drugset
drugset / Trial / NCT04610476

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

NCT04610476 ↗

Phase 3 Unknown 270 enrolled University of Erlangen-Nürnberg Medical School
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-10-19
Primary completion
2024-10-19
Completion
2025-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 125 mg Subcutaneous
Subject Abatacept Other / unclassified 500 mg Subcutaneous
Subject Abatacept Other / unclassified 1000 mg Subcutaneous
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Apremilast Small molecule 30 mg Oral
Subject Certolizumab Pegol Protein / enzyme biologic 200 mg Subcutaneous
Subject Certolizumab Pegol Protein / enzyme biologic 400 mg Subcutaneous
Subject Etanercept Protein / enzyme biologic 25 mg Subcutaneous
Subject Etanercept Protein / enzyme biologic 50 mg Subcutaneous
Subject Golimumab Monoclonal antibody 50 mg Subcutaneous
Subject Infliximab Monoclonal antibody 5 mg/kg Intravenous
Subject Ixekizumab Monoclonal antibody 80 mg Subcutaneous
Subject Leflunomide Small molecule 20 mg Oral
Subject Methotrexate Small molecule 7.5 mg Oral
Subject Methotrexate Small molecule 10 mg Oral
Subject Methotrexate Small molecule 15 mg Oral
Subject Methotrexate Small molecule 25 mg Oral
Subject Methotrexate Small molecule 30 mg Oral
Subject Prednisolone Other / unclassified 1 mg Oral
Subject Prednisolone Other / unclassified 5 mg Oral
Subject Secukinumab Monoclonal antibody 150 mg Subcutaneous
Subject Secukinumab Monoclonal antibody 300 mg Subcutaneous
Subject Sulfasalazine Small molecule 1000 mg Oral
Subject Tofacitinib Small molecule 5 mg Oral
Subject Tofacitinib Small molecule 11 mg Oral
Subject Ustekinumab Monoclonal antibody 45 mg Subcutaneous

Indications

psoriatic arthritis substance withdrawal syndrome