A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, August 2009

First Received: December 16, 2008 Last Updated: August 26, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00810199

Purpose

This 2 arm study will compare 2 treatment strategies based on tocilizumab and/or methotrexate in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a)tocilizumab 8mg iv every 4 weeks + methotrexate po weekly or b)tocilizumab 8mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is 2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: tocilizumab Drug: methotrexate Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

DAS28 remission rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Inhibition of progressive joint damage [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
ACR20/50/70/90 response, and time to response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
DAS, DAS28, HAQ [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	470
Study Start Date:	March 2009
Estimated Study Completion Date:	January 2012

Arms	Assigned Interventions
1: Experimental	Drug: tocilizumab 8mg iv every 4 weeks Drug: methotrexate >15mg po weekly
2: Placebo Comparator	Drug: tocilizumab 8mg iv every 4 weeks Drug: placebo po weekly

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;
moderate to severe active rheumatoid arthritis (DAS28 >4.4);
inadequate response to methotrexate;
on a stable dose of >=15mg/week methotrexate for at least 6 weeks.

Exclusion Criteria:

prior treatment with a biologic;
RA functional class IV;
known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
evidence of active malignant disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810199

Contacts

Contact: Please reference Study ID Number: MA21488	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 138 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MA21488, 2008-001847-20
Study First Received:	December 16, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00810199 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Folate
Rheumatic Diseases
Folinic Acid
Folic Acid Antagonists

Immunosuppressive Agents
Vitamin B9
Folic Acid
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 03, 2009