Taking people in NetherlandsPhase 4
Comparing morning and evening tofacitinib dosing in rheumatoid and psoriatic arthritis
Compares morning and evening timing of tofacitinib doses in adults with arthritis.
Key facts
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Where
- Capelle aan den IJssel and Rotterdam, NetherlandsSee the 2 sites
- Trial code
- EU 2024-517865-17-01
- EudraCT 2021-004131-84
- ISRCTN68663074
- Registry title
- Comparing the effectiveness of tofacitinib extended release (XR) chronotherapy, morning versus evening dosing, in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients from a patient's, clinical as well as a translational point of view.
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 84 people, planned
- Started
- 30 Sept 2024
- Planned end
- 30 Oct 2026
- Type of study
- Interventional
- Record updated
- 30 September 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active rheumatoid arthritis or psoriatic arthritis who have not been treated with tsDMARDs. It compares taking tofacitinib XR in the morning with taking it in the evening.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Rheumatoid arthritis or psoriatic arthritis with active disease: DAS>2.4 for rheumatoid arthritis or DAPSA>14 for psoriatic arthritis
- Earlier treatment
- No current or previous treatment of arthritis with tsDMARDs. Prednisone (or equivalent) must not be above 7.5mg.
Main reasons for not taking part
- Current or previous treatment of arthritis with tsDMARDs
- Prednisone (or equivalent) at a dose above 7.5mg
- Working in shifts
- Pregnant or breastfeeding women
- Unable to understand, speak and write in Dutch
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- RA or PsA, , according to respectively the ACR/EULAR 2010 criteria for RA and CASPAR criteria
- Active disease, respectively defined as a DAS>2.4 or DAPSA>14
- Age ≥18 years
Who cannot take part
- Current or previous treatment of arthritis with tsDMARD(s)
- (Relative) contraindications for study medication:a. Evidence of ongoing infectious or malignant process obtained within 3 months prior to screening and evaluated by a qualified health care professional. b. Pregnant or nursing (lactating) women. c. Female participants of child bearing potential and male participants whose partner is of child bearing potential who are not willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter as in standard practice. d. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria: Any single parameter may not exceed 2 x upper limit of normal (ULN). A single parameter elevated up to and including 2 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to enrolment/randomization, to rule out laboratory error. e. History of renal trauma, glomerulonephritis, or subjects with one kidney only, or a glomerular filtration rate (GFR) < 30 ml/min. f. Other underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy. g. Use of powerful CYP3A4 inhibitors (e.g. ketoconazole, fluconazole, tacrolimus and ciclosporin)
- Prednisone (or equivalent) usage at a dose of >7.5mg
- Work in shifts
- Unable to understand, speak and write in Dutch
Where in Netherlands
- IJsselland ZiekenhuisCapelle aan den IJssel, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
About the trial
What the trial wants to find out
The primary outcome is the difference in self-reported disease activity, measured with the Routine Assessment of Patient Index Data 3 (RAPID-3), between morning and evening dosing of tofacitinib XR after 3 months of treatment.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Chronotherapy in Inflammatory Arthritis (ChronIA trial): a randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release
- Plain-language title
- Comparing morning and evening tofacitinib dosing in rheumatoid and psoriatic arthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 30 September 2024