Abatacept Post-marketing Clinical Study in Japan
NCT01758198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 405
Last updated 2017-05-15
Summary
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.
Conditions
Interventions
- BIOLOGICAL
- DRUG
-
Placebo matching with Abatacept
- DRUG
-
Methotrexate
Sponsors & Collaborators
-
Ono Pharmaceutical Co. Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-11
- Primary Completion
- 2016-12-26
- Completion
- 2016-12-26
Countries
- Japan
Study Locations
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