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Abatacept Post-marketing Clinical Study in Japan

This study is not yet open for participant recruitment.
Verified April 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01758198
First received: December 19, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • Non-progressors rate for the structural damage [ Time Frame: Baseline (Day 1), 6 months (Week 24) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • ACR 70 response rates [ Time Frame: 4 months (Week16) ] [ Designated as safety issue: No ]
  • Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities [ Time Frame: 12 months (Week52) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758198

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01758198     History of Changes
Other Study ID Numbers: IM101-338
Study First Received: December 19, 2012
Last Updated: April 30, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abatacept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 23, 2013