Investigating the role of JAK inhibition in achieving and maintaining disease remission in early psoriatic arthritis (PsA).
- Conditions
- Psoriatic arthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2019-004177-35-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
- 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
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
-Previous treatment with:
o DMARDs
o Oral, IA, IV or IM GC’s within 4 weeks before BL
o IA steroids in the target joint = 6 weeks before synovial biopsy
o An investigational drug for the treatment/prevention of PsA
- 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
- Alcohol or drug abuse
- History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex
- History of malignancies within the last 5 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Primary end point(s): - The proportion of patients achieving a status of clinical remission at week 24.;Timepoint(s) of evaluation of this end point: week 24
- Secondary Outcome Measures
Name Time Method