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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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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