Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM study

• Conditions: rheumatoid arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-002156-27-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-30
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of RA according to the 2010 ACR/EULAR classification criteria
• Current treatment with RTX (at time of inclusion have already received at least 2 cycles of 1000mg RTX) at the Day-Clinic of the Division of Rheumatology of the Medical University of Vienna
• Persistent low disease activity or clinical remission. Persistent clinical remission (pREM) will be defined as a simplified disease activity index (CDAI) =2.8 measured at two time-points 6 months apart. The CDAI is calculated as follows: TJC + SJC + GH + EGH (EGH=evaluator's
assessment of general health on a 100 mm VAS, GH=patient's assessment of general health on a 100 mm VAS, SJC=28 swollen joint count, TJC=28 tender joint count).
• Persistent low disease activity (pLDA) will be defined as a CDAI =10 measured at two timepoints 6 months apart
• Patients who achieve REM at only either one of the two successive time-points will be considered as having pLDA with regard to the current trial
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Patients = 18 yrs
• Patients receiving RTX for a disease other than RA
• Patients who fail to meet criteria for REM or LDA at either one of the two successive timepoints (i.e. having a disease activity >10 as measured by the CDAI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified