A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

Roche

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Simvastatin; Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365001

WP18663

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Methotrexate

Drug: Simvastatin

Drug: tocilizumab [RoActemra/Actemra]

2

Active Comparator group

Treatment:

Drug: Methotrexate

Drug: tocilizumab [RoActemra/Actemra]