No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid Arthritis, Psoriatic Arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bio-equivalence of tofacitinib BID and tofacitinib + cobicistat QD, defined as the relevant steady state pharmacokinetic parameters (average concentration at steady state (Cavg,ss )/Area Under the Curve (AUC0-24), the 90% confidence interval of the geometric mean ratio falling entirely between 75% and 125%.
Secondary outcome
Secondary parameters are safety, efficacy (DAS28-CRP) and patient preference.
Background summary
Tofacitinib, a JAK-inhibitor which is proven effective for the treatment of rheumatoid arthritis, is mainly metabolized by CYP3A4. Cobicistat is a selective CYP3A4 inhibitor, currently used as boosting drug for antiretroviral drugs. This research will investigate whether treatment with tofacitinib 5 mg QD in combination with cobicistat 150 mg QD is bio-equivalent to the standard treatment tofacitinib BID, in patients with rheumatoid arthritis.
Study objective
We hypothesize that tofacitinib 5 mg QD in combination with cobicistat 150 mg QD is bio-equivalent to tofacitinib 5 mg BID
Study design
• T1: First visit for PK curve sample collection (approx. 2 weeks)
• T2: Second visit for PK curve sample collection (4-6 weeks)
Intervention
tofacitinib QD with cobicistat QD
Inclusion criteria
• Rheumatoid arthritis (either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion)
• Patients using tofacitinib for ≥ 2 weeks in the standard dose of 5mg BID. In addition, for patients that have used tofacitinib >3 months, it is required that a good response is achieved defined as a DAS28-CRP < 2.9 or the judgement of the rheumatologist that disease activity is low.
• Patient informed consent, ≥16 years old and mentally competent
• Ability to measure the outcome of the study in this patient (e.g. patient availability; willing and being able to undergo repeated serum samples)
• Ability to read and communicate well in Dutch
Exclusion criteria
• Concomitant use of inducers or potent inhibitors of CYP3A4 or moderate inhibitors of CYP3A4 and potent inhibitors of CYP2C19, or medication sensitive to changes in metabolism as a result of cobicistat co-treatment, as assessed with the KNMP “G-standaard” unless an alternative is listed in Table 1.
• Known contra-indications for treatment with cobicistat in line with the summary of product characteristics.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7766 |
| CCMO | NL65634.091.18 |
| OMON | NL-OMON48994 |