drugset / Trial / NCT04485325

Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients

NCT04485325

Phase 4 Completed 92 enrolled Dr. Frank Behrens Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients with active rheumatic arthritis (RA) and lack of efficacy of at least one csDMARD (Disease-modifying anti-rheumatic drug) treatment will be randomized to receive either Tofacitinib (TOFA) or etanercept (ETA). The study will be separated into two parts: The capability to decrease and discontinue pain-reducing treatment with a NSAID (non-steroidal anti-inflammatory drug) over the first 12 weeks of treatment will be measured for primary outcome measured using a visual analogue scale (VAS) at week 12 compared to baseline between the two treatment groups. Starting at week 12, the capability to taper corticosteroid (CS) treatment using a treat-to-target strategy, i.e. when at least low disease activity (LDA-DAS28) is achieved, will be measured in both groups.

Timeline

Start
2019-11-04
Primary completion
2024-03-31
Completion
2024-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etanercept Protein / enzyme biologic 50 mg Subcutaneous
Comparator Tofacitinib Small molecule 5 mg Oral

Indications