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Trial record 58 of 137 for:    "Connective Tissue Disease" | "Abatacept"

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

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.
ClinicalTrials.gov Identifier: NCT02504268
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Results First Posted : April 8, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Abatacept Drug: Methotrexate Other: Abatacept Placebo Other: Methotrexate Placebo Phase 3

Detailed Description:
Subcutaneous (SC)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1067 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : January 16, 2017
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine


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: Abatacept
Drug: Methotrexate
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



Primary Outcome Measures :
  1. Percentage of Subjects in Simple Disease Activity Index (SDAI) Remission at Week 24 [ Time Frame: 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.



Secondary Outcome Measures :
  1. Percentage of Subjects in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24 [ Time Frame: 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.

  2. Percentage of Subjects in SDAI Remission at Week 52 [ Time Frame: 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.

  3. 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 [ Time Frame: 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.

  4. Percentage of Subjects in Boolean Remission at Week 52 [ Time Frame: 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.



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

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)

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 ClinicalTrials.gov identifier (NCT number): NCT02504268


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Locations
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United States, Alabama
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Arthritis & Rheumatology Research PLLC
Glendale, Arizona, United States, 85306
Arizona Arthritis & Rheumatology Research PLLC
Mesa, Arizona, United States, 85210
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, United States, 85032
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, United States, 85037
Arizona Arthritis & Rheumatology Research PLLC
Sun City, Arizona, United States, 85351
United States, Arkansas
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas, United States, 71913
Arkansas Primary Care Clinic
Little Rock, Arkansas, United States, 72204
United States, California
St. Joseph Heritage Medical Group
Fullerton, California, United States, 92835
Healthcare Partners Medical Group
Huntington Beach, California, United States, 92646
Valerius Medical Group and Research Center
Los Alamitos, California, United States, 90720
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States, 91786
United States, Connecticut
Joao Nascimento
Bridgeport, Connecticut, United States, 06606
United States, Florida
Rheumatology Associates Of Central Florida, P.A.
Orlando, Florida, United States, 32806
Tampa Medical Group, Pa
Tampa, Florida, United States, 33614
United States, Idaho
Coeur D'Alene Arthrit Clin
Coeur d'Alene, Idaho, United States, 83814-2644
United States, Louisiana
Arthritis And Diabetes Clinic
Monroe, Louisiana, United States, 71203
United States, Maryland
Klein And Associates, M.D., Pa
Hagerstown, Maryland, United States, 21740
United States, Minnesota
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States, 55121
United States, Missouri
Arthritis Consultants
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Arthritis And Osteoporosis Associates, Pa
Freehold, New Jersey, United States, 07728
Physicians Research Center, Llc
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States, 87102
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States, 87102
United States, New York
Hospital For Special Surgery
New York, New York, United States, 10021-4892
United States, North Carolina
Local Institution
Hickory, North Carolina, United States, 28601
Pmg Research Of Salisbury
Salisbury, North Carolina, United States, 28144
Carolina Arthritis Associates
Wilmington, North Carolina, United States, 28401
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, United States, 28401
United States, Oklahoma
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma Ctr For Arthritis Therapy And Research, Inc.
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
The Arthritis Group
Philadelphia, Pennsylvania, United States, 19152
Clinical Research Center Of Reading, Llc
