Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT04610476
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisolone — DRUG
    Prednisolone oral 1-5 mg/day
  • Sulfasalazine — DRUG
    Sulfasalazine oral 2 x 1000 mg/day
  • Leflunomide — DRUG
    Leflunomide oral 20 mg/day
  • Methotrexate — DRUG
    Methotrexate oral \> 10 - 30 mg/ week/ 10 mg/week/ 7.5 mg/week; s.c. 15 (7.5 -25) mg/week
  • Tofacitinib — DRUG
    Tofacitinib oral 2 x 5 mg/day/ 1 x 5 mg/day/11 mg/day
  • Apremilast — DRUG
    Apremilast oral 2 x 30 mg/day/1 x 30 mg/day
  • Etanercept — DRUG
    Etanercept s.c. 2 x 25 mg /week OR 1 x 50 mg/week
  • Adalimumab — DRUG
    Adalimumab s.c. 40 mg every 2 weeks
  • Infliximab — DRUG
    Infliximab i.v. 5 mg/kg BW every 8 weeks
  • Certolizumab pegol — DRUG
    Certolizumab pegol s.c. 1x 200 mg every 2 weeks/1x400 mg every 4 weeks
  • Golimumab — DRUG
    Golimumab s.c. 1x 50 mg every 4 weeks
  • Abatacept — DRUG
    Abatacept s.c. 1x125 mg/week OR Abatacept i.v. 500-1000mg (adapted to BW) every 4 weeks
  • Secukinumab — DRUG
    Secukinumab s.c.1x 150 mg OR 1x 300 mg every 4 weeks
  • Ixekizumab — DRUG
    Ixekizumab s.c. 1x 80 mg every 4 weeks
  • Ustekinumab — DRUG
    Ustekinumab s.c. Maintenance dose 1x45 mg every 12 weeks

Study Details

The rationale for this study is to investigate whether in psoriatic arthritis (PsA) patients in stable remission a reduction or complete discontinuation of immunosuppressive therapy can be achieved in a treat-to-target approach while maintaining in remission. Due to the lack of reliable data that answers the question of how to safely reduce medication in which patients, this study will test a pragmatic treatment algorithm that can be applied in clinical practice and that offers a gradual reduction with escape strategies in order to facilitate the maintenance of remission.

Key Dates

Start date
Oct 19, 2020
Status verified
Nov 2022
Primary completion
Oct 19, 2024
Completion
Oct 19, 2025

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control group
    Individual previous stable glucocorticoid/DMARD therapy is continued
  • Experimental: Reduction group
    Individual previous stable dosage of glucocorticoids/DMARDs will be stepwise reduced according to a predefined algorithm

Primary Outcome Measure

Presence of MDA (minimal disease activity) 12 months after baseline. [ Time Frame: 12 months ]

Central Contacts

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