E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic arthritis |
Psoriatische artritis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To explore the underlying molecular mechanisms in affected synovium with the aim of treatment response prediction. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
- The proportion of patients achieving a status of clinical remission at week 24. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
week12, week24, week 52 and week 104 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |