Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis
- Conditions
- Early Rheumatoid ArthritisMedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-001275-50-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- 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 an 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 Main Objective: The primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with MTX to MTX alone in achieving Remission, defined as SDAI = 3, at Week 24.;Secondary Objective: 1) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by DAS28-CRP Remission criteria at Week 24.<br>2) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by SDAI remission criteria at Week 52.<br>3) To compare the efficacy of weekly abatacept + MTX to MTX alone in reducing joint damage by X-ray at Week 52.<br>4) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by Boolean remission criteria at Week 52.;Primary end point(s): The primary efficacy endpoint is the proportion of subjects in SDAI Remission at Week 24.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints below will be assessed in the order below in a hierarchical fashion after the primary endpoint is met to preserve the type I error of the study at 5%<br>(1) Proportion of subjects in DA28-CRP Remission at Week 24<br>(2) Proportion of subjects in SDAI Remission at Week 52<br>(3) Mean change from baseline in TSS at Week 52<br>(4) Proportion of subjects in Boolean Remission at Week 52;Timepoint(s) of evaluation of this end point: (1) Week 24<br>(2) Week 52<br>(3) Week 52<br>(4) Week 52