Trial Information

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

Status: No longer recruiting

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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Pharmacokinetics

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: November, 2005

Trial Registration Date: 08/16/2006

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:28:56 PM