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

Sponsor
Dr. Frank Behrens
Study ID
NCT04485325
Phase
PHASE4
Status
Completed

Conditions

  • Rheumatic Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    5 mg twice daily, p.o.
  • Etanercept — BIOLOGICAL
    50 mg once per week, s.c.

Study Details

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.

Key Dates

Start date
Nov 4, 2019
Status verified
Aug 2024
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tofacitinib
    Tofacitinib (Xeljanz®; 5 mg twice daily, p.o.)
  • Active Comparator: Etanercept
    Etanercept (Enbrel®; 50 mg once per week, s.c.)

Primary Outcome Measure

Discontinuation of Celecoxib treatment and clinically relevant improvement in pain [ Time Frame: Baseline to week 12 ]

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