Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis

• Status: Terminated
• Trial end date: 2020-11-19
• Target enrollment: 0
• Participant gender: All

Summary

biological DMARDs may be stopped in Rheumatoid Arthritis (RA) patients treated with a combination of synthetic DMARD plus bDMARDs which are in persistent clinical remission. The research question of this study is, whether musculoskeletal sonography is a useful biomarker predicting a disease flare after cessation of bDMARD therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Abatacept; Adalimumab; Certolizumab Pegol; Etanercept; Golimumab; Infliximab

Criteria

Inclusion Criteria:

• Male or female patient ≥18 years and <90 years of age

• Classification of RA according to the ACR/EULAR 2010 criteria

• Persistent clinical remission as defined by the ACR/EULAR remission criteria for at least 6 months (documented at ≥2 visits)

• Written informed consent

• Current treatment with a single csDMARD or a combination of csDMARDs plus a stable dose and administration interval (for the last 6 months) of a TNF-alpha inhibitor

• No current systemic corticosteroid treatment (stopped for at least 4 weeks), no corticosteroid injection within 4 weeks

• Stable dose of NSAIDs for at least 1 week

Exclusion Criteria:

• • Current treatment with any investigational drug

• Current administration interval of the anti-TNF-alpha agent of >11 weeks

• Complete destruction of any joint to be investigated by sonography

• Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA- manifestation with the exception of rheumatoid nodules

• Initial arthritis manifestations before the age of 17 years

• Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography

• Current severe medical illness requiring hospitalization

• Active infection or active malignancy at screening or infection during the past 4 weeks requiring (even temporary) discontinuation of the anti-TNF-alpha agent

• Pregnancy or lactation

• Inability of the patient to follow the protocol

• Current treatment with Rituximab (MabThera®)