NCT04610476

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

A Prospective, Randomized, Controlled, Open Label, Assessor-blinded, Parallel-group Phase III Clinical Trial to Evaluate the Impact of Tapering Systemic Immunosuppressive Therapy in a Treat-to-target Approach on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Psoriatic Arthritis
• Withdrawal
• Reduction

Interventions

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

Timeline

• Start date: 2020-10-19
• Primary completion: 2024-10-19
• Completion: 2025-10-19
• First posted: 2020-10-30
• Last updated: 2022-11-14

Locations

1 site across 1 country: Germany