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

University of Erlangen-Nürnberg Medical School

Status and phase: Enrolling; Phase 3

Conditions: Withdrawal; Reduction; Psoriatic Arthritis

Treatments: Drug: Adalimumab; Drug: Prednisolone; Drug: Ustekinumab; Drug: Certolizumab pegol; Drug: Methotrexate; Drug: Abatacept; Drug: Secukinumab; Drug: Golimumab; Drug: Apremilast; Drug: Sulfasalazine; Drug: Etanercept; Drug: Infliximab; Drug: Tofacitinib; Drug: Ixekizumab; Drug: Leflunomide

Study type: Interventional

Funder types: Other

Identifiers

NCT04610476

UKER-ATTRACTOR -01

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Control group

No Intervention group

Description:

Individual previous stable glucocorticoid/DMARD therapy is continued

Reduction group

Experimental group

Description:

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

Treatment:

Drug: Methotrexate

Drug: Leflunomide

Drug: Ixekizumab

Drug: Tofacitinib

Drug: Infliximab

Drug: Etanercept

Drug: Sulfasalazine

Drug: Apremilast

Drug: Golimumab

Drug: Secukinumab

Drug: Abatacept

Drug: Ustekinumab

Drug: Certolizumab pegol

Drug: Prednisolone

Drug: Adalimumab