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

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

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-19

Primary Completion

2024-10-19

Completion

2025-10-19

Countries

• Germany

Study Locations