Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis
- Conditions
- Early Rheumatoid ArthritisMedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-001275-50-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1500
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 (Appendix 11)
d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
e) Subjects have SDAI > 11
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
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
e) Creatinine clearance < 40 mL/min (Cockroft-Gault formula)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method