Abatacept Post-marketing Clinical Study in Japan

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 19, 2014
Last verified: August 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 #.

Locations
Japan
Local Institution Recruiting
Asahi, Japan, 289-2511
Contact: Site 0028         
Local Institution Recruiting
Fuchu, Japan, 183-8524
Contact: Site 0050         
Local Institution Recruiting
Fukuoka, Japan, 813-0017
Contact: Site 0019         
Local Institution Recruiting
Hakodate, Japan, 040-8611
Contact: Site 0040         
Local Institution Recruiting
Hitachi, Japan, 316-0015
Contact: Site 0004         
Local Institution Recruiting
Iizuka, Japan, 820-8505
Contact: Site 0020         
Local Institution Recruiting
Kagoshima, Japan, 891-0133
Contact: Site 0051         
Local Institution Recruiting
Kagoshima, Japan, 890-0067
Contact: Site 0023         
Local Institution Recruiting
Kanazawa, Japan, 920-8616
Contact: Site 0011         
Local Institution Recruiting
Kasama, Japan, 309-1793
Contact: Site 0005         
Local Institution Recruiting
Kato, Japan, 673-1462
Contact: Site 0015         
Local Institution Recruiting
Kitakyushu, Japan, 807-8556
Contact: Site 0043         
Local Institution Recruiting
Kitakyushu, Japan, 800-0031
Contact: Site 0018         
Local Institution Recruiting
Kitakyushu, Japan, 800-0296
Contact: Site 0031         
Local Institution Recruiting
Kitamoto, Japan, 364-8501
Contact: Site 0033         
Local Institution Recruiting
Kochi, Japan, 781-0112
Contact: Site 0048         
Local Institution Recruiting
Koshi, Japan, 861-1196
Contact: Site 0022         
Local Institution Recruiting
Matsumoto, Japan, 390-8601
Contact: Site 0013         
Local Institution Recruiting
Nagano, Japan, 380-8582
Contact: Site 0012         
Local Institution Recruiting
Nagaoka, Japan, 940-2085
Contact: Site 0010         
Local Institution Recruiting
Nagasaki, Japan, 850-0832
Contact: Site 0032         
Local Institution Recruiting
Nagoya, Japan, 466-8560
Contact: Site 0042         
Local Institution Recruiting
Nagoya, Japan, 460-0001
Contact: Site 0014         
Local Institution Recruiting
Narashino, Japan, 275-0006
Contact: Site 0049         
Local Institution Recruiting
Narita, Japan, 286-0041
Contact: Site 0027         
Local Institution Recruiting
Okayama, Japan, 700-8607
Contact: Site 0016         
Local Institution Recruiting
Osaki, Japan, 989-6183
Contact: Site 0025         
Local Institution Recruiting
Sapporo, Japan, 060-0001
Contact: Site 0024         
Local Institution Recruiting
Sapporo, Japan, 063-0811
Contact: Site 0001         
Local Institution Recruiting
Sapporo, Japan, 060-8648
Contact: Site 0039         
Local Institution Recruiting
Sasebo, Japan, 857-1195
Contact: Site 0021         
Local Institution Recruiting
Sayama, Japan, 350-1305
Contact: Site 0007         
Local Institution Recruiting
Sendai, Japan, 982-0032
Contact: Site 0003         
Local Institution Recruiting
Sendai, Japan, 983-8512
Contact: Site 0026         
Local Institution Recruiting
Sendai, Japan, 980-6116
Contact: Site 0037         
Local Institution Recruiting
Shizuoka, Japan, 420-0821
Contact: Site 0046         
Local Institution Recruiting
Takaoka, Japan, 933-0874
Contact: Site 0029         
Local Institution Recruiting
Takasaki, Japan, 370-0053
Contact: Site 0044         
Local Institution Recruiting
Tokyo, Japan, 173-8610
Contact: Site 0034         
Local Institution Recruiting
Tokyo, Japan, 174-0071
Contact: Site 0009         
Local Institution Recruiting
Tokyo, Japan, 104-8560
Contact: Site 0045         
Local Institution Recruiting
Tokyo, Japan, 160-8582
Contact: Site 0035         
Local Institution Recruiting
Tokyo, Japan, 162-8655
Contact: Site 0047         
Local Institution Recruiting
Tomakomai, Japan, 053-0018
Contact: Site 0002         
Local Institution Recruiting
Toyama, Japan, 930-0194
Contact: Site 0038         
Local Institution Recruiting
Toyama, Japan, 930-0138
Contact: Site 0030         
Local Institution Recruiting
Utsunomiya, Japan, 321-0964
Contact: Site 0006         
Local Institution Recruiting
Yotsukaido, Japan, 284-0003
Contact: Site 0008         
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: August 19, 2014
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 August 28, 2014