TOFA-PREDICT
Key facts
- Where
- Amsterdam, Enschede, Maastricht, Tilburg, Utrecht és Venlo, HollandiaSee the 6 sites
- Phase
- 4. fázis
Where in Hollandia
- Stichting ReadeAmsterdam, HollandiaNo longer taking part
- Medisch Spectrum TwenteEnschede, HollandiaNo longer taking part
- Academisch Ziekenhuis MaastrichtMaastricht, HollandiaNo longer taking part
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, HollandiaNo longer taking part
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaNo longer taking part
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, HollandiaNo 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
- Universitair Medisch Centrum Utrecht
- Trial code
- EU 2024-510903-12-00
- Record updated
- 2024. szeptember 6.
- Original description
Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and imaging data that predict response to treatment with tofacitinib, in DMARD-naïve and DMARD non-responsive PsA patientsRead full original descriptionShow less
A stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA); TOFA-PREDICT
Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and imaging data that predict response to treatment with tofacitinib, in DMARD-naïve and DMARD non-responsive PsA patients
Inclusion: Age 18-75 years old; Meets CASPAR criteria for psoriatic arthritis; Disease duration of at least 8 weeks; Evidence of active arthritis based upon ≥2 swollen joints and ≥2 tender joints; Subjects are to discontinue active psoriasis treatment prior to being enrolled in the study.
Exclusion: Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before the current study begins and/or during study participation. Participation in any observational studies during study participation; Pregnant females, breastfeeding females, females of child-bearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least one ovulatory cycle after last dose of investigational product or females planning pregnancy. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study; Current or recent history of a severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholersterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease; Currently have pustular psoriasis only.