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A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02629159
Recruitment Status : Active, not recruiting
First Posted : December 14, 2015
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):

Brief Summary:
This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a stable background of Methotrexate (MTX) and who have an inadequate response to MTX.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Placebo for Adalimumab Drug: ABT-494 Drug: Adalimumab Drug: Placebo for ABT-494 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : October 27, 2017
Estimated Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Placebo Comparator: Placebo followed by ABT-494
Placebo once every two weeks for subcutaneous injection and once daily for oral tablet for 26 weeks (Period 1) followed by ABT-494 once daily for up to 5 years (Period 2).
Drug: Placebo for Adalimumab
Placebo subcutaneous Injection

Drug: ABT-494
ABT-494 Oral Tablet
Other Name: Upadacitinib

Drug: Placebo for ABT-494
Placebo Oral Tablet

Active Comparator: Adalimumab (ADA)
Subcutaneous injection once every two weeks
Drug: Adalimumab
Adalimumab subcutaneous injection

Experimental: ABT-494
Once daily
Drug: ABT-494
ABT-494 Oral Tablet
Other Name: Upadacitinib

Primary Outcome Measures :
  1. Proportion of participants achieving American College of Rheumatology (ACR) 20 Response [ Time Frame: At week 12 ]
    American College of Rheumatology (ACR) 20 response rate will be determined based on 20% or greater improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and greater than or equal to 3 of the 5 measures of Patient's Assessment of Pain (Visual Analog Scale [VAS]), Patient's Global Assessment of Disease Activity (VAS), Physician's Global Assessment of Disease Activity (VAS), Health Assessment Questionnaire Disability Index (HAQ-DI), or High Sensitivity - C Reactive Protein (hsCRP).

  2. Proportion of subjects achieving Clinical remission (CR) based on Disease Activity 28 (DAS28) C-Reactive Protein (CRP) [ Time Frame: At Week 12 ]
    CR based on DAS28 (CRP) response rate is defined as DAS28 (CRP) less than 2.6

Secondary Outcome Measures :
  1. Change in Health Assessment Questionnaire (HAQ-DI) [ Time Frame: From Day 1 to Week 12 ]
    HAQ-DI is a participant questionnaire with questions regarding the participant's illness and how it affect their daily life activities.

  2. Proportion of subjects achieving Low Disease Activity (LDA) based on Clinical Disease Activity Index (CDAI) [ Time Frame: At week 12 ]
    Proportion of participants achieving low disease activity as defined by Clinical Disease Activity Index (CDAI) is assessed.

  3. Proportion of subjects with no radiographic progression [ Time Frame: At week 26 ]
    Radiographic progression is defined as a change from baseline Modified Total Sharp Score (mTSS) that is greater than 0.

  4. Change in Morning Stiffness severity [ Time Frame: From Day 1 to Week 12 ]
    Morning Stiffness severity is determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. The severity score is based on a single 0 to 10 rating scale with 0 indicating "No morning stiffness" and 10 indicating "Worst possible morning stiffness".

  5. Change in Disease Activity Score (DAS) 28 (CRP). [ Time Frame: From Day 1 to Week 12 ]
    DAS28(CRP) score will be determined based on a continuous scale of combined measures of TJC, SJC, Patient's Global Assessment of Disease Activity (PtGA) (in mm), and hsCRP (in mg/L)

  6. Change in Short Form 36 (SF-36) Physical Component Score (PCS) [ Time Frame: From Day 1 to Week 12 ]
    SF-36 is a 36 item participant questionnaire with questions regarding participant health and daily activities.

  7. Change in Functional Assessment of Chronic Illness Therapy (FACIT-F) [ Time Frame: From Day 1 to Week 12 ]
    FACIT-F is participant questionnaire with 13 indexes rated on a 5 point scale. The indexes generally relate to the participant's level of fatigue during the past 7 days.

  8. Change in modified Total Sharp Score (mTSS) [ Time Frame: From Day 1 to Week 26 ]
    For mTSS, the erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.

  9. Proportion of participants achieving American College of Rheumatology (ACR) 50 [ Time Frame: At week 12 ]
    ACR 50 response rate will be determined based on 50% or greater improvement in TJC and SJC and greater than or equal to 3 of the 5 measures of Patient's Assessment of Pain (VAS), Patient's Global Assessment of Disease Activity (VAS), Physician's Global Assessment of Disease Activity (VAS), HAQ-DI, or hsCRP

  10. Proportion of participants achieving American College of Rheumatology (ACR) 70 [ Time Frame: At Week 12 ]
    ACR 70 response rate will be determined based on 70% or greater improvement in TJC and SJC and greater than or equal to 3 of the 5 measures of Patient's Assessment of Pain (VAS), Patient's Global Assessment of Disease Activity (VAS), Physician's Global Assessment of Disease Activity (VAS), HAQ-DI, or hsCRP

  11. Proportion of subjects achieving Low Disease Activity (LDA) based on Disease Activity 28 (DAS28) C-Reactive Protein (CRP) [ Time Frame: At week 12 ]
    Proportion of participants achieving low disease activity as defined by a clinical response (DAS28[CRP] less than or equal to 3.2). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than or equal to 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

  12. Change from baseline in Patient's Assessment of Pain at Week 12 (superiority of upadacitinib vs.ADA) [ Time Frame: At Week 12 ]
    Change from baseline in Patient's Assessment of Pain is assessed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult male or female, at least 18 years old.
  • Diagnosis of RA for greater than or equal to 3 months.
  • Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for greater than or equal to 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
  • Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
  • At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
  • Subjects with prior exposure to only one Biological disease-modifying anti-rheumatic drugs (bDMARD) (except ADA) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
  • Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
  • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02629159

  Hide Study Locations
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United States, Alabama
Achieve Clinical Research, LLC /ID# 143136
Birmingham, Alabama, United States, 35216
United States, Arizona
AZ Arthritis and Rheum Assoc /ID# 143130
Mesa, Arizona, United States, 85202
SunValley Arthritis Center, Lt /ID# 143123
Peoria, Arizona, United States, 85381
Elite Clinical Studies, LLC /ID# 144881
Phoenix, Arizona, United States, 85018
AZ Arthritis and Rheum Researc /ID# 143080
Phoenix, Arizona, United States, 85032-9306
AZ Arthritis and Rheum Researc /ID# 143121
Phoenix, Arizona, United States, 85032-9306
AZ Arthritis & Rheuma Research /ID# 143131
Phoenix, Arizona, United States, 85032
Arizona Research Center, Inc. /ID# 144877
Phoenix, Arizona, United States, 85053-4061
AZ Arthritis & Rheum Research /ID# 156093
Sun City, Arizona, United States, 85351
University Arizona Cancer Ctr /ID# 143114
Tucson, Arizona, United States, 85719-1478
United States, California
Osteoporosis Medical Center /ID# 153935
Beverly Hills, California, United States, 90211
T. Joseph Raoof, MD, Inc. /ID# 144884
Encino, California, United States, 91436
Rheumatology Ctr of San Diego /ID# 153747
Escondido, California, United States, 92025
C.V. Mehta MD, Med Corporation /ID# 143116
Hemet, California, United States, 92543
Allergy and Rheum Med Clin /ID# 146083
La Jolla, California, United States, 92037
Kotha and Kotha /ID# 161046
La Mesa, California, United States, 91942
TriWest Research Associates- La Mesa /ID# 143115
La Mesa, California, United States, 91942
Valerius Med Grp & Res Ctr /ID# 143120
Los Alamitos, California, United States, 90720-5402
Discovery MM Services, Inc /ID# 163504
Los Angeles, California, United States, 11373
Desert Medical Advances /ID# 143097
Palm Desert, California, United States, 92260
Sierra Rheumatology /ID# 155672
Roseville, California, United States, 95661
Robin K. Dore MD, Inc /ID# 143090
Tustin, California, United States, 92780
Medvin Clinical Research /ID# 148362
Whittier, California, United States, 90606
United States, Colorado
Arthritis Assoc & Osteo Ctr /ID# 143122
Colorado Springs, Colorado, United States, 80920
Arthritis and Rheum Clin N. CO /ID# 156094
Fort Collins, Colorado, United States, 80528
United States, Florida
AARDS Research, Inc. /ID# 154190
Aventura, Florida, United States, 33180
ZASA Clinical Research /ID# 143134
Boynton Beach, Florida, United States, 33472
Clinical Res of West FL, Inc. /ID# 143112
Clearwater, Florida, United States, 33765
International Medical Research /ID# 143132
Daytona Beach, Florida, United States, 32117
Precision Research Org, LLC /ID# 143092
Miami Lakes, Florida, United States, 33016-1501
Lakes Research, LLC /ID# 145630
Miami, Florida, United States, 33014
FL Med Ctr and Research, Inc. /ID# 143081
Miami, Florida, United States, 33142
Ctr Arthritis & Rheumatic Dise /ID# 143135
Miami, Florida, United States, 33173
Advanced Clin Res of Orlando /ID# 154617
Ocoee, Florida, United States, 34761-4547
Rheum Assoc of Central FL /ID# 145632
Orlando, Florida, United States, 32806
Omega Research Consultants /ID# 145635
Orlando, Florida, United States, 32810
HMD Research LLC /ID# 163292
Orlando, Florida, United States, 32819
Arthritis Research of Florida /ID# 143125
Palm Harbor, Florida, United States, 34684-2672
Arthritis Center, Inc. /ID# 145647
Palm Harbor, Florida, United States, 34684
St. Anthony Comprehsve Res Ins /ID# 143095
Saint Petersburg, Florida, United States, 33705
Clinical Research West FL /ID# 148358
Tampa, Florida, United States, 33603
SW FL Clin Res Ctr, Tampa, FL /ID# 143117
Tampa, Florida, United States, 33609
BayCare Medical Group, Inc. /ID# 143085
Tampa, Florida, United States, 33614-7101
Lovelace Scientific Resources /ID# 143106
Venice, Florida, United States, 34292
United States, Georgia
Arthritis and Rheumatology /ID# 155668
Atlanta, Georgia, United States, 30342
Arthritis Center of North GA /ID# 155258
Gainesville, Georgia, United States, 30501
North Georgia Rheumatology Grp /ID# 147170
Lawrenceville, Georgia, United States, 30045
United States, Idaho
Advanced Clinical Research /ID# 153090
Meridian, Idaho, United States, 83642
United States, Illinois
Great Lakes Clinical Trials /ID# 148357
Chicago, Illinois, United States, 60640
United States, Maryland
Arthritis Treatment Center /ID# 155260
Frederick, Maryland, United States, 21204
The Center for Rheumatology & /ID# 151356
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Clinical Pharmacology Study Gr /ID# 143082
Worcester, Massachusetts, United States, 01605
United States, Michigan
Advanced Rheumatology, PC /ID# 143118
Lansing, Michigan, United States, 48910
Shores Rheumatology, PC /ID# 162977
Saint Clair Shores, Michigan, United States, 48081
United States, Minnesota
St. Luke's Hospital /ID# 156750
Duluth, Minnesota, United States, 55805
United States, Mississippi
North Mississippi Med Clinics /ID# 145636
Tupelo, Mississippi, United States, 38801
United States, Nebraska
Physician Res. Collaboration /ID# 143087
Lincoln, Nebraska, United States, 68516
Quality Clinical Research Inc. /ID# 156394
Omaha, Nebraska, United States, 68114
United States, New Jersey
Atlantic Coast Research /ID# 148355
Toms River, New Jersey, United States, 08755
Ocean Rheumatology, PA /ID# 143111
Toms River, New Jersey, United States, 08755
Arthritis Rheumatic Back Disorder /ID# 143102
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque Clinical Trials, Inc /ID# 143083
Albuquerque, New Mexico, United States, 87102
Arthritis and Osteo Assoc /ID# 143127
Las Cruces, New Mexico, United States, 88011
United States, New York
St. Lawrence Health System /ID# 161619
Potsdam, New York, United States, 13676
United States, North Carolina
Joint & Muscle Research Instit /ID# 143119
Charlotte, North Carolina, United States, 28204
DJL Clinical Research, PLLC /ID# 143101
Charlotte, North Carolina, United States, 28210-8508
EmergeOrtho, P.A. /ID# 143100
Durham, North Carolina, United States, 27704
Cape Fear Arthritis Care /ID# 148361
Leland, North Carolina, United States, 28451
Coastal Carolina Health Care /ID# 148359
New Bern, North Carolina, United States, 28562
Shanahan Rheuma & Immuno /ID# 145643
Raleigh, North Carolina, United States, 27617
United States, Ohio
Clinical Research Solutions, LLC /ID# 154619
Dayton, Ohio, United States, 45409
Arthritis Assoc of NW Ohio /ID# 143094
Toledo, Ohio, United States, 43606
United States, Oklahoma
Healthcare Research Consultant /ID# 143129
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Altoona Ctr Clinical Res /ID# 143110
Duncansville, Pennsylvania, United States, 16635
Clinical Research Ctr Reading /ID# 143133
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Columbia Arthritis Center /ID# 153730
Columbia, South Carolina, United States, 29204
Innovative Clinical Research /ID# 145637
Greenville, South Carolina, United States, 29601
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091
Summerville, South Carolina, United States, 29486-7887
United States, Tennessee
Arthritis Associates, PLLC /ID# 155490
Kingsport, Tennessee, United States, 37660
Rheumatology Consultants, PLLC /ID# 153731
Knoxville, Tennessee, United States, 37909
Dr. Ramesh Gupta /ID# 143099
Memphis, Tennessee, United States, 38119
United States, Texas
Austin Regional Clinic /ID# 143084
Austin, Texas, United States, 78731
Diagnostic Group Integrated He /ID# 148356
Beaumont, Texas, United States, 77701
Arthritis Care and Diagnostic /ID# 150677
Dallas, Texas, United States, 75231
Metroplex Clinical Research /ID# 145631
Dallas, Texas, United States, 75231
Doctor's Hosp at Renaissance /ID# 154616
Edinburg, Texas, United States, 78539
MedResearch Inc. /ID# 154618
El Paso, Texas, United States, 79935
Accurate Clinical Management /ID# 145644
Houston, Texas, United States, 77004
Accurate Clinical Research /ID# 145645
Houston, Texas, United States, 77034
Rheumatology Clinic of Houston /ID# 150921
Houston, Texas, United States, 77065
Houston Institute for Clin Res /ID# 144879
Houston, Texas, United States, 77074
Pioneer Research Solutions, Inc. /ID# 145640
Houston, Texas, United States, 77098-5294
Arthritis Consultants, P.A. /ID# 144880
Killeen, Texas, United States, 76549
Arthritis & Osteoporosis Assoc /ID# 147364
Lubbock, Texas, United States, 79424
P&I Clinical Research /ID# 161625
Lufkin, Texas, United States, 75904-3132
SW Rheumatology Res. LLC /ID# 143126
Mesquite, Texas, United States, 75150
Discovery MM Services, Inc. /ID# 162578
Missouri City, Texas, United States, 77459-4750
Discovery MM Services, Inc. /ID# 163183
Missouri City, Texas, United States, 77459-4750
Discovery MM Services, Inc. /ID# 163184
Missouri City, Texas, United States, 77459-4750
Sun Research Institute /ID# 159539
San Antonio, Texas, United States, 78215
Accurate Clinical Management /ID# 143089
San Antonio, Texas, United States, 78229
Arthritis & Osteo Ctr of S. TX /ID# 143103
San Antonio, Texas, United States, 78232
DM Clinical Research /ID# 151357
Tomball, Texas, United States, 77375
United States, Virginia
Arthritis Clinic of N. VA, P.C /ID# 143109
Arlington, Virginia, United States, 22205
Ctr for Arth and Rheum Disease /ID# 143113
Chesapeake, Virginia, United States, 23320
United States, Washington
Arthritis Northwest, PLLC /ID# 143088
Spokane, Washington, United States, 99204
The Vancouver Clinic, INC. PS /ID# 143107
Vancouver, Washington, United States, 98664
United States, West Virginia
West Virginia Research Inst /ID# 153088
South Charleston, West Virginia, United States, 25309
United States, Wisconsin
Rheumatology and Immunotherapy /ID# 145646
Franklin, Wisconsin, United States, 53132
Aprillus Asistencia e Investig /ID# 148406
Capital Federal, Buenos Aires, Argentina, 1046
Mautalen Salud e Investigacion /ID# 142843
Buenos Aires, Argentina, 1128
Fundacion Sanatorio Guemes /ID# 148405
Buenos Aires, Argentina, 1180
Consultorio Reumatologic Pampa /ID# 144853
Buenos Aires, Argentina, 1428
Cemic /Id# 148404
Buenos Aires, Argentina, 1431
Org Medica de Investigacion /ID# 144855
Buenos Aires, Argentina, C1015ABO
Inst. Rheumatologic Strusberg /ID# 145601
Cordoba, Argentina, 5000
Consultora Integral de Salud S /ID# 144856
Cordoba, Argentina, 5900
Instituto CAICI /ID# 144854
Rosario, Santa FE, Argentina, 2000
Cordis S.A. /Id# 152622
Salta, Argentina, 4400
Iari /Id# 151293
San Fernando, Argentina, 1646
Centro Integral de Reumatologi /ID# 142845
San Miguel de Tucuman, Argentina, 4000
Centro Medico Privado/Reuma /ID# 142842
San Miguel de Tucuman, Argentina, 4000
Centro de Enfermedades /ID# 153542
Santa Fe, Argentina, 2000
Australia, New South Wales
Royal Prince Alfred Hospital /ID# 144857
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Emeritus Research /ID# 142848
Camberwell, Victoria, Australia, 3124
LKH-Univ. Klinikum Graz /ID# 142851
Graz, Austria, 8036
First City Clinical Hospital /ID# 158011
Minsk, Belarus, 220013
Cliniques Universitaires Saint Luc /ID# 142858
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Rhumaconsult SPRL /ID# 142860
Charleroi, Hainaut, Belgium, 6000
CHU de Liege /ID# 148401
Liège, Liege, Belgium, 4000
UZ Gent /ID# 142859
Gent, Oost-Vlaanderen, Belgium, 9000
CHU Ambroise Pare /ID# 152953
Mons, Belgium, 7000
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 142862
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 142863
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
Clinical Center University of Sarajevo /ID# 142865
Sarajevo, Bosnia and Herzegovina, 71000
CIP - Centro Internacional de Pesquisa /ID# 142872
Goiânia, Goias, Brazil, 74110-120
Hc Ufmg /Id# 142868
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871
Curitiba, Parana, Brazil, 80030-110
Hospital de Clinicas de Porto Alegre /ID# 142870
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
LMK Sevicos Medicos S/S /ID# 142869
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867
São Paulo, Sao Paulo, Brazil, 04266-010
CCBR Brasil /ID# 150918
Rio de Janeiro, Brazil, 22271-100
MHAT Trimontsium /ID# 142874
Plovdiv, Bulgaria, 4000
UMHAT Pulmed OOD /ID# 142877
Plovdiv, Bulgaria, 4000
MHAT Kaspela /ID# 142873
Plovdiv, Bulgaria, 4001
Diagnostic Consultative Center /ID# 142875
Sofia, Bulgaria, 1612
UMHAT Sv. Ivan Rilski /ID# 142876
Sofia, Bulgaria, 1612
Canada, Manitoba
Manitoba Clinic /ID# 161434
Winnipeg, Manitoba, Canada, R3A IM3
Ciads /Id# 142880
Winnipeg, Manitoba, Canada, R3N 0K6
Canada, Newfoundland and Labrador
St. Clare's Mercy Hospital /ID# 142879
St. John's, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Ontario
Adachi Medicine Prof. Corp /ID# 154205
Hamilton, Ontario, Canada, L8N 1Y2
CA Ctr for Clin Trials CCCT /ID# 157379
Thornhill, Ontario, Canada, L4J 1W3
Canada, Quebec
Groupe de Recherche en Maladies Osseuses /ID# 142878
Sainte-foy, Quebec, Canada, G1V 3M7
Ctr de Inv Clinica del Sur /ID# 142888
Temuco, Araucania, Chile, 4781156
Reg. Clinical Hosptial Concepcion /ID# 151271
Concepcion, Chile, 4070038
Corp de Beneficencia Osorno /ID# 147941
Osorno, Chile, 1710216
Someal /Id# 144704
Providencia-santiago, Chile, 7510186
Quantum Research LTDA. /ID# 142893
Puerto Varas, Chile, 5550170
Quantum Research Stgo. /ID# 157933
Santiago, Chile, 7500588
Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890
Santiago, Chile, 7510047
Clinica DermaCross /ID# 142892
Santiago, Chile, 7640881
Investigaciones Medicas SSMSO /ID# 151686
Santiago, Chile, 8207257
Centro Inter Estud Clin CIEC /ID# 144777
Santiago, Chile, 8420383
Centro Medico de Reumatologia /ID# 148402
Temuco, Chile, 4790928
Cinvec /Id# 144705
Vina Del Mar, Chile, 2520997
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898
Bogota, Cundinamarca, Colombia, 110221
Ctr Int de Reum del Caribe SAS /ID# 142894
Barranquilla, Colombia, 80002
Fund Inst de Reum F. Chalem /ID# 149847
Bogota DC, Colombia
Riesgo de Fractura S.A - CAYRE /ID# 142896
Bogota, Colombia, 110221
Medicity S.A.S. /ID# 144860
Bucaramanga, Colombia, 680003
Centro Integral de Reumatologi /ID# 142897
Medellín, Colombia, 50021
Klinicki bolnicki centar Rijeka /ID# 160232
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Klinicki bolnicki centar Split /ID# 152530
Split, Croatia, 21000
Clinical Hospital Dubrava /ID# 142900
Zagreb, Croatia, 10000
Medical Center Kuna-Peric /ID# 142901
Zagreb, Croatia, 10000
Poliklinika Bonifarm /ID# 142899
Zagreb, Croatia, 10000
L.K.N. Arthrocentrum, s.r.o /ID# 145961
Hlučín, Moravskoslezsky Kraj, Czechia, 748 01
CTCenter MaVe, s.r.o. /ID# 142905
Olomouc, Olomoucky Kraj, Czechia, 779 00
Revmatologicky ustav Praha /ID# 142904
Prague 2, Praha 2, Czechia, 128 00
Nuselská poliklinika, Revmatologie /ID# 144862
Prague 4, Praha 4, Czechia, 140 00
Revmatologická ambulance /ID# 145963
Prague 4, Praha 4, Czechia, 140 00
Thomayerova nemocnice /ID# 145962
Prague 4, Praha 4, Czechia, 140 00
REVMACLINIC s.r.o. /ID# 142906
Brno, Czechia, 611 41
Revmatologie Bruntal, s.r.o /ID# 142903
Bruntál, Czechia, 79201
Revmatologicka a interni ambul /ID# 142907
Kladno, Czechia, 272 01
Revmatologie MUDr. Klara Sirov /ID# 142908
Ostrava, Czechia, 702 00
Arthromed, s.r.o. /ID# 144706
Pardubice, Czechia, 530 02
Aarhus University Hospital /ID# 158838
Aarhus N, Midtjylland, Denmark, 8200
Regionhospital Silkeborg /ID# 142914
Silkeborg, Denmark, 8600
Center of Clinical and Basic Research /ID# 142922
Tallinn, Harjumaa, Estonia, 10128
MediTrials /ID# 151870
Tartu, Tartumaa, Estonia, 50406
Paernu Hospital /ID# 142921
Pärnu, Estonia, 80010
East Tallinn Central Hospital /ID# 142923
Tallinn, Estonia, 10138
North Estonian Medical Centre /ID# 145454
Tallinn, Estonia, 13419
Hopital Universitaire Purpan /ID# 144707
Toulouse, Haute-Garonne, France, 31059
CHRU Lille - Hôpital Claude Huriez /ID# 151312
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Saint Eloi /ID# 142925
Montpellier CEDEX 5, Herault, France, 34295
CHU Bordeaux-Hopital Pellegrin /ID# 145618
Bordeaux, France, 33076
Hopital de la Cote de Nacre /ID# 145616
Caen, France, 14033
CHU Gabriel Montpied /ID# 145619
Clermont Ferrand, France, 63000
Hopital de la Conception /ID# 142926
Marseille, France, 13005
Hopital Pitie Salpetriere /ID# 145605
Paris, France, 75651
CHU de Rennes - Hospital Sud /ID# 151957
Rennes, France, 35203
CHU Strasbourg Hautepierre Hos /ID# 144708
Strasbourg, France, 67200
Rheumazentrum Ruhrgebiet /ID# 145620
Herne, Nordrhein-Westfalen, Germany, 44649
Uniklinik Koln /ID# 145964
Köln, Nordrhein-Westfalen, Germany, 50937
Praxis Walter, Rendsburg /ID# 142932
Rendsburg, Schleswig-Holstein, Germany, 24768
Med Versorgungszentrum AGILOME /ID# 154975
Chemnitz, Germany, 9126
Rheumaforschungszentrum II /ID# 142930
Hamburg, Germany, 20095
LMU Klinikum der Universität München /ID# 142931
Munich, Germany, 80337
General Hospital of Athens Laiko /ID# 142934
Athens, Attiki, Greece, 115 27
University General Hospital "Attikon" /ID# 142933
Athens, Attiki, Greece, 12462
General Hospital of Athens "Ippokratio" /ID# 142935
Athens, Greece, 11527
Hong Kong
Queen Mary Hospital /ID# 142938
Hong Kong, Hong Kong, 999077
Tuen Mun Hospital /ID# 142939
Tuen Mun, Hong Kong, 999077
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Qualiclinic Kft. /ID# 142953
Budapest III, Pest, Hungary, 1036
Markusovszky Egyetemi Oktatókórház /ID# 145621
Szombathely, Vas, Hungary, 9700
Vital Medical Center Orvosi es /ID# 145950
Veszprém, Veszprem, Hungary, 8200
Budai Irgalmasrendi Korhaz /ID# 142952
Budapest, Hungary, 1023
Revita Reumatologiai Rendelo /ID# 142950
Budapest, Hungary, 1027
Synexus Magyarorszag Kft. /ID# 153061
Budapest, Hungary, 1036
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948
Debrecen, Hungary, 4031
Hevizgyogyfurdo es Szent Andra /ID# 142949
Heviz, Hungary, 8380
Kiskunhalasi Semmelweis Korhaz /ID# 151944
Kiskunhalas, Hungary, 6400
Pest Megyei Flor Ferenc Korhaz /ID# 142954
Kistarcsa, Hungary, 2143
St Vincent's University Hosp /ID# 142957
Dublin, Ireland, D04 T6F4
Tel Aviv Sourasky Medical Ctr /ID# 144709
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus /ID# 152050
Haifa, Israel, 3109601
Bnai Zion Medical Center /ID# 151958
Haifa, Israel, 3339419
The Lady Davis Carmel MC /ID# 142960
Haifa, Israel, 3436212
Sheba Medical Center /ID# 145965
Ramat Gan, Israel, 5262100
Istituto Clinico Humanitas /ID# 147528
Rozzano, Milano, Italy, 20089
AOU Citta della Salute Scienza /ID# 150070
Turin, Piemonte, Italy, 10126
Azienda Ospedaliera Luigi Sacc /ID# 142966
Milan, Italy, 20157
A.O.U.I. di Verona Policlinico /ID# 142963
Verona, Italy, 37134
JSC Nat Scientific Med Res Ctr /ID# 142971
Astana, Kazakhstan, 010009
Karaganda State Medical Univ /ID# 153433
Karaganda, Kazakhstan, 100008
Semey State Medical University /ID# 152659
Semey, Kazakhstan, 071403
Regional Clinical Hospital /ID# 147168
Shymkent, Kazakhstan, 160000
Korea, Republic of
Kyungpook National Univ Hosp /ID# 162073
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
Chungnam National University Hospital /ID# 142977
Jung-gu, Daejeon Gwang Yeogsi, Korea, Republic of, 35015
Inha University Hospital /ID# 150886
Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
Chonnam National University Hospital /ID# 142975
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Hanyang University Seoul Hospi /ID# 142979
Seongdong-gu, Seoul Teugbyeolsi, Korea, Republic of, 04763
Cath Univ Seoul St Mary's Hosp /ID# 142976
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Daegu Catholic University Med /ID# 142973
Daegu, Korea, Republic of, 705-718
Seoul National University Hospital /ID# 142978
Seoul, Korea, Republic of, 03080
Asan Medical Center /ID# 142974
Seoul, Korea, Republic of, 05505
LTD M&M Centers /ID# 142984
Adazi, Latvia, 2164
Daugavpils Regional Hospital /ID# 142982
Daugavpils, Latvia, 5417
D.Saulites-Kandevicas PP /ID# 142985
Liepaja, Latvia, 3401
Clinic ORTO /ID# 142983
Riga, Latvia, 1005
Riga East Clinical Univ Hosp /ID# 142981
Riga, Latvia, 1038
Hosp Lithuanian Univ Health Sc /ID# 142986
Kovno, Kaunas, Lithuania, 50009
Vilnius University Hospital /ID# 142987
Vilnius, Lithuania, LT-08661
Hospital Raja Perempuan Zainab II /ID# 157862
Kota Bharu, Kelantan, Malaysia, 15586
Hospital Selayang /ID# 156756
Batu Caves, Malaysia, 68100
Hospital Umum Sarawak /ID# 142990
Kuching, Malaysia, 93586
Hospital Putrajaya /ID# 142989
Putrajaya, Malaysia, 62250
Hospital Tuanku Ja afar /ID# 142988
Seremban, Malaysia, 70300
Hosp. Univ. Dr. Jose E. Gonz /ID# 142992
Monterrey, Nuevo Leon, Mexico, 64320
Invest y Biomed de Chihuahua /ID# 142996
Chihuahua, Mexico, 31000
RM Pharma Specialists, S.A de C.V /ID# 142994
Mexico City, Mexico, 03100
Hospital de Jesús Nazareno /ID# 142993
Mexico City, Mexico, 06090
Clinstile, S.A. de C.V. /ID# 144866
Mexico City, Mexico, 06700
Centro Peninsular de Investiga /ID# 148159
Mérida, Mexico, 97000
New Zealand
Waikato Hospital /ID# 143002
Hamilton, Waikato, New Zealand, 3204
Porter Rheumatology Ltd /ID# 143001
Nelson, New Zealand, 7010
Timaru Medical Specialists Ltd /ID# 143000
Timaru, New Zealand, 7910
WroMedica Irena Bielicka, Janusz Szczepanik s.c. /ID# 145622
Wrocław, Dolnoslaskie, Poland, 51-685
NZOZ Nasz Lekarz /ID# 143004
Toruń, Kujawsko-pomorskie, Poland, 87-100
REUMED Sp.z o.o. Filia nr 1 /ID# 148189
Lublin, Lubelskie, Poland, 20-607
Malopolskie Centrum Kliniczne /ID# 152782
Cracow, Malopolskie, Poland, 30-149
Centrum Medyczne Pratia Krakow /ID# 143005
Krakow, Malopolskie, Poland, 30-002
McBk Sc /Id# 143003
Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960
Warszawa, Mazowieckie, Poland, 02-507
Centrum Medyczne AMED Warszawa Targowek /ID# 157621
Warszawa, Mazowieckie, Poland, 03-291
Osteo-Medic spolka cywilna /ID# 143006
Białystok, Podlaskie, Poland, 15-351
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293
Gdynia, Pomorskie, Poland, 81-384
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294
Gdynia, Pomorskie, Poland, 81-384
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295
Gdynia, Pomorskie, Poland, 81-384
Silmedic Sp z o.o /ID# 152914
Katowice, Slaskie, Poland, 40-282
ClinicMed Badurski i wspolnicy SJ /ID# 163300
Bialystok, Poland, 15-879
Solumed Sp. zoo Cent Medyczne /ID# 152783
Poznan, Poland, 60-425
Rheuma Medicus /ID# 143007
Warsaw, Poland, 02-118
Instituto Portugues De Reumatologia /ID# 148316
Lisbon, Lisboa, Portugal, 1050-034
Centro Hospitalar De Vila Nova /ID# 143010
Vila Nova De Gaia, Porto, Portugal, 4434-502
CCA Braga - Hospital de Braga /ID# 148317
Braga, Portugal, 4710-243
Hospital CUF Descobertas /ID# 160539
Lisbon, Portugal, 1998-018
Centro Hospitalar de Sao Joao, EPE /ID# 152871
Porto, Portugal, 4200-319
Unidade Local De Saude Do Alto Minho /ID# 143009
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
Ponce School of Medicine /ID# 151961
Ponce, Puerto Rico, 00716
GCM Medical Group /ID# 143011
San Juan, Puerto Rico, 00909
Spitalul Clinic Dr. I. Cantacuzino /ID# 143012
Bucharest, Bucuresti, Romania, 020475
Spitalul Clinic Dr. I. Cantacuzino /ID# 143017
Bucharest, Bucuresti, Romania, 020475
Spitalul Clinic Sf. Maria /ID# 144868
Bucuresti, Romania, 011172
Spitalul Clinic Sf. Maria /ID# 144869
Bucuresti, Romania, 011172
Spitalul Clinic Sf. Maria /ID# 145966
Bucuresti, Romania, 011172
Spitalul Clinic de Recuperare /ID# 144867
Iasi, Romania, 700656
Ecomed SRL /ID# 144870
Oradea, Romania, 410028
Russian Federation
Family Outpatient clinic#4,LLC /ID# 148319
Korolev, Moskva, Russian Federation, 141060
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138
Moscow, Moskva, Russian Federation, 119049
Perm Clinical Center of FMBA /ID# 145627
Perm, Permskiy Kray, Russian Federation, 614109
LLC Novaya Klinika /ID# 143019
Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
Kazan State Medical University /ID# 144871
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Tver Regional Clinical Hosp. /ID# 143026
Tver, Tverskaya Oblast, Russian Federation, 170036
Сity Clinical Hospital #4 /ID# 143023
Ivanovo, Russian Federation, 153005
Russian National Research Medi /ID# 143028
Moscow, Russian Federation, 117997
City Clinical Hospital Botkina /ID# 145628
Moscow, Russian Federation, 125284
Moscow State Univ Med and Dent /ID# 145623
Moscow, Russian Federation, 127473
City Clinical Hospital #5 /ID# 148318
Nizhnij Novgorod, Russian Federation, 603005
Orenburg State Medical Academy /ID# 143018
Orenburg, Russian Federation, 460000
Ryazan State Medical Universit /ID# 143031
Ryazan, Russian Federation, 390026
II Dzhan Research Center /ID# 143027
St. Petersburg, Russian Federation, 192242
NW State Med Univ NA Mechnikov /ID# 143022
St. Petersburg, Russian Federation, 193015
Republican clinical hospital n /ID# 145626
UFA, Russian Federation, 450005
Ulyanovsk Regional Clin Hosp /ID# 143030
Ulyanovsk, Russian Federation, 432018
Institute for Rheumatology /ID# 143032
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 143035
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 143036
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 143037
Belgrade, Beograd, Serbia, 11000
Special Hospital for Rheuma /ID# 143034
Novi Sad, Vojvodina, Serbia, 21101
Clinical Center of Vojvodina /ID# 143033
Novi Sad, Vojvodina, Serbia, 21137
MEDMAN s.r.o. /ID# 143045
Martin, Slovakia, 036 01
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169
Nové Mesto Nad Váhom, Slovakia, 915 01
REUMACENTRUM s.r.o. /ID# 143041
Partizanske, Slovakia, 958 01
Slovak research center Team Member, Thermium s.r.o. /ID# 147614
Pieštany, Slovakia, 921 01
Reumex, s.r.o. /ID# 143043
Rimavska Sobota, Slovakia, 97 101
Reumatologicka ambulancia /ID# 144873
Sabinov, Slovakia, 083 01
TIMMED spol. s r.o. /ID# 144872
Stará Lubovna, Slovakia, 06401
Reumatologicka ambulancia, LER /ID# 143044
Topolcany, Slovakia, 955 01
ALBAMED s.r.o. /ID# 143042
Zvolen, Slovakia, 960 01
South Africa
Greenacres Hospital /ID# 144710
Port Elizabeth, Eastern Cape, South Africa, 6045
Wits Clinical Research Site /ID# 148320
Johannesburg, Gauteng, South Africa, 2193
University of Pretoria /ID# 148353
Pretoria, Gauteng, South Africa, 0001
Jakaranda Hosp, Emmed Research /ID# 143046
Pretoria, Gauteng, South Africa, 0132
Jakaranda Hosp, Emmed Research /ID# 145968
Pretoria, Gauteng, South Africa, 0132
St. Augustine's Hospital /ID# 143047
Durban, Kwazulu-Natal, South Africa, 4001
Synexus Helderberg Clinical Tr /ID# 148322
Cape Town, Western Cape, South Africa, 7130
Arthritis Clinical Research Tr /ID# 144874
Cape Town, Western Cape, South Africa, 7405
Tiervlei Trial Centre /ID# 153085
Cape Town, Western Cape, South Africa, 7530
Winelands Medical Research Ctr /ID# 143048
Stellenbosch, Western Cape, South Africa, 7600
H. Un. Marques de Valdecilla /ID# 143050
Santander, Cantabria, Spain, 39008
Comple Hosp Univ de A Coruna /ID# 143051
A Coruna, Spain, 15006
Hospital Universitario Reina S /ID# 153566
Cordoba, Spain, 14004
Clinica Gaias /ID# 143052
Santiago de Compostela, Spain, 15702
Complejo Hosp Santiago /ID# 153727
Santiago de Compostela, Spain, 15706
China Medical University Hosp /ID# 143058
Taichung City, Taichung, Taiwan, 40447
National Taiwan Univ Hosp /ID# 143056
Taipei City, Taipei, Taiwan, 10002
Kaohsiung Medical University /ID# 143059
Kaohsiung, Taiwan, 80708
Kaohsiung Chang Gung Memorial Hospital /ID# 143055
Kaohsiung, Taiwan, 833
Far Eastern Memorial Hospital /ID# 143061
New Taipei City, Taiwan, 22060
Chung Shan Medical University /ID# 143060
Taichung City, Taiwan, 40201
Taipei Veterans General Hosp /ID# 157940
Taipei City, Taiwan, 11217
Linkou Chang Gung Memorial Ho /ID# 143057
Taoyuan City, Taiwan, 33305
Istanbul Universitesi Cerrahpa /ID# 156088
Cerrahpasa, Turkey, 34098
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063
Istanbul, Turkey, 34147
Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062
Izmir, Turkey, 35360
LLC Revmocentr /ID# 143067
Kiev, Kyiv, Ukraine, 04070
Lviv Regional Clinical Hospita /ID# 154450
Lviv, Lvivska Oblast, Ukraine, 79013
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071
Vinnytsia, Vinnytska Oblast, Ukraine, 21018
Regional Clinical Hospital /ID# 152025
Ivano-frankivsk, Ukraine, 76018
NSC-Strazhesko Ist Cardiology /ID# 152030
Kiev, Ukraine, 03680
Lviv Municipal City Clinical /ID# 143068
Lviv, Ukraine, 79007
Odessa National Medical Univ /ID# 143072
Odesa, Ukraine, 65026
Zaporizhzhia Regional Clinical /ID# 143069
Zaporizhia, Ukraine, 69600
United Kingdom
The Royal Free Hospital /ID# 143074
London, London, City Of, United Kingdom, NW3 2QG
Queen Alexandra Hospital /ID# 143077
Portsmouth, United Kingdom, PO6 3LY
Warrington + Halton Hosp NHS /ID# 143075
Warrington, United Kingdom, WA5 1LZ
Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie Identifier: NCT02629159     History of Changes
Other Study ID Numbers: M14-465
2015-003333-95 ( EudraCT Number )
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.

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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

Keywords provided by AbbVie:
Musculoskeletal disease
Joint disease
Anti-inflammatory agents
Antirheumatic agents

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Janus Kinase Inhibitors
Protein Kinase Inhibitors