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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365001
Recruitment Status : Completed
First Posted : August 16, 2006
Last Update Posted : June 11, 2010
Information provided by:
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: tocilizumab [RoActemra/Actemra] Drug: Methotrexate Drug: Simvastatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
10mg/kg iv on day 8

Drug: Methotrexate
10-25mg po/week

Drug: Simvastatin
40mg po on days 1, 15 and 43

Active Comparator: 2 Drug: tocilizumab [RoActemra/Actemra]
10mg/kg iv on day 8

Drug: Methotrexate
10-25mg po/week

Primary Outcome Measures :
  1. Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. [ Time Frame: Days 1, 15 and 43 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00365001

United States, Alabama
Aniston, Alabama, United States, 36207
United States, Arizona
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, Florida
Jacksonville, Florida, United States, 32216
Palm Harbor, Florida, United States, 34684
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Nebraska
Omaha, Nebraska, United States, 68154
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Austin, Texas, United States, 78704
New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00365001     History of Changes
Other Study ID Numbers: WP18663
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors