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)

January 3, 2024 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

648

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1128
        • Mautalen Salud e Investigacion /ID# 145980
      • Buenos Aires, Argentina, 1417
        • Ctr Privado Med Familiar /ID# 149183
      • Buenos Aires, Argentina, 1428
        • Consultorio Reumatologic Pampa /ID# 145979
      • Buenos Aires, Argentina, 1431
        • Centro de Educación Médica e Investigaciones Clínicas "Norberto Quimo" - CEMIC /ID# 149176
      • Salta, Argentina, 4400
        • Cordis S.A. /Id# 152621
      • Santa Fe, Argentina, 2000
        • Centro de Enfermedades /ID# 153543
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital /ID# 146028
  • Austria
      • Wien, Austria, 1100
        • Rheuma-Zentrum Wien-Oberlaa /ID# 144728
  • Belgium
      • Genk, Belgium, 3600
        • ReumaClinic Genk /ID# 146030
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 9300
        • Algemeen Stedelijk Ziekenhuis /ID# 148720
  • Bulgaria
      • Sofia, Bulgaria, 1505
        • Diag Consult Ctr 17 Sofia EOOD /ID# 144730
      • Sofia, Bulgaria, 1612
        • UMHAT Sv. Ivan Rilski /ID# 147351
  • Chile
      • Concepcion, Chile, 4070038
        • Reg. Clinical Hosptial Concepcion /ID# 151267
      • Puerto Varas, Chile, 5550170
        • Quantum Research LTDA. /ID# 145984
      • Santiago, Chile, 7500588
        • Quantum Research Stgo. /ID# 145983
  • Czechia
      • Breclav, Czechia, 690 02
        • RHEUMA s.r.o. /ID# 144737
      • Uherské Hradište, Czechia, 686 01
        • Medical Plus, s.r.o. /ID# 144821
    • Olomoucky Kraj
      • Olomouc, Olomoucky Kraj, Czechia, 779 00
        • CTCenter MaVe, s.r.o. /ID# 144823
    • Praha 4
      • Prague 4, Praha 4, Czechia, 140 00
        • Nuselská poliklinika, Revmatologie /ID# 145986
      • Prague 4, Praha 4, Czechia, 140 00
        • Thomayerova nemocnice /ID# 144736
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonian Medical Centre /ID# 145455
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50406
        • MediTrials /ID# 159745
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens "Ippokratio" /ID# 144739
  • Hungary
      • Budapest, Hungary, 1134
        • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 144743
      • Kistarcsa, Hungary, 2143
        • Pest Megyei Flor Ferenc Korhaz /ID# 144742
      • Szekesfehervar, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Korh /ID# 144741
    • Veszprem
      • Veszprém, Veszprem, Hungary, 8200
        • Vital Medical Center Orvosi es /ID# 144740
  • Israel
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center /ID# 144744
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 144745
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel MC /ID# 147174
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center /ID# 144824
  • Italy
      • Verona, Italy, 37134
        • A.O.U.I. di Verona Policlinico /ID# 144746
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Universita di Catanzaro Magna Graecia /ID# 144747
  • Japan
      • Hamamatsu, Japan, 430-8558
        • Seirei Hamamatsu General Hosp /ID# 148270
      • Hyuga, Japan, 883-0043
        • Ohira Orthopaedic Hospital /ID# 157944
      • Nishimura, Japan, 649-2211
        • Shirahama Hamayu Hospital /ID# 148277
      • Sanuki, Japan, 769-2321
        • Sanuki Municipal Hospital /ID# 158080
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital /ID# 148285
      • Sapporo, Japan, 063-0811
        • Hokkaido Medical Center for Rheumatic Diseases /ID# 148274
      • Shunan, Japan, 745-0824
        • Miyasato Clinic /ID# 148271
      • Takaoka, Japan, 933-0874
        • Takaoka Rheumatic Orthopedic Clinic /ID# 148068
      • Tokyo, Japan, 155-0032
        • Matsuta Clinic /ID# 148278
      • Yotsukaido, Japan, 284-0003
        • National Hospital Organization Shimoshizu National Hospital /ID# 148273
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 810-0001
        • Kondo Clinic for Rheum & Ortho /ID# 148268
      • Fukuoka-shi, Fukuoka, Japan, 810-8563
        • NHO Kyushu Medical Center /ID# 148279
      • Fukuoka-shi, Fukuoka, Japan, 810-8563
        • NHO Kyushu Medical Center /ID# 148280
      • Iizuka-shi, Fukuoka, Japan, 820-8505
        • Aso Iizuka Hospital /ID# 148272
    • Gunma
      • Takasaki, Gunma, Japan, 3700053
        • Inoue Hospital /ID# 148069
    • Kochi
      • Kochi-shi, Kochi, Japan, 781-0112
        • Bay Side Misato Medical Center /ID# 148281
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 862-0920
        • Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148269
      • Kumamoto-shi, Kumamoto, Japan, 8628655
        • Kumamoto Shinto General Hospital /ID# 148286
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital /ID# 149859
