Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA).

Phase 1

• Conditions: Psoriatic Arthritis; MedDRA version: 21.0Level: LLTClassification code: 10037160Term: Psoriatic arthritis Class: 10028395; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2024-511401-40-00
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age = 18 years, - Clinical diagnosis of PsA made by rheumatologist and fulfilling criteria defined by the classification Criteria for PsA (CASPAR), - Onset of PsA symptoms = 24 weeks prior to screening visit, - Active disease per rheumatologist’ss opinion, - At least 1 swollen joint which is suitable for ultrasound guided synovial biopsy at BL, - Women of childbearing age and men capable of fathering children have to use adequate birth control measures during the study and for 6 months after the last administration of the study medication, - Able and willing to give written informed consent and participate in the study

Exclusion Criteria

-Previous treatment with: DMARDs; Oral, IA, IV or IM GC’s within 4 weeks before BL; IA steroids in the target joint = 6 weeks before synovial biopsy; An investigational drug for the treatment/prevention of PsA, - Alcohol or drug abuse, - History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex, - History of malignancies within the last 5 years, - History of any inflammatory rheumatic disease other than PsA, - Use of anticoagulation or anti-aggregation therapy (other than low-dose aspirin and NSAIDs), - Intolerance/allergy to lidocaine, - Underlying hematological, thromboembolic, cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study, - Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice), - Active hepatitis B and C infection, - Active tuberculosis (TB), - Latent TB unless adequate prophylactic treatment is given according to local guidelines

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): -The proportion of patients achieving a status of clinical remission at week 24.;Main Objective: To evaluate the effect of tofacitinib in remission induction and to document extended drug-free follow-up status after treatment with tofacitinib in early DMARD naïve PsA patients.;Secondary Objective: To explore the underlying molecular mechanisms in affected synovium with the aim of treatment response prediction.