An unblinded clinical Trial with random assignment to Treatment Groups in adult patients with psoriatic arthrits to evaluate how far immunosuppressive medication can be tapered without recurrence of symptoms

Phase 1

• Conditions: Psoriatic arthritis; MedDRA version: 21.1Level: PTClassification code 10037162Term: Psoriatic arthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-001899-14-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-28
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

- Diagnosis of PsA according to CASPAR criteria
- male or female adult subject; age >=18 years
- Disease status MDA” for at least 6 months; MDA is defined as the presence of 5 of the following 7 criteria:
a) tender joint count =1
b) swollen joint count =1
c) tender entheseal point count =1 (means: remission)
d) PASI =1 or body surface area =3
e) patient pain VAS =15
f) patient global activity VAS =20
g) HAQ-DI =0.5
- Disease Status MDA+; MDA+ is defined as the presence of 5 of the 7 criteria for MDA, whereby all musculoskeletal Domains a)-c) must fulfil the criteria
-suject 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),
Guselkumab (Tremfya),
Upadacitinib (Rinvoq),
Risankizumab (Skyrizi),
Tofacitinib (Xeljanz)

AND/OR
(c) glucocorticoids (=5mg prednisolone equivalent).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

- Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener
- Concomitant florid immune mediated disease such as autoimmune Hepatitis that is untreated and/or requires immunosuppressive treatment
- 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 or history of malignant disease within 5 years prior to screening, which could affect the reduction of immunosuppressive therapy
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified