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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00365001
First received: August 15, 2006
Last updated: June 10, 2010
Last verified: June 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014