NL-OMON26019
Completed
Not Applicable
Pharmaco-enhancement in Rheumatoid Arthritis with Cobicistat to dose Tofacitinib In Clinic Adequately Low. A within-subject sequential study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Sponsor
- Radboudumc
- Enrollment
- 30
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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