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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: JPRN
Last refreshed on: 16 July 2019
Main ID:  JPRN-JapicCTI-153081
Date of registration: 26/11/2015
Prospective Registration: No
Primary sponsor: Bristol-Myers Squibb K.K.
Public title: Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Scientific title: A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive
Date of first enrolment: 01/8/2015
Target sample size: 1000
Recruitment status: complete
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-153081
Study type:  INTERVENTIONAL
Study design:  Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment  
Phase:  3
Countries of recruitment
Contacts
Name:    
Address: 
Telephone:
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Affiliation: 
Name: Bristol-Myers Squibb K.K. Clinical Trials Contact Personnel   
Address:  mg-jp-clinical_trial@bms.com
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Rheumatoid arthritis (RA) diagnosis less than 6 months
CRP greater than 3 mg/L or Erythrocyte Sedimentation Rate (ESR) not less than 28 mm/h
At least 3 swollen and 3 tender joints
Anti-citrullinated protein antibodies (ACPA) positive

Exclusion criteria: At risk for tuberculosis
Have acute infection
Have chronic or recurrent bacterial or serious latent viral infection
History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)


Age minimum: 18
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Intervention name : Abatacept + Methotrexate
Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Control intervention name : Methotrexate
Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally
Control intervention name : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Control intervention name : Methotrexate Placebo
Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week
Primary Outcome(s)
Proportion of subjects in Simple Disease Activity Index (SDAI) remission [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome(s)
Proportion of subjects in Disease Activity Index (DAS)28 - c-reactive protein (CRP) remission [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Proportion of subjects in SDAI remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Mean change from baseline in radiographic progression of joint damage [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Proportion of subjects in Boolean remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Secondary ID(s)
Source(s) of Monetary Support
Refer to the information of contact(s)
Secondary Sponsor(s)
Ethics review
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Results
Results available:
Date Posted:
Date Completed:
URL:
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