We hypothesize that tofacitinib 5 mg QD in combination with cobicistat 150 mg QD is bio-equivalent to tofacitinib 5 mg BID
ID
Bron
Verkorte titel
Aandoening
Rheumatoid Arthritis, Psoriatic Arthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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%.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that tofacitinib 5 mg QD in combination with cobicistat 150 mg QD is bio-equivalent to tofacitinib 5 mg BID
Onderzoeksopzet
• T1: First visit for PK curve sample collection (approx. 2 weeks)
• T2: Second visit for PK curve sample collection (4-6 weeks)
Onderzoeksproduct en/of interventie
tofacitinib QD with cobicistat QD
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7766 |
| CCMO | NL65634.091.18 |
| OMON | NL-OMON48994 |