A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00531817

Purpose

This 2 arm study will assess the safety and efficacy, with regard to reduction in signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with moderate to severe active rheumatoid arthritis, with an inadequate response to DMARDs. Patients will be randomized in a ratio of 2:1 to receive either tocilizumab 8mg/kg iv or placebo iv every 4 weeks; all patients will also receive stable antirheumatic therapy including permitted DMARDs. 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: Permitted DMARDs	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

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, Parallel Group Study to Evaluate the Effect of Tocilizumab Versus Placebo in Reducing the Signs and Symptoms of Rheumatoid Arthritis in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Number and percentage of patients with ACR 50 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number and percentage of patients with ACR 20/50/70, and mean change from baseline in DAS 28, RAPID, SF-12, FACIT-F, MOS sleep scale. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:

570

Study Start Date:

September 2007

Estimated Study Completion Date:

June 2009

Arms	Assigned Interventions
1: Experimental	Drug: tocilizumab 8mg/kg iv every 4 weeks Drug: Permitted DMARDs As prescribed
2: Placebo Comparator	Drug: Placebo iv every 4 weeks Drug: Permitted DMARDs As prescribed

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
active rheumatoid arthritis of >6 months duration;
receiving permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline.

Exclusion Criteria:

rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
major surgery within 8 weeks prior to screening or planned within 6 months following randomization;
unsuccessful treatment with a biologic agent, including an anti-TNF agent;
previous treatment with tocilizumab.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531817

Contacts

Contact: Please reference Study ID Number: ML21136	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 162 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:

ML21136

First Received:

September 18, 2007

Last Updated:

December 2, 2008

ClinicalTrials.gov Identifier:

NCT00531817

Health Authority:

United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 07, 2009