      • Sasebo-city, Nagasaki, Japan, 857-1195
        • Sasebo Chuo Hospital /ID# 148275
    • Osaka
      • Osaka-shi, Osaka, Japan, 543-8555
        • Osaka Red Cross Hospital /ID# 148267
  • Mexico
      • Mexico City, Mexico, 06100
        • Cryptex Investigación Clínica S.A de C.V /ID# 147095
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64060
        • Desarrollos Biomedicos y Biotc /ID# 147379
  • Poland
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 51-685
        • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 157622
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-607
        • REUMED Sp.z o.o. Filia nr 1 /ID# 144752
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149521
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-351
        • Osteo-Medic spolka cywilna /ID# 144753
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badań Klinicznych Pi-House /ID# 149520
    • Warminsko-mazurskie
      • Elblag, Warminsko-mazurskie, Poland, 82-300
        • NZOZ Centrum Reumatologiczne /ID# 144749
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-218
        • Medyczne Centrum Hetmanska /ID# 144751
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Lisboa Norte, EPE /ID# 146035
      • Porto, Portugal, 4050-111
        • Centro Hospitalar Baixo Vouga /ID# 152916
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1050-034
        • Instituto Portugues De Reumatologia /ID# 149281
    • Porto
      • Vila Nova De Gaia, Porto, Portugal, 4434-502
        • Centro Hospitalar De Vila Nova /ID# 146036
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Dr. Ramon L. Ortega-Colon, MD /ID# 145989
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine /ID# 145990
  • Romania
      • Ploiesti, Romania, 100337
        • Spitalul Municipal Ploiesti /ID# 144756
  • Russian Federation
      • Ivanovo, Russian Federation, 153005
        • Сity Clinical Hospital 4 /ID# 145994
      • Moscow, Russian Federation, 125284
        • City Clinical Hospital Botkina /ID# 145995
      • Nizhnij Novgorod, Russian Federation, 603005
        • City Clinical Hospital #5 /ID# 149832
      • Orenburg, Russian Federation, 460000
        • Orenburg State Medical Academy /ID# 145992
      • Petrozavodsk, Russian Federation, 185019
        • Republican Clin Hos n.a. Baran /ID# 147251
      • Samara, Russian Federation, 443095
        • Samara Regional Clinical Hosp /ID# 150934
      • UFA, Russian Federation, 450005
        • Reg Clin Hosp n.a. Kuvatova G. /ID# 144757
      • Yaroslavl, Russian Federation, 150000
        • Yaroslavi State Medical Univer /ID# 147253
    • Moskva
      • Moscow, Moskva, Russian Federation, 119049
        • Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 147255
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
        • LLC Medical Center /ID# 144758
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614109
        • Perm Clinical Center of FMBA /ID# 145993
    • Tverskaya Oblast
      • Tver, Tverskaya Oblast, Russian Federation, 170036
        • Tver Regional Clinical Hosp. /ID# 147254
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 144759
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 144761
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 144762
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Special Hospital for Rheuma /ID# 144760
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Site /ID# 149835
      • Pretoria, Gauteng, South Africa, 0001
        • University of Pretoria /ID# 148740
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Synexus Helderberg Clinical Tr /ID# 148724
      • Cape Town, Western Cape, South Africa, 7530
        • Tiervlei Trial Centre /ID# 153086
  • Spain
      • Barcelona, Spain, 08006
        • Hospital Plató /ID# 145999
      • Barcelona, Spain, 08916
        • Hospital Univ Germans Trias I /ID# 146037
      • Sevilla, Spain, 41010
        • Hospital Infanta Luisa /ID# 144771
      • Sevilla, Spain, 41014
        • Hospital Universitario de Valm /ID# 144770
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe /ID# 158013
  • Turkey
    • Bursa
      • Osmangazi, Bursa, Turkey, 16080
        • Uludağ Üniversitesi Atatürk Rehabilitasyon Uygulama ve Araştırma Merkezi /ID# 144772
  • Ukraine
      • Ivano-frankivsk, Ukraine, 76018
        • Regional Clinical Hospital /ID# 152007
      • Kiev, Ukraine, 03680
        • NSC-Strazhesko Ist Cardiology /ID# 152004
      • Zaporizhia, Ukraine, 69600
        • Zaporizhzhia Regional Clinical /ID# 146000
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79013
        • Lviv Regional Clinical Hospita /ID# 154448
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21018
        • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 146002
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Rheum Assoc of North Alabama /ID# 146009
      • Mobile, Alabama, United States, 36608-1787
        • Alabama Medical Group, PC /ID# 153941
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • ArthroCare Arthritis Care & Re /ID# 143751
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC /ID# 143760
      • Tucson, Arizona, United States, 85719-1478
        • University of Arizona Cancer Center - North Campus /ID# 147175
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Womens Clinic /ID# 148904
    • California
      • Hemet, California, United States, 92543
        • C.V. Mehta MD, Med Corporation /ID# 143762
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Arthritis Assoc & Osteo Ctr /ID# 147176
    • Florida
      • Fort Lauderdale, Florida, United States, 33309
        • Ctr Rheum, Immuno, Arthritis /ID# 143766
      • Miami Springs, Florida, United States, 33166-7225
        • South Florida Research Ph I-IV /ID# 151983
      • Pinellas Park, Florida, United States, 33781
        • Advent Clinical Research /ID# 143767
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Center /ID# 146011
      • Tamarac, Florida, United States, 33321
        • W. Broward Rheum Assoc Inc. /ID# 146010
      • Tampa, Florida, United States, 33603
        • Clinical Research West FL /ID# 148726
      • Tampa, Florida, United States, 33609
        • SW FL Clin Res Ctr, Tampa, FL /ID# 143763
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 146004
      • Tampa, Florida, United States, 33614-7101
        • BayCare Medical Group, Inc. /ID# 151985
      • Tampa, Florida, United States, 33614-7101
        • BayCare Medical Group, Inc. /ID# 163595
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Jefrey D. Lieberman, MD, P.C. /ID# 151816
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials /ID# 150935
    • Kansas
      • Wichita, Kansas, United States, 67205
        • PRN Professional Research Network of Kansas, LLC /ID# 143761
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836-6455
        • Ochsner Clinic Foundation /ID# 153573
      • Monroe, Louisiana, United States, 71203
        • The Arthritis & Diabetes Clinic, Inc. /ID# 160809
      • Shreveport, Louisiana, United States, 71011
        • Vanguard Medical Research, LLC /ID# 153124
    • Massachusetts
      • Mansfield, Massachusetts, United States, 02048
        • Mansfield Health Center /ID# 161627
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research Inc. /ID# 156415
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 146008
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc /ID# 147618
      • Las Cruces, New Mexico, United States, 88011
        • Arthritis and Osteo Assoc /ID# 147177
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Coastal Carolina Health Care /ID# 149275
    • Ohio
      • Vandalia, Ohio, United States, 45377-9464
        • STAT Research, Inc. /ID# 143770
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research Oklahoma /ID# 159550
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultant /ID# 147632
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Innovative Clinical Research /ID# 143757
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Arthritis and Rheumatology /ID# 162641
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc. /ID# 159554
      • Beaumont, Texas, United States, 77701
        • Diagnostic Group Integrated He /ID# 148725
      • Carrollton, Texas, United States, 75007
        • Trinity Universal Res Assoc /ID# 150138
      • College Station, Texas, United States, 77845
        • Arth and Osteo Clin Brazo Valley /ID# 160810
      • Corpus Christi, Texas, United States, 78404
        • Adriana Pop-Moody MD Clinic PA /ID# 147627
      • Houston, Texas, United States, 77004
        • Accurate Clinical Management /ID# 143768
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research /ID# 143769
      • Houston, Texas, United States, 77098-5294
        • Pioneer Research Solutions, Inc. /ID# 143765
      • Lufkin, Texas, United States, 75904-3132
        • P&I Clinical Research /ID# 151358
      • Mesquite, Texas, United States, 75150
        • SW Rheumatology Res. LLC /ID# 147620
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute /ID# 159553
      • San Marcos, Texas, United States, 78666
        • Arthritis Clinic of Central TX /ID# 149266
      • The Woodlands, Texas, United States, 77382
        • Adv Rheumatology of Houston /ID# 162609
      • Tomball, Texas, United States, 77375
        • DM Clinical Research /ID# 151359
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic /ID# 143752
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Ctr for Arth and Rheum Disease /ID# 143759
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Aurora Rheumatology and Immunotherapy Center /ID# 160811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upadacitinib 30 mg

