Psoriatic arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Xeljanz
Pharmaceutical Form: Tablet
INN or Proposed INN: TOFACITINIB
CAS Number: 477600-75-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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. - 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 : o SJC66/TJC68 o Dactylitis severity score o Leeds enthesitis index o BSA - The evolution of patient-reported outcomes at week 4, week 12, week 24, week 28, week 52, week 76 and week 104: o PGA o Health Assessment Questionnaire – disability index (HAQ) o Short Form-36 physical functioning domain(SF-36) o EuroQol 5- dimension Health state Profile (EQ-5D) o 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 - Radiographic progression at week 52 and week 104 ;Timepoint(s) of evaluation of this end point: week12, week24, week 52 and week 104 | — |
Countries
Belgium
Contacts
Public ContactProf. Dr. Barbara Neerinckx
University Hospitals Leuven
Outcome results
None listed