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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01758198
Date of registration: 19/12/2012
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Abatacept Post-marketing Clinical Study in Japan
Scientific 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
Date of first enrolment: April 11, 2013
Target sample size: 405
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01758198
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Japan
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: Abatacept
Drug: Methotrexate
Drug: Placebo matching with Abatacept
Primary Outcome(s)
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(s)
ACR 50 response rates [Time Frame: 4 months (Week16)]
ACR 70 response rates [Time Frame: 4 months (Week16)]
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)]
Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities [Time Frame: 12 months (Week52)]
Secondary ID(s)
IM101-338
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ono Pharmaceutical Co. Ltd
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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