Reducing Immunosuppressants in Stable Psoriatic Arthritis Patients
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
This study tests if people with stable psoriatic arthritis can safely lower or stop their immunosuppressive medications without having their symptoms come back.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | Adalimumab, Infliximab, Golimumab, Certolizumab, Ustekinumab, Secukinumab, Ixekizumab, Tofacitinib, Methotrexate |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT04610476 on ClinicalTrials.gov |
What this trial studies
This study investigates whether patients with psoriatic arthritis (PsA) who are in stable remission can safely taper or discontinue their immunosuppressive medications while maintaining their remission status. It employs a pragmatic treatment algorithm that allows for gradual medication reduction and includes escape strategies to manage any potential flare-ups. The goal is to provide reliable data on how to effectively reduce medication in these patients, which can be applied in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of psoriatic arthritis who have maintained minimal disease activity for at least six months.
Not a fit: Patients who have not achieved stable remission or have not been on a consistent treatment regimen for at least six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow patients to maintain remission from psoriatic arthritis while reducing their reliance on immunosuppressive drugs.
How similar studies have performed: While tapering immunosuppressants in stable patients is a common clinical consideration, this specific approach and algorithm have not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erlangen, Bavaria
- Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: David Simon, MD
- Email: david.simon@uk-erlangen.de
- Phone: +4991318532093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.