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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo Methotrexate
Capsule; Oral
Experimental: Upadacitinib 15 mg

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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo Methotrexate
Capsule; Oral
Experimental: Methotrexate / Upadacitinib 30 mg

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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo Upadacitinib
Tablet; Oral
Drug: Placebo Methotrexate
Capsule; Oral
Drug: Methotrexate
Capsule; Oral
Experimental: Methotrexate / Upadacitinib 15 mg

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.
Drug: Upadacitinib
Tablet; Oral
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo Upadacitinib
Tablet; Oral
Drug: Placebo Methotrexate
Capsule; Oral
Drug: Methotrexate
Capsule; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14
Time Frame: Baseline and 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:

  1. ≥ 20% improvement in 68-tender joint count;
  2. ≥ 20% improvement in 66-swollen joint count; and

  3. ≥ 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 and week 14
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14
Time Frame: 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.
Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14
Time Frame: Baseline to 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.
Baseline to week 14
Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14
Time Frame: Baseline to 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.
Baseline to week 14
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14
Time Frame: Baseline to 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.
Baseline to week 14
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14
Time Frame: 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.
Week 14
Change From Baseline in Duration of Morning Stiffness at Week 14
Time Frame: Baseline to 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.
Baseline to week 14
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14
Time Frame: Baseline and week 14

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:

  1. ≥ 50% improvement in 68-tender joint count;
  2. ≥ 50% improvement in 66-swollen joint count; and

  3. ≥ 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 and week 14
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14
Time Frame: Baseline and week 14

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:

  1. ≥ 70% improvement in 68-tender joint count;
  2. ≥ 70% improvement in 66-swollen joint count; and

  3. ≥ 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 and week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2016

Primary Completion (Actual)

October 2, 2017

Study Completion (Actual)

August 10, 2022

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimated)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-555
  • 2015-003376-75 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Upadacitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe