Effects of Abatacept in Patients With Early Rheumatoid Arthritis (AVERT-2)

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Methotrexate; Drug: Abatacept; Other: Abatacept Placebo; Other: Methotrexate Placebo

Detailed Description

Subcutaneous (SC)

• Study Type: Interventional
• Enrollment (Actual): 994
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1428
    • Instituto de Rehabilitacion Psicofisica
  • Cordoba, Argentina, 5016
    • Hospital Privado-Centro Medico De Cordoba S.A.
  • Cordoba, Argentina, 5004
    • Centro Consultora Integral de Salud SRL
  • Tucuman, Argentina, 4000
    • Centro de Investigaciones Reumatologicas
  • Tucuman, Argentina, 4000
    • Centro Medico Privado de Reumatologia
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1015
      • Organizacion Medica De Investigacion S.A. (Omi)
    • Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
      • Local Institution
    • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1221
      • Hospital General De Agudos J.M. Ramos Mejia
    • La Plata, Buenos Aires, Argentina, 1902
      • Framingham Centro Médico
    • San Fernando, Buenos Aires, Argentina, 1646
      • Instituto de Asistencia Reumatologica Integral
  • Santa FE
    • Rosario, Santa FE, Argentina, 2000
      • CAICI
• Australia
  • Coffs Harbour, Australia, 2450
    • Local Institution
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Local Institution
    • Southport, Queensland, Australia, 4215
      • Local Institution
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Local Institution
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Local Institution
• Austria
  • Wien, Austria, 1100
    • Rheuma Zentrum Favoriten
• Brazil
  • Sao Paulo, Brazil, 04032-060
    • Local Institution
  • Sao Paulo, Brazil, 04266-010
    • Local Institution
  • Sao Paulo, Brazil, 01228-200
    • Local Institution
  • Minas Gerais
    • Juiz De Fora, Minas Gerais, Brazil, 36010-570
      • Local Institution
    • Varginha, Minas Gerais, Brazil, 37006-710
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80030-110
      • Local Institution
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
      • Local Institution
  • SAO Paulo
    • Santo Andre, SAO Paulo, Brazil, 09060-870
      • Local Institution
• Canada
  • Saskatchewan, Canada, S7K 0H6
    • Local Institution
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Local Institution
    • Trois-rivieres, Quebec, Canada, G8Z 1Y2
      • Centre De Recherche Musculo-Squelettique
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4790928
      • Centro Medico de Reumatologia Limitada
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7510586
      • SOMEAL
    • Santiago De Chile, Metropolitana, Chile, 7501126
      • Centro de Estudios Reumatologicos
• Colombia
  • Bogota, Colombia
    • Fundacion Instituto de Reumatologia Fernando Chalem
  • Bogota, Colombia
    • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
  • Cali, Colombia
    • Clinica de Artritis Temprana
  • Medellin, Colombia, MEDELLIN
    • Hospital Pablo Tobon Uribe
• Czechia
  • Plzen-Bory, Czechia, 305 99
    • Oddeleni klinicke farmakologie
  • Praha 2, Czechia, 128 50
    • Revmatologicky ustav
  • Uherske Hradiste, Czechia, 686 01
    • Medical Plus, S.R.O.
  • Zlin, Czechia, 760 01
    • PV Medical Services, s.r.o.
• Finland
  • Hyvinkaa, Finland, 05800
    • Local Institution
  • Kuopio, Finland, 70110
    • Local Institution
• France
  • Lyon Cedex 03, France, 69437
    • Local Institution
  • Orleans cedex 2, France, 45067
    • Local Institution
  • Poitiers, France, 86021
    • Local Institution
  • Toulouse cedex 9, France, 31059
    • Local Institution
• Germany
  • Aachen, Germany, 52064
    • Rheumapraxis Dr. Kurthen
  • Berlin, Germany, 14059
    • Schlosspark-Klinik
  • Berlin, Germany, 10117
    • Charité Campus Mitte
  • Berlin, Germany, 13055
    • Rheumatologische Schwerpunktpraxis Dr. Zinke
  • Berlin, Germany, 13125
    • Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch
  • Burghausen, Germany, 84489
    • Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken
  • Freiburg, Germany, 79106
    • Klinikum Der Albrecht-Ludwigs-Universitat
  • Hamburg, Germany, 20095
    • MVZ Rheuma
  • Hamburg, Germany, 22391
    • Hamburger Rheuma Forschungszentrum
  • Hildesheim, Germany, 31134
    • Gemeinschaftspraxis Drs. von Hinueber u Demary
  • Planegg, Germany, 82152
    • Rheumatologie In Wuermtal
  • Rendsburg, Germany, 24768
    • Praxis Dr. Walter
• Hungary
  • Budapest, Hungary, 1027
    • Local Institution
  • Debrecen, Hungary, 4032
    • Belgyogy. Int. Reuma. DEOEC
  • Esztergom, Hungary, 2500
    • Vaszary Kolos Hospital
  • Kistarcsa, Hungary, 2143
    • Reumatologiai Osztaly Flor F.
  • Szolnok, Hungary, 5000
    • Reumatologiai Osztaly MAV
  • Veszprem, Hungary, 8200
    • Vital Medical Center
• Israel
  • Haifa, Israel, 31096
    • Local Institution
  • Petach Tikva, Israel, 4941492
    • Local Institution
  • Ramat-gan, Israel, 52621
    • Local Institution
  • Tel Hashomer, Israel, 52620
    • Local Institution
  • Zrifin, Israel
    • Local Institution
• Italy
  • Catania, Italy, 95123
    • Ospedale Vittorio Emanuele
  • Milano, Italy, 20154
    • Azienda Ospedaliera Luigi Sacco
  • Milano, Italy, 20122
    • Istituto Gaetano Pini
  • Pavia, Italy, 27100
    • Local Institution
  • Roma, Italy, 00168
    • Local Institution
  • Verona, Italy, 37134
    • Ospedale Borgo Roma
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 4668560
      • Local Institution
    • Nagoya-shi, Aichi, Japan, 4578511
      • Local Institution
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 8108563
      • Local Institution
    • Kitakyushu-shi, Fukuoka, Japan, 8078556
      • Local Institution
  • Hiroshima
    • Hiroshima-Shi, Hiroshima, Japan, 7348551
      • Local Institution
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 0608604
      • Local Institution
    • Sapporo-shi, Hokkaido, Japan, 0608648
      • Local Institution
    • Sapporo-shi, Hokkaido, Japan, 0630811
      • Local Institution
  • Hyogo
    • Kato-shi, Hyogo, Japan, 6731462
      • Local Institution
  • Ibaraki
    • Hitachinaka-shi, Ibaraki, Japan, 3120057
      • Local Institution
    • Mito-shi, Ibaraki, Japan, 3100015
      • Local Institution
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 8900063
      • Local Institution
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 2520392
      • Local Institution
  • Nagasaki
    • Isahaya-shi, Nagasaki, Japan, 8548501
      • Local Institution
    • Sasebo-shi, Nagasaki, Japan, 8571195
      • Local Institution
  • Okinawa
    • Tomigusuku-shi, Okinawa, Japan, 9010224
      • Local Institution
  • Osaka
    • Izumisano-shi, Osaka, Japan, 5988577
      • Local Institution
    • Kawachinagano, Osaka, Japan, 5868521
      • Local Institution
  • Saitama
    • Iruma-gun, Saitama, Japan, 3500495
      • Local Institution
    • Kawagoe-shi, Saitama, Japan, 3508550
      • Local Institution
    • Sayama-shi, Saitama, Japan, 3501305
      • Local Institution
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 4308558
      • Local Institution
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1048560
      • Local Institution
    • Itabashi-ku, Tokyo, Japan, 1738610
      • Local Institution
    • Meguro-ku, Tokyo, Japan, 1538515
      • Local Institution
    • Meguro-ku, Tokyo, Japan, 1528902
      • Local Institution
    • Shinjuku-Ku, Tokyo, Japan, 1608582
      • Local Institution
• Korea, Republic of
  • Seoul, Korea, Republic of, 04763
    • Local Institution
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
      • Local Institution
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Local Institution
• Mexico
  • Guadalajara, Mexico
    • Local Institution
  • México D.F., Mexico
    • Local Institution
  • San Luis Potosi, Mexico, 78213
    • Local Institution
  • Baja California
    • Mexicali, Baja California, Mexico
      • Local Institution
  • Distrito Fededral
    • Mexico City, Distrito Fededral, Mexico, 11850
      • Local Institution
