A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00106522

Purpose

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: tocilizumab Drug: Placebo Drug: Methotrexate	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients with ACR 20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs, ECGs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with ACR 50 and ACR 70 responses [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Mean changes in parameters of ACR core set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	499
Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Experimental	Drug: tocilizumab 4mg/kg iv every 4 weeks Drug: Methotrexate 10-25mg weekly
2: Experimental	Drug: tocilizumab 8mg/kg iv every 4 weeks Drug: Methotrexate 10-25mg weekly
3: Placebo Comparator	Drug: Placebo iv every 4 weeks Drug: Methotrexate 10-25mg weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
inadequate response to current anti-rheumatic therapies, including MTX;
inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
on stable MTX for at least 8 weeks before entering study;
patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
women who are pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106522

Show 169 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Publications indexed to this study:

Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. Epub 2008 Jul 14.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WA18062
Study First Received:	March 25, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00106522
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Signs and Symptoms
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009