2024-510903-12-00CompletedPhase 4
TOFA-PREDICT
A stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA); TOFA-PREDICT
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Sept 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 28 May 2024
- Start date
- 30 May 2018
- Lead sponsor
- Universitair Medisch Centrum Utrecht
- Diseases
- Psoriatic arthritis
- EU CT number
- 2024-510903-12-00
- EudraCT number
- 2017-003900-28
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 160
- 6 sites 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
- 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.
Other illness
- Current or recent history of a severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholersterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease.
Other
- Currently have pustular psoriasis only
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stichting Reade | Amsterdam | Netherlands | Completed |
| Medisch Spectrum Twente | Enschede | Netherlands | Completed |
| Academisch Ziekenhuis Maastricht | Maastricht | Netherlands | Completed |
| Stichting Elisabeth-TweeSteden Ziekenhuis | Tilburg | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Completed |
| Stichting Viecuri Medisch Centrum voor Noord-Limburg | Venlo | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.