Week 14
Description
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.
Time Frame
Baseline to week 14
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14
Description
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).
Time Frame
Baseline and week 14
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 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).
Time Frame
Baseline and week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA for >= 3 months.
Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable dose for >= 4 weeks prior to first dose of study drug.
Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
Meets the following minimum disease activity criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
Exclusion Criteria:
Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Rheum Assoc of North Alabama /ID# 146009
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alabama Medical Group, PC /ID# 153941
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-1787
Country
United States
Facility Name
ArthroCare Arthritis Care & Re /ID# 143751
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Elite Clinical Studies, LLC /ID# 143760
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
University of Arizona Cancer Center - North Campus /ID# 147175
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719-1478
Country
United States
Facility Name
NEA Baptist Womens Clinic /ID# 148904
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
C.V. Mehta MD, Med Corporation /ID# 143762
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Arthritis Assoc & Osteo Ctr /ID# 147176
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Ctr Rheum, Immuno, Arthritis /ID# 143766
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
South Florida Research Ph I-IV /ID# 151983
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166-7225
Country
United States
Facility Name
Advent Clinical Research /ID# 143767
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Sarasota Arthritis Center /ID# 146011
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
W. Broward Rheum Assoc Inc. /ID# 146010
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Clinical Research West FL /ID# 148726
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
SW FL Clin Res Ctr, Tampa, FL /ID# 143763
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
University of South Florida /ID# 146004
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
BayCare Medical Group, Inc. /ID# 151985
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Facility Name
BayCare Medical Group, Inc. /ID# 163595
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Facility Name
Jefrey D. Lieberman, MD, P.C. /ID# 151816
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Great Lakes Clinical Trials /ID# 150935
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
PRN Professional Research Network of Kansas, LLC /ID# 143761
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Ochsner Clinic Foundation /ID# 153573
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836-6455
Country
United States
Facility Name
The Arthritis & Diabetes Clinic, Inc. /ID# 160809
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Vanguard Medical Research, LLC /ID# 153124
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71011
Country
United States
Facility Name
Mansfield Health Center /ID# 161627
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
Quality Clinical Research Inc. /ID# 156415
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 146008
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc /ID# 147618
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Arthritis and Osteo Assoc /ID# 147177
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Coastal Carolina Health Care /ID# 149275
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
STAT Research, Inc. /ID# 143770
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377-9464
Country
United States
Facility Name
Health Research Oklahoma /ID# 159550
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2400
Country
United States
Facility Name
Healthcare Research Consultant /ID# 147632
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Innovative Clinical Research /ID# 143757
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Nashville Arthritis and Rheumatology /ID# 162641
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tekton Research, Inc. /ID# 159554
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Diagnostic Group Integrated He /ID# 148725
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Trinity Universal Res Assoc /ID# 150138
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Arth and Osteo Clin Brazo Valley /ID# 160810
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Adriana Pop-Moody MD Clinic PA /ID# 147627
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Accurate Clinical Management /ID# 143768
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research /ID# 143769
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Pioneer Research Solutions, Inc. /ID# 143765
City
Houston
State/Province
Texas
ZIP/Postal Code
77098-5294
Country
United States
Facility Name
P&I Clinical Research /ID# 151358
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904-3132
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 147620
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Sun Research Institute /ID# 159553
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Arthritis Clinic of Central TX /ID# 149266
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Adv Rheumatology of Houston /ID# 162609
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
DM Clinical Research /ID# 151359
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic /ID# 143752
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Ctr for Arth and Rheum Disease /ID# 143759
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Aurora Rheumatology and Immunotherapy Center /ID# 160811
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Mautalen Salud e Investigacion /ID# 145980
City
Buenos Aires
ZIP/Postal Code
1128
Country
Argentina
Facility Name
Ctr Privado Med Familiar /ID# 149183
City
Buenos Aires
ZIP/Postal Code
1417
Country
Argentina
Facility Name
Consultorio Reumatologic Pampa /ID# 145979
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quimo" - CEMIC /ID# 149176
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Cordis S.A. /Id# 152621
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Centro de Enfermedades /ID# 153543
City
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Royal Prince Alfred Hospital /ID# 146028
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Rheuma-Zentrum Wien-Oberlaa /ID# 144728
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Algemeen Stedelijk Ziekenhuis /ID# 148720
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ReumaClinic Genk /ID# 146030
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Diag Consult Ctr 17 Sofia EOOD /ID# 144730
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski /ID# 147351
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Reg. Clinical Hosptial Concepcion /ID# 151267
City
Concepcion
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Quantum Research LTDA. /ID# 145984
City
Puerto Varas
ZIP/Postal Code
5550170
Country
Chile
Facility Name
Quantum Research Stgo. /ID# 145983
City
Santiago
ZIP/Postal Code
7500588
Country
Chile
Facility Name
CTCenter MaVe, s.r.o. /ID# 144823
City
Olomouc
State/Province
Olomoucky Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Nuselská poliklinika, Revmatologie /ID# 145986
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Thomayerova nemocnice /ID# 144736
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
RHEUMA s.r.o. /ID# 144737
City
Breclav
ZIP/Postal Code
690 02
Country
Czechia
Facility Name
Medical Plus, s.r.o. /ID# 144821
City
Uherské Hradište
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
MediTrials /ID# 159745
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
North Estonian Medical Centre /ID# 145455
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
General Hospital of Athens "Ippokratio" /ID# 144739
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Vital Medical Center Orvosi es /ID# 144740
City
Veszprém
State/Province
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 144743
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz /ID# 144742
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korh /ID# 144741
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Barzilai Medical Center /ID# 144744
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Bnai Zion Medical Center /ID# 144745
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
The Lady Davis Carmel MC /ID# 147174
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Sheba Medical Center /ID# 144824
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Universita di Catanzaro Magna Graecia /ID# 144747
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
A.O.U.I. di Verona Policlinico /ID# 144746
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Kondo Clinic for Rheum & Ortho /ID# 148268
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
NHO Kyushu Medical Center /ID# 148279
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
NHO Kyushu Medical Center /ID# 148280
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Aso Iizuka Hospital /ID# 148272
City
Iizuka-shi
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Inoue Hospital /ID# 148069
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
3700053
Country
Japan
Facility Name
Bay Side Misato Medical Center /ID# 148281
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
781-0112
Country
Japan
Facility Name
Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148269
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-0920
Country
Japan
Facility Name
Kumamoto Shinto General Hospital /ID# 148286
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
8628655
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 149859
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Sasebo Chuo Hospital /ID# 148275
City
Sasebo-city
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Osaka Red Cross Hospital /ID# 148267
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Seirei Hamamatsu General Hosp /ID# 148270
City
Hamamatsu
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
Ohira Orthopaedic Hospital /ID# 157944
City
Hyuga
ZIP/Postal Code
883-0043
Country
Japan
Facility Name
Shirahama Hamayu Hospital /ID# 148277
City
Nishimura
ZIP/Postal Code
649-2211
Country
Japan
Facility Name
Sanuki Municipal Hospital /ID# 158080
City
Sanuki
ZIP/Postal Code
769-2321
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 148285
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hokkaido Medical Center for Rheumatic Diseases /ID# 148274
City
Sapporo
ZIP/Postal Code
063-0811
Country
Japan
Facility Name
Miyasato Clinic /ID# 148271
City
Shunan
ZIP/Postal Code
745-0824
Country
Japan
Facility Name
Takaoka Rheumatic Orthopedic Clinic /ID# 148068
City
Takaoka
ZIP/Postal Code
933-0874
Country
Japan
Facility Name
Matsuta Clinic /ID# 148278
City
Tokyo
ZIP/Postal Code
155-0032
Country
Japan
Facility Name
National Hospital Organization Shimoshizu National Hospital /ID# 148273
City
Yotsukaido
ZIP/Postal Code
284-0003
Country
Japan
Facility Name
Desarrollos Biomedicos y Biotc /ID# 147379
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Cryptex Investigación Clínica S.A de C.V /ID# 147095
