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

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.

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