TOFACITINIB for Rheumatoid arthritis | Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- RA or PsA, , according to respectively the ACR/EULAR 2010 criteria for RA and CASPAR criteria\n- Active disease, respectively defined as a DAS>2.4 or DAPSA>14\n- Age ≥18 years"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured with the Routine Assessment of Patient Index Data 3 (RAPID-3); comparison between morning versus evening dosing after 3 months of treatment."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints are: (self-reported) disease activity (states); morning stiffness; general health; fatigue; pain; sleep; functional ability; quality of life; worker productivity; treatment satisfaction; and compliance.","definition_or_measurement_approach":""}
• {"endpoint_text":"- In addition, we will investigate whether the expression of circadian clock genes and microbiota composition change over time and whether these changes correlate with treatment response.","definition_or_measurement_approach":"Investigation of changes in expression of circadian clock genes and microbiota composition over time and correlation analyses with treatment response."}

Netherlands

Earliest CTIS Part Ii Submission Date

26-09-2024

Latest Decision Or Authorization Date

30-09-2024

Processing Time Days

4

Number Of Sites

2

Number Of Participants

84

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Pfizer B.V.","duties_or_roles":"Source of monetary support","organisation_type":""}