Chronotherapy in Inflammatory Arthritis (ChronIA trial): a randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- 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

Exclusion Criteria

- Current or previous treatment of arthritis with tsDMARD(s)
- Prednisone (or equivalent) usage at a dose of >7.5mg
- Work in shifts
- (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)
- Unable to understand, speak and write in Dutch.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the difference in self-reported disease activity,<br /><br>measured with the Routine Assessment of Patient Index Data 3 (RAPID-3), between<br /><br>morning and evening dosing of tofacitinib XR after 3 months of treatment.</p><br>

Secondary Outcome Measures