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Abatacept Post-marketing Clinical Study in Japan

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01758198
First received: December 19, 2012
Last updated: October 9, 2014
Last verified: October 2014
  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:


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: May 2016
Estimated Primary Completion Date: May 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

  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
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 ClinicalTrials.gov identifier: NCT01758198

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 50 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional 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: October 9, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abatacept
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014