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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00365001

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 I

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:

MedlinePlus related topics: Drug Reactions Rheumatoid Arthritis

Drug Information available for: Methotrexate Simvastatin Atlizumab

U.S. FDA Resources

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

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 February 09, 2012