drugset / Trial / NCT02778906
Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia
Phase 3
Completed
98 enrolled
University of Erlangen-Nürnberg Medical School
Bristol-Myers Squibb · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomised double-blinded placebo-controlled multi centre study in 98 patients with ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6 months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the follow up period for another 12 months up to month 18. Patients developing arthritis will be treated according to local guidelines.
Timeline
- Start
- 2014-11
- Primary completion
- 2019-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abatacept | Other / unclassified | 125 mg | Subcutaneous |