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

NCT ID: NCT04610476

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2025-10-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Individual previous stable glucocorticoid/DMARD therapy is continued

Group Type: NO_INTERVENTION

No interventions assigned to this group

Reduction group

Individual previous stable dosage of glucocorticoids/DMARDs will be stepwise reduced according to a predefined algorithm

Group Type: EXPERIMENTAL

Prednisolone

Intervention Type: DRUG

Prednisolone oral 1-5 mg/day

Sulfasalazine

Intervention Type: DRUG

Sulfasalazine oral 2 x 1000 mg/day

Leflunomide

Intervention Type: DRUG

Leflunomide oral 20 mg/day

Methotrexate

Intervention Type: DRUG

Methotrexate oral \> 10 - 30 mg/ week/ 10 mg/week/ 7.5 mg/week; s.c. 15 (7.5 -25) mg/week

Tofacitinib

Intervention Type: DRUG

Tofacitinib oral 2 x 5 mg/day/ 1 x 5 mg/day/11 mg/day

Apremilast

Intervention Type: DRUG

Apremilast oral 2 x 30 mg/day/1 x 30 mg/day

Etanercept

Intervention Type: DRUG

Etanercept s.c. 2 x 25 mg /week OR 1 x 50 mg/week

Adalimumab

Intervention Type: DRUG

Adalimumab s.c. 40 mg every 2 weeks

Infliximab

Intervention Type: DRUG

Infliximab i.v. 5 mg/kg BW every 8 weeks

Certolizumab pegol

Intervention Type: DRUG

Certolizumab pegol s.c. 1x 200 mg every 2 weeks/1x400 mg every 4 weeks

Golimumab

Intervention Type: DRUG

Golimumab s.c. 1x 50 mg every 4 weeks

Abatacept

Intervention Type: DRUG

Abatacept s.c. 1x125 mg/week OR Abatacept i.v. 500-1000mg (adapted to BW) every 4 weeks

Secukinumab

Intervention Type: DRUG

Secukinumab s.c.1x 150 mg OR 1x 300 mg every 4 weeks

Ixekizumab

Intervention Type: DRUG

Ixekizumab s.c. 1x 80 mg every 4 weeks

Ustekinumab

Intervention Type: DRUG

Ustekinumab s.c. Maintenance dose 1x45 mg every 12 weeks

Interventions

Prednisolone

Prednisolone oral 1-5 mg/day

Intervention Type: DRUG

Sulfasalazine

Sulfasalazine oral 2 x 1000 mg/day

Intervention Type: DRUG

Leflunomide

Leflunomide oral 20 mg/day

Intervention Type: DRUG

Methotrexate

Methotrexate oral \> 10 - 30 mg/ week/ 10 mg/week/ 7.5 mg/week; s.c. 15 (7.5 -25) mg/week

Intervention Type: DRUG

Tofacitinib

Tofacitinib oral 2 x 5 mg/day/ 1 x 5 mg/day/11 mg/day

Intervention Type: DRUG

Apremilast

Apremilast oral 2 x 30 mg/day/1 x 30 mg/day

Intervention Type: DRUG

Etanercept

Etanercept s.c. 2 x 25 mg /week OR 1 x 50 mg/week

Intervention Type: DRUG

Adalimumab

Adalimumab s.c. 40 mg every 2 weeks

Intervention Type: DRUG

Infliximab

Infliximab i.v. 5 mg/kg BW every 8 weeks

Intervention Type: DRUG

Certolizumab pegol

Certolizumab pegol s.c. 1x 200 mg every 2 weeks/1x400 mg every 4 weeks

Intervention Type: DRUG

Golimumab

Golimumab s.c. 1x 50 mg every 4 weeks

Intervention Type: DRUG

Abatacept

Abatacept s.c. 1x125 mg/week OR Abatacept i.v. 500-1000mg (adapted to BW) every 4 weeks

Intervention Type: DRUG

Secukinumab

Secukinumab s.c.1x 150 mg OR 1x 300 mg every 4 weeks

Intervention Type: DRUG

Ixekizumab

Ixekizumab s.c. 1x 80 mg every 4 weeks

Intervention Type: DRUG

Ustekinumab

Ustekinumab s.c. Maintenance dose 1x45 mg every 12 weeks

Intervention Type: DRUG

Other Intervention Names

Prednisolone generic drugs; Azulfidine; Arava; Lantarel, Metex; Xeljanz; Otezla; Enbrel, Erelzi, Benepali; Humira, Amgevita, Imraldi, Hyrimoz; Remicade, Zessly, Inflectra; Cimzia; Simponi; Orencia; Cosentyx; Taltz; Stelara

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained from the subject
• Understanding of study procedures and willingness to abide by all procedures during the course of the study.
• Adult subject; age range 18-≤75 years
• Male or female subject
• Diagnosis of PsA according to CASPAR criteria
• Disease status "MDA" for at least 6 months
• Subject should have been treated without alterations of therapy (fixed dose and drug) for at least 6 months with one or more of the following drugs:

i. csDMARD Leflunomid (e.g. Arava), Sulfasalazin (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) AND/OR ii. bDMARD/tsDMARD: Etanercept (e.g. Enbrel, Erelzi, Benepali), Adalimumab (e.g. Humira, Amgevita, Imraldi, Hyrimoz), Infliximab (e.g. Remicade, Zessly, Inflectra), Golimumab (Simponi), Certolizumab (Cimzia), Abatacept (Orencia), Apremilast (Otezla), Ustekinumab (Stelara), Secukinumab (Cosentyx), Ixekizumab (Taltz), Tofacitinib (Xeljanz) AND/OR (c) glucocorticoids (≤5mg prednisolone equivalent).

• Women of childbearing potential must be using a highly effective method of birth control.
• Male subjects using an adequate contraceptive method at the investigator's discretion.

Exclusion Criteria

• Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener
• Concomitant florid (not sufficiently adjusted under treatment) autoimmune disease such as autoimmune hepatitis or Hashimoto's disease
• Use of any inadmissible medication (e.g. current treatment with DMARDs other than mentioned above or drugs under development)
• Treatment with systemic glucocorticoids (daily dose >5mg prednisolone equivalent) during the last 6 months before randomization. Intra-articular or entheseal injections of glucocorticoids do not constitute an exclusion criterion
• Malignant disease currently under oncological treatment or history of a recent malignancy with moderate or high risk of relapse within 5 years prior to Screening
• Existence of another disease including the presence of laboratory abnormalities which, at the discretion of the investigator, would result in a disproportionate risk to the patient concerned or confounds the ability to interpret data from the study
• Any anti-inflammatory (excluding NSAIDs) or immunosuppressive therapy for other reasons than PsA or psoriasis during the last 3 months before Screening
• Nursing mother or pregnant woman as verified by a positive pregnancy test
• Known hypersensitivity to the IMPs or any of their formulation ingredients
• Subject who is imprisoned or is lawfully kept in an Institution
• Employee or direct relative of an employee of the study site or the Sponsor
• Participation in an interventional clinical study with an IMP within the last 4 weeks before Screening
• Previous participation in this clinical study
• Planned extended stay outside the region which prevents compliance with the visit schedule

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

David Simon, MD

Role: CONTACT

david.simon@uk-erlangen.de

+4991318532093

Arnd Kleyer, MD

Role: CONTACT

arnd.kleyer@uk-erlangen.de

+4991318532093

Facility Contacts

David Simon, MD

Role: primary

david.simon@uk-erlangen.de

+4991318532093

Arnd Kleyer, MD

Role: backup

arnd.kleyer@uk-erlangen.de

+4991318532093

Other Identifiers

UKER-ATTRACTOR -01

Identifier Type: -

Identifier Source: org_study_id