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

Phase 4

Active, not recruiting

• Conditions: Psoriatic Arthritis

• Registration Number: 2024-511401-40-00
• Lead Sponsor: UZ Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• 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
- The proportion of patients achieving a status of clinical remission at week 24.		- The proportion of patients achieving a status of clinical remission at week 24.

Secondary Outcome Measures

Name	Time	Method
- The proportion of patients in drug-free remission at week 52 and week 104.		- The proportion of patients in drug-free remission at week 52 and week 104.
- Time to relapse in patients experiencing a flare after treatment cessation.		- Time to relapse in patients experiencing a flare after treatment cessation.
- The evolution of arthritis, dactylitis, enthesitis and skin involvement at week 4, week 12, week 24, week 28, week 52, week 76 and week 104, measured by : SJC66/TJC68; Dactylitis severity score; Leeds enthesitis index; BSA		- The evolution of arthritis, dactylitis, enthesitis and skin involvement at week 4, week 12, week 24, week 28, week 52, week 76 and week 104, measured by : SJC66/TJC68; Dactylitis severity score; Leeds enthesitis index; BSA
- The evolution of patient-reported outcomes at week 4, week 12, week 24, week 28, week 52, week 76 and week 104: PGA; Health Assessment Questionnaire – disability index (HAQ); Short Form-36 physical functioning domain(SF-36); EuroQol 5- dimension Health state Profile (EQ-5D); PsA Impact of Disease (PsAID)		- The evolution of patient-reported outcomes at week 4, week 12, week 24, week 28, week 52, week 76 and week 104: PGA; Health Assessment Questionnaire – disability index (HAQ); Short Form-36 physical functioning domain(SF-36); EuroQol 5- dimension Health state Profile (EQ-5D); PsA Impact of Disease (PsAID)
- Percentage of patients achieving the PsA response criteria (PsARC), minimal disease activity (MDA) and 85% change in Disease activity (DAPSA) at week 12, week 24, week 52, week 76 and week 104		- Percentage of patients achieving the PsA response criteria (PsARC), minimal disease activity (MDA) and 85% change in Disease activity (DAPSA) at week 12, week 24, week 52, week 76 and week 104
- Radiographic progression at week 52 and week 104		- Radiographic progression at week 52 and week 104

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium

UZ Leuven

🇧🇪Leuven, Belgium

Barbara Neerinckx

Site contact

+3216342541

barbara.neerinckx@uzleuven.be