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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04610476
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Erlangen-Nürnberg Medical School
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis, Withdrawal, Reduction
Arms & Interventions

Arms

No Intervention: Control group

Individual previous stable glucocorticoid/DMARD therapy is continued

Experimental: Reduction group

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

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

Contact a Trial Team

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International Sites

Universitätsklinikum Erlangen, Erlangen, Bavaria, Germany

Status

Recruiting

Address

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054

Site Contact

David Simon, MD

david.simon@uk-erlangen.de

+4991318532093

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