City
Mexico City
ZIP/Postal Code
06100
Country
Mexico
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 157622
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
51-685
Country
Poland
Facility Name
REUMED Sp.z o.o. Filia nr 1 /ID# 144752
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149521
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Osteo-Medic spolka cywilna /ID# 144753
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Centrum Badań Klinicznych Pi-House /ID# 149520
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
NZOZ Centrum Reumatologiczne /ID# 144749
City
Elblag
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Medyczne Centrum Hetmanska /ID# 144751
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Instituto Portugues De Reumatologia /ID# 149281
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar De Vila Nova /ID# 146036
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, EPE /ID# 146035
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Baixo Vouga /ID# 152916
City
Porto
ZIP/Postal Code
4050-111
Country
Portugal
Facility Name
Dr. Ramon L. Ortega-Colon, MD /ID# 145989
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Ponce School of Medicine /ID# 145990
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Spitalul Municipal Ploiesti /ID# 144756
City
Ploiesti
ZIP/Postal Code
100337
Country
Romania
Facility Name
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 147255
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
LLC Medical Center /ID# 144758
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Perm Clinical Center of FMBA /ID# 145993
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
Tver Regional Clinical Hosp. /ID# 147254
City
Tver
State/Province
Tverskaya Oblast
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Сity Clinical Hospital 4 /ID# 145994
City
Ivanovo
ZIP/Postal Code
153005
Country
Russian Federation
Facility Name
City Clinical Hospital Botkina /ID# 145995
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
City Clinical Hospital #5 /ID# 149832
City
Nizhnij Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Orenburg State Medical Academy /ID# 145992
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Republican Clin Hos n.a. Baran /ID# 147251
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Samara Regional Clinical Hosp /ID# 150934
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Reg Clin Hosp n.a. Kuvatova G. /ID# 144757
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Yaroslavi State Medical Univer /ID# 147253
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
Institute for Rheumatology /ID# 144759
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 144761
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 144762
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Special Hospital for Rheuma /ID# 144760
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Wits Clinical Research Site /ID# 149835
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
University of Pretoria /ID# 148740
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Synexus Helderberg Clinical Tr /ID# 148724
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Tiervlei Trial Centre /ID# 153086
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Hospital Plató /ID# 145999
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Univ Germans Trias I /ID# 146037
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Infanta Luisa /ID# 144771
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hospital Universitario de Valm /ID# 144770
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario La Fe /ID# 158013
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Uludağ Üniversitesi Atatürk Rehabilitasyon Uygulama ve Araştırma Merkezi /ID# 144772
City
Osmangazi
State/Province
Bursa
ZIP/Postal Code
16080
Country
Turkey
Facility Name
Lviv Regional Clinical Hospita /ID# 154448
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 146002
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Regional Clinical Hospital /ID# 152007
City
Ivano-frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
NSC-Strazhesko Ist Cardiology /ID# 152004
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Zaporizhzhia Regional Clinical /ID# 146000
City
Zaporizhia
ZIP/Postal Code
69600
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
31130260
Citation
Smolen JS, Pangan AL, Emery P, Rigby W, Tanaka Y, Vargas JI, Zhang Y, Damjanov N, Friedman A, Othman AA, Camp HS, Cohen S. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019 Jun 8;393(10188):2303-2311. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23. Erratum In: Lancet. 2019 Jun 29;393(10191):2590.
Results Reference
background
PubMed Identifier
36125701
Citation
Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.
Results Reference
derived
PubMed Identifier
34636000
Citation
Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.
Results Reference
derived
PubMed Identifier
34041702
Citation
Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
33313898
Citation
Strand V, Tundia N, Wells A, Buch MH, Radominski SC, Camp HS, Friedman A, Suboticki JL, Dunlap K, Goldschmidt D, Bergman M. Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY. Rheumatology (Oxford). 2021 Jul 1;60(7):3209-3221. doi: 10.1093/rheumatology/keaa770.
Results Reference
derived
PubMed Identifier
33115760
Citation
Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum In: Ann Rheum Dis. 2021 May;80(5):e83.
Results Reference
derived
PubMed Identifier
31610021
Citation
Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com/
Description
Related Info.
Learn more about this trial
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
We'll reach out to this number within 24 hrs