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Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Abatacept (Drug); Methotrexate (Drug); Abatacept placebo (Drug); Methotrexate placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

Clinical Details

Official title: A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18

Secondary outcome:

Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18

Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time

Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18

Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18

Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time

Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time

Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response Over Time

Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical and Mental Component Summary Scores of Short Form-36 (SF-36)

Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period

Adverse Events (AEs) of Interest During the Treatment Period

Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Key Inclusion Criteria:

- Presence of active clinical synovitis in at least 2 joints, 1 of which must have been

a small joint, for a minimum of 8 weeks prior to screening

- Onset of persistent symptoms ≤ 2 years prior to screening

- Positive test result for anticyclic citrullinated peptides 2

- Methotrexate naive or with minimum exposure to methotrexate, defined as no more than

10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit

- Biologic naive, including no treatment with an investigational biologic prior to


- Disease Activity Score 28 based on C-reactive protein score ≥3. 2 at screening

- Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or

sulfasalazine (wash-out) for a minimum of 28 days prior to randomization

- If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone

equivalent) for at least 4 weeks

- Able to undergo magnetic resonance imaging

Key Exclusion Criteria:

- Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)

- Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within

4 weeks prior to randomization

- Scheduled for or anticipating joint replacement surgery

- Presence of concomitant illness likely to require systemic glucocorticosteroid

therapy during the study, in the opinion of the investigator

- History of malignancy in the last 5 years

- Any serious bacterial infection within the last 3 months not treated or resolved with

antibiotics, or any chronic or recurrent bacterial infection

- At risk for tuberculosis

- Evidence of active or latent bacterial or viral infection at the time of potential

enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment

Locations and Contacts

Local Institution, Bruxelles 1200, Belgium

Local Institution, Kortrijk 8500, Belgium

Local Institution, Merksem 2170, Belgium

Local Institution, Hjorring 9800, Denmark

Local Institution, Helsinki 00290, Finland

Local Institution, Tampere 33521, Finland

Local Institution, Chambray Les Tours 37170, France

Local Institution, Montpellier 34295, France

Local Institution, Paris Cedex 14 75679, France

Local Institution, Poitiers 86021, France

Local Institution, Berlin 10117, Germany

Local Institution, Berlin 14059, Germany

Local Institution, Hildesheim 31134, Germany

Local Institution, Muenchen 80336, Germany

Local Institution, Muenchen 80639, Germany

Local Institution, Muenchen 81541, Germany

Local Institution, Ancona 60055, Italy

Local Institution, Siena 53100, Italy

Local Institution, Daegu 705-718, Korea, Republic of

Local Institution, Daejeon 302-799, Korea, Republic of

Local Institution, Seoul 133-791, Korea, Republic of

Local Institution, Seoul 137-701, Korea, Republic of

Local Institution, Chihuahua 31000, Mexico

Local Institution, Queretaro 76178, Mexico

Local Institution, San Luis Potosi 78240, Mexico

Local Institution, Lublin 20-954, Poland

Local Institution, Poznan 60-218, Poland

Local Institution, Torun 87100, Poland

Local Institution, Warszawa 01-868, Poland

Local Institution, Warszawa 01-157, Poland

Local Institution, Wroc#aw 50-088, Poland

Local Institution, Moscow 117049, Russian Federation

Local Institution, Moscow 129327, Russian Federation

Local Institution, Tver 170036, Russian Federation

Local Institution, Goteborg 413 45, Sweden

Local Institution, Linkoping 581 85, Sweden

Local Institution, Malmo 205 02, Sweden

Local Institution, Stockholm 171 76, Sweden

Local Institution, Uppsala 751 85, Sweden

Rheumatology Associates Of North Alabama, P.C., Huntsville, Alabama 35801, United States

Local Institution, Calgary, Alberta T2N 4N1, Canada

St. Joseph'S Mercy Clinic, Hot Springs, Arkansas 71913, United States

Local Institution, Metepec, Estado De Mexico 52140, Mexico

Sarasota Arthritis Research Center, Sarasota, Florida 34239, United States

Local Institution, Kempton Park, Gauteng 1619, South Africa

Local Institution, Pretoria, Gauteng 0181, South Africa

Local Institution, Pretoria, Gauteng 0084, South Africa

Local Institution, Pretoria, Gauteng 0083, South Africa

Coeur D'Alene Arthrit Clin, Coeur D Alene, Idaho 83814, United States

Local Institution, Guadalajara, Jalisco 44500, Mexico

Local Institution, Guadalajara, Jalisco 44690, Mexico

Local Institution, Durban, Kwa Zulu Natal 4001, South Africa

Johns Hopkins University Division Of Rheumatology, Baltimore, Maryland 21224, United States

Clinical Pharmacology Study Group, Worcester, Massachusetts 01605, United States

Arthritis Associates Of Mississippi, Jackson, Mississippi 39202, United States

Physician Research Collaboration, Llc, Lincoln, Nebraska 68516, United States

Piedmont Rheumatology, Pa, Hickory, North Carolina 28602, United States

Carolina Arthritis Associates, Wilmington, North Carolina 28401, United States

Local Institution, Monterrey, Nuevo Leon 64020, Mexico

Metrohealth Medical Center, Cleveland, Ohio 44109, United States

Isam A. Diab, Md, Middleburg, Ohio 44130, United States

Alan J. Kivitz, Md, Cpi, Duncansville, Pennsylvania 16635, United States

Local Institution, Laval, Quebec H7T 2P5, Canada

Local Institution, Cairns, Queensland 4870, Australia

Local Institution, Maroochydore, Queensland 4558, Australia

Local Institution, Woodville, South Australia 5011, Australia

Mitchell C. Feinman, Md, Orangeburg, South Carolina 29118, United States

Local Institution, Heidelberg, Victoria 3084, Australia

Local Institution, Malvern, Victoria 3144, Australia

Local Institution, Victoria Park, Western Australia 6100, Australia

Local Institution, Panorama, Western Cape 7500, South Africa

Kurt Oelke, Md, Glendale, Wisconsin 53217, United States

Local Institution, Merida, Yucatan 97000, Mexico

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: December 2010
Last updated: November 26, 2014

Page last updated: August 23, 2015

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