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 44280
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 44600
      • Local Institution
• Monaco
  • Monaco, Monaco, 98012
    • Local Institution
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Local Institution
• Peru
  • Lima, Peru, LIMA 27
    • Clínica El Golf
  • Lima, Peru, 27
    • Local Institution
  • Lima, Peru, LIMA 33
    • Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
  • Lima, Peru, LIMA 11
    • Acq Medic Sac
• Poland
  • Dabrowka, Poland, 62-069
    • NSZOZ Unica CR
  • Nadarzyn, Poland, 05-830
    • Nzoz Mak Med
  • Stalowa Wola, Poland, 37-450
    • SANUS Szpital Specjalistyczny Sp. z o.o.
  • Staszow, Poland, 28-200
    • Local Institution
  • Ustron, Poland, 43-450
    • Slaski Szpital Reumatologiczno - Rehabilitacyjny
  • Warszawa, Poland, 02637
    • Instytut Reumatologii, I Klinika Reumatologii
  • Warszawa, Poland, 03-291
    • Centrum Medyczne AMED Sp. z o.o.
• Qatar
  • Doha, Qatar
    • Local Institution
• Romania
  • Bucharest, Romania, 011192
    • Local Institution
  • Bucuresti, Romania, 020983
    • Local Institution
  • Cluj-napoca, Romania, 400006
    • Local Institution
• Russian Federation
  • Ekaterinburg, Russian Federation, 620102
    • Local Institution
  • Moscow, Russian Federation, 119049
    • Local Institution
  • St Petersburg, Russian Federation, 191124
    • Local Institution
  • St.petersburg, Russian Federation, 197022
    • Local Institution
  • Yaroslavl, Russian Federation, 150003
    • Local Institution
• Singapore
  • Singapore, Singapore, 169856
    • Local Institution
  • Singapore, Singapore, 117549
    • Local Institution
• South Africa
  • Eastern CAPE
    • Port Elizabeth, Eastern CAPE, South Africa, 6045
      • Local Institution
  • Gauteng
    • Soweto, Gauteng, South Africa, 2013
      • Local Institution
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7500
      • Local Institution
  • Western Cape
    • Pinelands, Cape Town, Western Cape, South Africa, 7405
      • Local Institution
    • Stellenbosch, Western Cape, South Africa, 7600
      • Local Institution
• Spain
  • A Coruna, Spain, 15006
    • Local Institution
  • Barcelona, Spain, 08036
    • Local Institution
  • Madrid, Spain, 28006
    • Local Institution
  • Madrid, Spain, 28046
    • Local Institution
  • Santiago Compostela, Spain, 15702
    • Local Institution
• Sweden
  • Goteborg, Sweden, 413 45
    • Local Institution
  • Malmo, Sweden, 205 02
    • Local Institution
  • Stockholm, Sweden, 171 76
    • Local Institution
  • Uppsala, Sweden, 751 85
    • Local Institution
• Taiwan
  • Tainan, Taiwan, 704
    • Local Institution
  • Taipei, Taiwan, 100
    • Local Institution
  • Taipei, Taiwan, 112
    • Local Institution
  • Taoyuan, Taiwan, 333
    • Local Institution
• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Local Institution
  • Manchester, United Kingdom, M13 9WL
    • Local Institution
  • North Yorkshire
    • Leeds, North Yorkshire, United Kingdom, LS7 4SA
      • Local Institution
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Rheumatology Associates Of North Alabama, P.C.
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Research PLLC
    • Mesa, Arizona, United States, 85210
      • Arizona Arthritis & Rheumatology Research PLLC
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis & Rheumatology Research PLLC
    • Phoenix, Arizona, United States, 85032
      • Arizona Arthritis & Rheumatology Research PLLC
    • Sun City, Arizona, United States, 85351
      • Arizona Arthritis & Rheumatology Research PLLC
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • CHI St. Vincent Medical Group Hot Springs
    • Little Rock, Arkansas, United States, 72204
      • Arkansas Primary Care Clinic
  • California
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Medical Group
    • Huntington Beach, California, United States, 92646
      • HealthCare Partners Medical Group
    • Los Alamitos, California, United States, 90720
      • Valerius Medical Group and Research Center
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials Inc.
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Joao Nascimento
  • Florida
    • Orlando, Florida, United States, 32806
      • Rheumatology Associates of Central Florida, P.A.
    • Tampa, Florida, United States, 33614
      • Tampa Medical Group, Pa
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Coeur D'Alene Arthrit Clin
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Arthritis and Diabetes Clinic
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Klein And Associates, M.D., Pa
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • St. Paul Rheumatology, P.A.
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Arthritis Consultants
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Arthritis And Osteoporosis Associates, Pa
    • Toms River, New Jersey, United States, 08755
      • Physicians Research Center, Llc
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center for Rheumatology
  • New York
    • New York, New York, United States, 10021-4892
      • Hospital for Special Surgery
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Local Institution
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
    • Wilmington, North Carolina, United States, 28401
      • Pmg Research Of Wilmington Llc
    • Wilmington, North Carolina, United States, 28401
      • Carolina Arthritis Associates
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Ctr For Arthritis Therapy And Research, Inc.
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Philadelphia, Pennsylvania, United States, 19152
      • The Arthritis Group
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLP
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
  • Texas
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Houston, Texas, United States, 77074
      • Houston Institute For Clinical Research
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Arthritis Clinic Of Northern Virginia, P.C.
    • Danville, Virginia, United States, 24541
      • Spectrum Medical, Inc.
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest
  • Wisconsin
    • Glendale, Wisconsin, United States, 53217
      • Rheumatic Disease Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Rheumatoid arthritis (RA) diagnosis less than 6 months
• CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
• At least 3 swollen and 3 tender joints
• Anti-citrullinated protein antibodies (ACPA) positive

Exclusion Criteria:

• At risk for tuberculosis
• Have acute infection
• Have chronic or recurrent bacterial or serious latent viral infection
• History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
• Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Therapy: Abatacept + Methotrexate; Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week	Drug: Methotrexate; Drug: Abatacept
Active Comparator: Methotrexate treatment; Methotrexate at least 15mg per week tablet or capsule orally	Drug: Methotrexate
Placebo Comparator: Abatacept Placebo; Placebo for Abatacept subcutaneous injection once per week	Other: Abatacept Placebo
Placebo Comparator: Methotrexate Placebo; Placebo to match Methotrexate capsule orally once per week	Other: Methotrexate Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24	Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24	DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.	Week 24
Percentage of Participants in SDAI Remission at Week 52	Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.	Week 52
Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52	The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.	Week 52
Percentage of Participants in Boolean Remission at Week 52	Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.	Week 52

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2015
• Primary Completion (Actual): January 16, 2017
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Immune Checkpoint Inhibitors; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate; Abatacept
• Other Study ID Numbers: IM101-550; 2015-001275-50 (EudraCT Number)