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Houston Institute For Clinical Research
Houston, Texas, United States, 77074
United States, Virginia
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States, 22205
Spectrum Medical, Inc.
Danville, Virginia, United States, 24541
United States, Washington
Arthritis Northwest
Spokane, Washington, United States, 99204
United States, Wisconsin
Rheumatic Disease Center
Glendale, Wisconsin, United States, 53217
Argentina
Organizacion Medica De Investigacion S.A. (Omi)
Capital Federal, Buenos Aires, Argentina, 1015
Local Institution
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
Hospital General De Agudos J.M. Ramos Mejia
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1221
Framingham Centro Medico
La Plata, Buenos Aires, Argentina, 1902
Instituto de Asistencia Reumatologica Integral
San Fernando, Buenos Aires, Argentina, 1646
Caici
Rosario, Santa FE, Argentina, 2000
Instituto De Rehabilitacion Psicofisica
Buenos Aires, Argentina, 1428
Centro Consultora Integral de Salud SRL
Cordoba, Argentina, 5004
Hospital Privado-Centro Medico De Cordoba S.A.
Cordoba, Argentina, 5016
Centro De Investigaciones Reumatologicas
Tucuman, Argentina, 4000
Centro Medico Privado De Reumatologia
Tucuman, Argentina, 4000
Australia, Queensland
Local Institution
Maroochydore, Queensland, Australia, 4558
Local Institution
Southport, Queensland, Australia, 4215
Australia, Tasmania
Local Institution
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Local Institution
Camberwell, Victoria, Australia, 3124
Australia
Local Institution
Coffs Harbour, Australia, 2450
Austria
Rheuma Zentrum Favoriten
Wien, Austria, 1100
Brazil
Local Institution
Juiz De Fora, Minas Gerais, Brazil, 36010-570
Local Institution
Varginha, Minas Gerais, Brazil, 37006-710
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Curitiba, Parana, Brazil, 80060-240
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Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Local Institution
Santo Andre, SAO Paulo, Brazil, 09060-870
Local Institution
Sao Paulo, Brazil, 01228-200
Local Institution
Sao Paulo, Brazil, 04032-060
Local Institution
Sao Paulo, Brazil, 04266-010
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2L 1S6
Centre De Recherche Musculo-Squelettique
Trois-rivieres, Quebec, Canada, G8Z 1Y2
Canada
Local Institution
Saskatchewan, Canada, S7K 0H6
Chile
Centro Medico de Reumatologia Limitada
Temuco, Araucania, Chile, 4790928
Centro De Estudios Reumatologicos
Santiago De Chile, Metropolitana, Chile, 7501126
Someal
Santiago, Metropolitana, Chile, 7510586
Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
Bogota, Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota, Colombia
Clinica de Artritis Temprana
Cali, Colombia
Hospital Pablo Tobon Uribe
Medellin, Colombia, MEDELLIN
Czechia
Oddeleni klinicke farmakologie
Plzen-Bory, Czechia, 305 99
Revmatologicky ustav
Praha 2, Czechia, 128 50
MEDICAL PLUS, s.r.o.
Uherske Hradiste, Czechia, 686 01
PV Medical Services, s.r.o.
Zlin, Czechia, 760 01
Finland
Local Institution
Hyvinkaa, Finland, 05800
Local Institution
Kuopio, Finland, 70110
France
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Lyon Cedex 03, France, 69437
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Orleans cedex 2, France, 45067
Local Institution
Poitiers, France, 86021
Local Institution
Toulouse cedex 9, France, 31059
Germany
Rheumapraxis Dr. Kurthen
Aachen, Germany, 52064
Charite Campus Mitte
Berlin, Germany, 10117
Rheumatologische Schwerpunktpraxis Dr. Zinke
Berlin, Germany, 13055
Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch
Berlin, Germany, 13125
Schlosspark-Klinik
Berlin, Germany, 14059
Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken
Burghausen, Germany, 84489
Klinikum Der Albrecht-Ludwigs-Universitat
Freiburg, Germany, 79106
MVZ Rheuma
Hamburg, Germany, 20095
Hamburger Rheuma Forschungszentrum
Hamburg, Germany, 22391
Gemeinschaftspraxis Drs. von Hinueber u Demary
Hildesheim, Germany, 31134
Rheumatologie In Wuermtal
Planegg, Germany, 82152
Praxis Dr. Walter
Rendsburg, Germany, 24768
Hungary
Local Institution
Budapest, Hungary, 1027
Belgyogy. Int. Reuma. DEOEC
Debrecen, Hungary, 4032
Vaszary Kolos Hospital
Esztergom, Hungary, 2500
Reumatologiai Osztaly Flor F.
Kistarcsa, Hungary, 2143
Reumatologiai Osztaly MAV
Szolnok, Hungary, 5000
Vital Medical Center
Veszprem, Hungary, 8200
Israel
Local Institution
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
Italy
Ospedale Vittorio Emanuele
Catania, Italy, 95123
Istituto Gaetano Pini
Milano, Italy, 20122
Azienda Ospedaliera Luigi Sacco
Milano, Italy, 20154
Local Institution
Pavia, Italy, 27100
Local Institution
Roma, Italy, 00168
Ospedale Borgo Roma
Verona, Italy, 37134
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4578511
Local Institution
Nagoya-shi, Aichi, Japan, 4668560
Local Institution
Fukuoka-shi, Fukuoka, Japan, 8108563
Local Institution
Kitakyushu-shi, Fukuoka, Japan, 8078555
Local Institution
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608604
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Sapporo-shi, Hokkaido, Japan, 0630811
Local Institution
Kato-shi, Hyogo, Japan, 6731462
Local Institution
Hitachinaka-shi, Ibaraki, Japan, 3120057
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Mito-shi, Ibaraki, Japan, 3100015
Local Institution
Kagoshima-shi, Kagoshima, Japan, 8900063
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Sagamihara-shi, Kanagawa, Japan, 2520392
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Isahaya-shi, Nagasaki, Japan, 8548501
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Sasebo-shi, Nagasaki, Japan, 8571195
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Tomigusuku-shi, Okinawa, Japan, 9010243
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Izumisano-shi, Osaka, Japan, 5988577
Local Institution
Kawachinagano, Osaka, Japan, 5868521
Local Institution
Iruma-gun, Saitama, Japan, 3500495
Local Institution
Kawagoe-shi, Saitama, Japan, 3508550
Local Institution
Sayama-shi, Saitama, Japan, 3501305
Local Institution
Hamamatsu-shi, Shizuoka, Japan, 4308558
Local Institution
Chuo-ku, Tokyo, Japan, 1048560
Local Institution
Itabashi-ku, Tokyo, Japan, 1738610
Local Institution
Meguro-ku, Tokyo, Japan, 1528902
Local Institution
Meguro-ku, Tokyo, Japan, 1538515
Local Institution
Shinjuku-Ku, Tokyo, Japan, 1608582
Korea, Republic of
Local Institution
Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
Local Institution
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Local Institution
Seoul, Korea, Republic of, 04763
Mexico
Local Institution
Mexicali, BAJA California, Mexico
Local Institution
Mexico City, Distrito Fededral, Mexico, 11850
Local Institution
Leon, Guanajuato, Mexico, 37000
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Local Institution
Guadalajara, Jalisco, Mexico, 44600
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Mexico
Local Institution
Mexico D.F., Mexico
Local Institution
San Luis Potosi, Mexico, 78213
Monaco
Local Institution
Monaco, Monaco, 98012
Netherlands
Local Institution
Leiden, Netherlands, 2333 ZA
Peru
Local Institution
Lima, Peru, 27
Acq Medic Sac
Lima, Peru, LIMA 11
Clinica El Golf
Lima, Peru, Lima 27
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, Peru, LIMA 33
Poland
Nszoz Unica Cr
Dabrowka, Poland, 62-069
Local Institution
Elblag, Poland, 82-300
Nzoz Mak Med
Nadarzyn, Poland, 05-830
SANUS Szpital Specjalistyczny Sp. z o.o.
Stalowa Wola, Poland, 37-450
Local Institution
Staszow, Poland, 28-200
Slaski Szpital Reumatologiczno - Rehabilitacyjny
Ustron, Poland, 43-450
Instytut Reumatologii, I Klinika Reumatologii
Warszawa, Poland, 02637
Amed Medical Center
Warszawa, Poland, 03-291
Qatar
Local Institution
Doha, Qatar
Romania
Local Institution
Bucharest, Romania, 011192
Local Institution
Bucuresti, Romania, 020983
Local Institution
Cluj-napoca, Romania, 400006
Russian Federation
Local Institution
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
Singapore
Local Institution
Singapore, Singapore, 117549
Local Institution
Singapore, Singapore, 169856
South Africa
Local Institution
Port Elizabeth, Eastern CAPE, South Africa, 6045
Local Institution
Soweto, Gauteng, South Africa, 2013
Local Institution
Cape Town, Western CAPE, South Africa, 7500
Local Institution
Pinelands, Cape Town, Western CAPE, South Africa, 7405
Local Institution
Stellenbosch, Western CAPE, South Africa, 7600
Spain
Local Institution
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
Sweden
Local Institution
Goteborg, Sweden, 413 45
Local Institution
Malmo, Sweden, 205 02
Local Institution
Stockholm, Sweden, 171 76
Local Institution
Uppsala, Sweden, 751 85
Taiwan
Local Institution
Tainan, Taiwan, 704
Local Institution
Taipei, Taiwan, 100
Local Institution
Taipei, Taiwan, 112
Local Institution
Taoyuan, Taiwan, 333
United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom, M13 9WL
Local Institution
Leeds, North Yorkshire, United Kingdom, LS7 4SA
Local Institution
Hull, United Kingdom, HU3 2JZ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02504268     History of Changes
Other Study ID Numbers: IM101-550
2015-001275-50 ( EudraCT Number )
First Posted: July 21, 2015    Key Record Dates
Results First Posted: April 8, 2019
Last Update Posted: August 6, 2019
Last Verified: August 2019

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