DISCO-RA:DIScontinuation of COncomitant disease modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors - a randomized long-term non-inferiority strategy trial

Rheumatoid arthritis

The primary endpoint is the between-group difference in mean time-weighted DAS28-CRP during 24 months of follow-up. A mean time-weighted DAS28-CRP is chosen to balance the limitations of assessing disease activity at a single timepoint with solely considering the occurrence of flare. The time-weighted DAS28-CRP consists of a weighted average of a patient’s DAS28-CRP scores, calculated using the trapezoid method and weighed by the time interval between measurements.

Disease activity measured by DAS28-CRP at 3, 6, 12, 18 and 24 months, Proportion of patients in remission (DAS28-CRP ≤ 2.4) or LDA (DAS28-CRP ≤ 2.9) at 3, 6, 12, 18, and 24 months, Fatigue and pain, measured by the Numeric Pain Rating Scale 0-10 (NRS 0–10), at baseline, 3, 6, 12, 18 and 24 months and at flare visits, Disease impact, measured by Rheumatoid Arthritis Impact of Disease (RAID) questionnaire, at baseline, 3, 6, 12, 18 and 24 months and at flare visits, Disease impact, measured by Patient Acceptable Symptom State (PASS) at baseline, 3, 6, 12, 18 and 24 months and at flare visits, Disease impact, measured by Transition scale at baseline, 3, 6, 12, 18 and 24 months and at flare visits, Medication adherence, measured by Medical Adherence Rating Scale (MARS), at baseline, 3, 6, 12, 18 and 24 months and at flare visits, Change between baseline and 24 months in Simple Erosion Narrowing Score (SENS) for radiographic joint damage, Health Assessment Questionnaire-Disability Index (HAQ-DI) at baseline, 3, 6, 12, 18 and 24 months and at flare visits, Euro Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire at baseline, 3, 6, 12, 18 and 24 months and at flare visits, TNFi and ADA serum levels at baseline, 3 (csDMARD discontinuation group only), and 24 months, Proportion of patients relapsing/restarting combination therapy over 24 months, Flare (DAS28-CRP increase from baseline of >1.2, or >0.6 if current DAS28-CRP >2.9) incidence calculated by cumulative incidence and incidence density (events per person-years) over 24 months, Time-to-event analysis of first flare over 24 months, Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) over 24 months, Proportion of patients in the csDMARD discontinuation group using a csDMARD and/or TNFi at 24 months, Proportion of patients who have discontinued the baseline TNFi at month 24, including those who discontinue or switch to another b/tsDMARD at the 24-month visit, Dosing and route of administration of csDMARD and/or TNFi at 24 months, MTX and LEF usage characteristics, including route of administration, use and dosage of folic acid, and other RA-related comedication over 24 months, Medical costs measured using the institute for Medical Technology Assessment Medical Consumption Questionnaire (iMTA MCQ) at baseline, 3, 6, 12, 18 and 24 months, Productivity losses and participation measured using the institute for Medical Technology Assessment Productivity Cost Questionnaire (iMTA PCQ) and Work Productivity and Activity Impairment questionnaire (WPAI) at baseline, 3, 6, 12, 18 and 24 months, Prediction modelling using baseline pharmacological factors (TNFi levels and ADA levels) and drug and ADA levels after discontinuation of csDMARDs (3 months)

No related papers found yet.