Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA).
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- 4. fázis
Where in Belgium
- UZ LeuvenLeuven, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2024-511401-40-00
- Record updated
- 2024. április 3.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: -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; Use of anticoagulation or anti-aggregation therapy (other than low-dose aspirin and NSAIDs); 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; 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; Active hepatitis B and C infection; Active tuberculosis (TB); Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice); Latent TB unless adequate prophylactic treatment is given according to local guidelines.