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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00810199
First received: December 16, 2008
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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 [RoActemra/Actemra]
Drug: methotrexate
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:

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 ]

Enrollment: 552
Study Start Date: March 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg iv every 4 weeks
Drug: methotrexate
>15mg po weekly
Placebo Comparator: 2 Drug: tocilizumab [RoActemra/Actemra]
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

  Show 137 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00810199     History of Changes
Other Study ID Numbers: MA21488, 2008-001847-20
Study First Received: December 16, 2008
Last Updated: May 13, 2013
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
Antirheumatic Agents
Methotrexate
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
 Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013