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Abatacept Post-marketing Clinical Study in Japan

This study has been completed.
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: December 19, 2012
Last updated: May 12, 2017
Last verified: May 2017
The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.

Condition Intervention Phase
Rheumatoid Arthritis Biological: Abatacept Drug: Placebo matching with Abatacept Drug: Methotrexate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • American College of Rheumatology (ACR) 20% response rate [ Time Frame: 4 months (week 16) ]
  • Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24) [ Time Frame: Baseline (Day 1), 6 months (Week 24) ]

Secondary Outcome Measures:
  • Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16) [ Time Frame: Baseline (Day 1), 4 months (Week 16) ]
  • Non-progressors rate for the structural damage [ Time Frame: Baseline (Day 1), 6 months (Week 24) ]
    The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)

  • ACR 50 response rates [ Time Frame: 4 months (Week16) ]
  • ACR 70 response rates [ Time Frame: 4 months (Week16) ]
  • Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities [ Time Frame: 12 months (Week52) ]

Enrollment: 405
Actual Study Start Date: April 11, 2013
Study Completion Date: December 26, 2016
Primary Completion Date: December 26, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Abatacept + Methotrexate (MTX)

Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months

Methotrexate ≥6 mg/week for 12 months

Biological: Abatacept
Other Name: BMS-188667 (Orencia)
Drug: Methotrexate
Placebo Comparator: Group 2: Placebo matching with Abatacept + Methotrexate

Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months

Methotrexate ≥6 mg/week for 12 months

Drug: Placebo matching with Abatacept Drug: Methotrexate


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • MTX inadequate responder
  • Biologic Naïve
  • Functional class I, II or III
  • ≥6 swollen and ≥6 tender joints
  • C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
  • Anti-cyclic citrullinated peptide (CCP) antibody positive
  • Have erosion

Exclusion Criteria:

  • Any other rheumatic disease
  • Active angiitis on main organs excluding rheumatoid nodule
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01758198

  Show 74 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01758198     History of Changes
Other Study ID Numbers: IM101-338
Study First Received: December 19, 2012
Last Updated: May 12, 2017

Additional relevant MeSH terms:
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 processed this record on September 21, 2017