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Abatacept Post-marketing Clinical Study in Japan

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. Identifier: NCT01758198
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : May 15, 2017
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Abatacept Drug: Placebo matching with Abatacept Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
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
Actual Study Start Date : April 11, 2013
Actual Primary Completion Date : December 26, 2016
Actual Study Completion Date : December 26, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. American College of Rheumatology (ACR) 20% response rate [ Time Frame: 4 months (week 16) ]
  2. 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 :
  1. Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16) [ Time Frame: Baseline (Day 1), 4 months (Week 16) ]
  2. 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)

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

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01758198

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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT01758198     History of Changes
Other Study ID Numbers: IM101-338
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Connective Tissue Diseases
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic 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