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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00754572

Purpose

This single arm, open-label study will assess the safety and efficacy with regard to reduction of signs and symptoms of treatment with tocilizumab in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexate 10-25mg weekly. 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: methotrexate	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single-Arm, Open-Label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients with an ACR50 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with ACR20/70 responses; change from baseline in ACR core set components; change in disease activity score (DAS28); categorical DAS28 responders; Quality of Life assessments. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Adverse events, clinical laboratory tests, physical exam including vital signs. [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2010

Arms	Assigned Interventions
1: Experimental	Drug: tocilizumab 8mg/kg iv, every 4 weeks Drug: methotrexate 10-25mg oral or parenteral weekly.

Eligibility

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

Criteria

Inclusion Criteria:

patients >=18 years with moderate to severe active RA for at least 6 months;
swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
inadequate response to stable dose of MTX;
patients of reproductive potential must be using a reliable means of contraception.

Exclusion Criteria:

rheumatic autoimmune disease other than RA;
patients with functional class IV RA;
diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
prior treatment failure with anti-tumor necrosis factor agent;
pregnant or breastfeeding women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754572

Contacts

Contact: Please reference Study ID Number: ML21530	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 72 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21530
Study First Received:	September 17, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00754572
Health Authority:	Peru: Amador Vargas Guerra

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