Trial information
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Status: Completed
Protocol number: WP18663
Sponsor: Hoffman-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to assess the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab in patients with rheumatoid arthritis.
Brief summary: This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 24.
Study phase: I
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Pharmacokinetics study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: tocilizumab
Primary outcome: 1. Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. Time frame: Days 1, 15 and 43
Key secondary outcomes: 1. Pharmacokinetic parameters for tocilizumab. Time frame: Days 11, 22, 29 and 36.
2. CRP, IL-6, sIL-6R changes Time frame: Throughout study
3. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-75 years of age;
- rheumatoid arthritis for >=6 months;
- methotrexate for >=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).
Exclusion criteria:
- history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA;
- concurrent treatment with any DMARD other than methotrexate;
- prior treatment with tocilizumab.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 08/16/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Scottsdale, AZ
- Oklahoma City, OK
- Duncansville, PA
- Austin, TX
