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
- Conditions
- -M05M05
- Registration Number
- PER-041-15
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 43
a) Subjects have early RA, defined as diagnosis made by the ACR/EULAR 2010 criteria for the classification
of RA within the past 6 months
b) Subjects must meet at least one of the following criteria:
i) CRP > 0.3mg/dL (ULN)
ii) ESR > 28mm/hr
c) Subjects have at least 3 tender joints and at least 3 swollen joints using the 28 Joint Count Assessment at
both screening and Day 1
d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
a) Subjects at risk for tuberculosis
b) Subjects with recent acute infection
c) Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections.
d) Subjects who have present or previous malignancies, except documented history of cured non-metastatic
squamous or basal skin cell carcinoma, or cervical carcinoma in situ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method