Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination With Methotrexate in Adults With Very Early Rheumatoid Arthritis (RA)

Condition(s) targeted: Rheumatoid Arthritis

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

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

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

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

The primary purpose of the protocol is to show that Abatacept can induce remission after 12 months of treatment and then maintained remission following 6 months of drug withdrawal.

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:

The proportion of subjects in remission as defined by the Disease Activity Score (DAS)

The proportion of subjects in remission as defined by the Disease Activity Score (DAS)

Secondary outcome:

Outcomes research assessments for physical function will be measured using the HAQ questionnaire and health-related quality of life will be measured using the SF-36 questionnaire

Outcomes research assessments for physical function will be measured using the Health Assessment Questionaire (HAQ) and health-related quality of life will be measured using the SF-36 questionnaire

Outcomes research assessments for physical function will be measured using the HAQ and health-related quality of life will be measured using the SF-36 questionnaire

Outcomes research assessments for physical function will be measured using the HAQ and health-related quality of life will be measured using the SF-36 questionnaire

Joint damage progression (MRI)

Joint damage progression (MRI)

Joint damage progression (MRI)

Joint damage progression (MRI)

Adverse Event rates

Adverse Event rates

Adverse Event rates

Adverse Event rates

Proportion of subjects in the Abatacept monotherapy arm in remission as defined by the Disease Activity Score (DAS)

Proportion of subjects in the Abatacept monotherapy arm in remission as defined by the Disease Activity Score (DAS)

Proportion of subjects in the Abatacept monotherapy arm in remission as defined by the Disease Activity Score (DAS)

Proportion of subjects in the Abatacept monotherapy arm in remission as defined by the Disease Activity Score (DAS)

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

Criteria:

Inclusion Criteria:

- Active clinical synovitis (≥ 2 joints; ≥8 weeks)

- Onset of persistent symptoms ≤ 2 years

- Anti cyclic citrullinated peptides (CCP) 2 Positive

- Methotrexate (MTX) and Biologic naive

- DAS28 C-reactive protein (CRP) ≥ 3. 2

- Must be able to receive an MRI

Exclusion Criteria:

- Subjects who met criteria for other rheumatic disease (eg, lupus, erythematosus)

- History of active or chronic hepatitis

- Cancer in the last 5 years

- History of severe chronic or recurrent bacterial or viral infections

- Risk of tuberculosis

- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic,

Gastrointestinal (GI), pulmonary, cardiac, neurologic, or cerebral disease

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Bruxelles 1200, Belgium; Recruiting
Site 016

Local Institution, Kortrijk 8500, Belgium; Recruiting
Site 015

Local Institution, Merksem 2170, Belgium; Recruiting
Site 014

Local Institution, Hjorring 9800, Denmark; Recruiting
Site 047

Local Institution, Helsinki 00290, Finland; Recruiting
Site 031

Local Institution, Tampere 33521, Finland; Recruiting
Site 112

Local Institution, Chambray Les Tours 37170, France; Recruiting
Site 048

Local Institution, Montpellier 34295, France; Recruiting
Site 059

Local Institution, Paris Cedex 14 75679, France; Recruiting
Site 050

Local Institution, Poitiers 86021, France; Recruiting
Site 049

Local Institution, Berlin 10117, Germany; Recruiting
Site 041

Local Institution, Berlin 14059, Germany; Recruiting
Site 043

Local Institution, Hildesheim 31134, Germany; Recruiting
Site 040

Local Institution, Muenchen 80336, Germany; Recruiting
Site 115

Local Institution, Muenchen 80639, Germany; Recruiting
Site 039

Local Institution, Muenchen 81541, Germany; Recruiting
Site 042

Local Institution, Ancona 60055, Italy; Recruiting
Site 038

Local Institution, Bari 70124, Italy; Not yet recruiting
Site 020

Local Institution, Siena 53100, Italy; Recruiting
Site 018

Local Institution, Daegu 705718, Korea, Republic of; Recruiting
Site 110

Local Institution, Daejeon 302-799, Korea, Republic of; Recruiting
Site 109

Local Institution, Seoul 137-701, Korea, Republic of; Recruiting
Site 108

Local Institution, Chihuahua 31000, Mexico; Not yet recruiting
Site 101

Local Institution, Queretaro 76178, Mexico; Recruiting
Site 057

Local Institution, San Luis Potosi 78240, Mexico; Recruiting
Site 053

Local Institution, Lublin 20-954, Poland; Recruiting
Site 093

Local Institution, Poznan 60-218, Poland; Recruiting
Site 092

Local Institution, Torun 87100, Poland; Recruiting
Site 099

Local Institution, Warszawa 01-868, Poland; Recruiting
Site 114

Local Institution, Warszawa 01-157, Poland; Recruiting
Site 091

Local Institution, Wroc#Aw 50-088, Poland; Recruiting
Site 095

Local Institution, Goteborg 413 45, Sweden; Recruiting
Site 063

Local Institution, Linkoping 581 85, Sweden; Recruiting
Site 061

Local Institution, Malmo 205 02, Sweden; Recruiting
Site 060

Local Institution, Stockholm 171 76, Sweden; Recruiting
Site 064

Local Institution, Uppsala 751 85, Sweden; Recruiting
Site 062

Rheumatology Associates Of N. Al, P.C., Huntsville, Alabama 35801, United States; Active, not recruiting

Local Institution, Calgary, Alberta T2N 4N1, Canada; Recruiting
Site 104

Melody D. St. John, Md, Hot Springs, Arkansas 71913, United States; Active, not recruiting

New England Research Associates, Llc, Trumbull, Connecticut 06611, United States; Active, not recruiting

Local Institution, Metepec, Estado De Mexico 52140, Mexico; Recruiting
Site 055

Jeffrey Kaine, Md, Sarasota, Florida 34239, United States; Active, not recruiting

Local Institution, Kempton Park, Gauteng 1619, South Africa; Recruiting
Site 037

Local Institution, Pretoria, Gauteng 0083, South Africa; Recruiting
Site 036

Local Institution, Pretoria, Gauteng 0084, South Africa; Recruiting
Site 035

Local Institution, Pretoria, Gauteng 0181, South Africa; Recruiting
Site 034

Coeur D'Alene Arthrit Clin, Coeur D Alene, Idaho 83814, United States; Active, not recruiting

Local Institution, Guadalajara, Jalisco 44500, Mexico; Recruiting
Site 102

Local Institution, Guadalajara, Jalisco 44690, Mexico; Recruiting
Site 054

Local Institution, Durban, Kwa Zulu Natal 4001, South Africa; Recruiting
Site 032

Johns Hopkins University Division Of Rheumatology, Baltimore, Maryland 21224, United States; Active, not recruiting

Clinical Pharmacology Study Group, Worcester, Massachusetts 01605, United States; Active, not recruiting

Neal I. Shparago, D. O., Jackson, Mississippi 39202, United States; Active, not recruiting

Robert M. Valente, M.D., Lincoln, Nebraska 68516, United States; Active, not recruiting

Piedmont Rheumatology, Pa, Hickory, North Carolina 28602, United States; Active, not recruiting

Carolina Arthritis Associates, Wilmington, North Carolina 28401, United States; Active, not recruiting

Local Institution, Monterrey, Nuevo Leon 64020, Mexico; Recruiting
Site 056

Metrohealth Medical Center, Cleveland, Ohio 44109, United States; Active, not recruiting

Isam A. Diab, Md, Middleburg, Ohio 44130, United States; Active, not recruiting

Local Institution, Hamilton, Ontario L8N 1Y2, Canada; Not yet recruiting
Site 116

Local Institution, Kitchener, Ontario N2M 5N6, Canada; Active, not recruiting

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

Local Institution, Laval, Quebec H7T 2P5, Canada; Recruiting
Site 113

Local Institution, Cairns, Queensland 4870, Australia; Recruiting
Site 004

Local Institution, Maroochydore, Queensland 4558, Australia; Recruiting
Site 002

Local Institution, Woodville, South Australia 5011, Australia; Recruiting
Site 008

Mitchell C. Feinman, Md, Orangeburg, South Carolina 29118, United States; Active, not recruiting

Local Institution, Seoul, Sungdong-Gu 133-792, Korea, Republic of; Recruiting
Site 107

Rheumatology Consultants Pllc, Knoxville, Tennessee 37909, United States; Completed

Local Institution, Heidelberg, Victoria 3081, Australia; Recruiting
Site 003

Local Institution, Malvern, Victoria 3144, Australia; Recruiting
Site 005

Local Institution, Victoria Park, Western Australia 6100, Australia; Recruiting
Site 009

Local Institution, Panorama, Western Cape 7500, South Africa; Recruiting
Site 033

Kurt Oelke, Md, Glendale, Wisconsin 53217, United States; Active, not recruiting

Local Institution, Merida, Yucatan 97000, Mexico; Recruiting
Site 052

Local Institution, Merida, Yucatan 97000, Mexico; Recruiting
Site 051

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2010
Last updated: October 24, 2012