NCT02778906

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthralgia
• Arthritis

Interventions

Type	Name	Description
DRUG	Abatacept	Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis
DRUG	Placebo	Administration of the comparator s.c. weekly in comparable to verum

Timeline

• Start date: 2014-11-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-05-20
• Last updated: 2020-03-10

Locations

9 sites across 1 country: Germany