2024-511401-40-00CompletedPhase 4
Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA).
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 19 Feb 2024
- Start date
- 3 Mar 2020
- Lead sponsor
- UZ Leuven
- Diseases
- Psoriatic arthritis
- EU CT number
- 2024-511401-40-00
- EudraCT number
- 2019-004177-35
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- -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)
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.