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


Tracking Information

Start Date  ICMJEMarch 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
DAS28 remission rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00810199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 16, 2008)
  • 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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA 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
Official Title  ICMJERandomized 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...
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJERheumatoid Arthritis
Intervention  ICMJE
  • Drug: tocilizumab
    8mg iv every 4 weeks
  • Drug: methotrexate
    >15mg po weekly
  • Drug: placebo
    po weekly
Study Arms / Comparison Groups
  • 1: Experimental
    Interventions:
    • Drug: tocilizumab
    • Drug: methotrexate
  • 2: Placebo Comparator
    Interventions:
    • Drug: tocilizumab
    • Drug: placebo

Recruitment Information

Estimated Enrollment  ICMJE470
Estimated Completion DateFebruary 2012
Primary Completion Date 
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: MA21488888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEUnited States,   Brazil,   Croatia,   Denmark,   Estonia,   France,   Germany,   Greece,   Israel,   Italy,   Latvia,   Monaco,   Netherlands,   Norway,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Thailand,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00810199
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEMA21488, 2008-001847-20
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche