drugset / Trial / NCT02778906

Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia

NCT02778906

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

EvaluationDrugModalityDoseRoute
Comparator Abatacept Other / unclassified 125 mg Subcutaneous