A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00365001
First received: August 15, 2006
Last updated: June 10, 2010
Last verified: June 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] Drug: Methotrexate Drug: Simvastatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. [ Time Frame: Days 1, 15 and 43 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic parameters for tocilizumab. [ Time Frame: Days 11, 22, 29 and 36. ] [ Designated as safety issue: No ]
- CRP, IL-6, sIL-6R changes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Completion Date: | April 2008 |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365001
Locations
| 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
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided by Hoffmann-La Roche
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00365001 History of Changes |
| Other Study ID Numbers: | WP18663 |
| Study First Received: | August 15, 2006 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Simvastatin Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Hypolipidemic Agents Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013