A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs


Tracking Information

First Received Date  ICMJEOctober 15, 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)		Quality of life: HAQ and EQ-5D scores [ Time Frame: every 4 weeks up to week 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00996203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 15, 2009)
  • Disease activity (DAS28), ACR and EULAR responses, CRP, ESR [ Time Frame: every 4 weeks up to week 24 ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs. laboratory parameters [ Time Frame: throughout study, laboratory assessments every 4 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Official Title  ICMJELocal Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)
Brief Summary

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJERheumatoid Arthritis
Intervention  ICMJE
  • Drug: tocilizumab
    8 mg/kg iv every 4 weeks for 24 weeks
  • Drug: DMARDs (disease-modifying antirheumatic drugs)
    stable doses at investigator's prescription
Study Arms / Comparison Groups1: Experimental
Interventions:
  • Drug: tocilizumab
  • Drug: DMARDs (disease-modifying antirheumatic drugs)

Recruitment Information

Estimated Enrollment  ICMJE200
Estimated Completion DateSeptember 2010
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • moderate to severe active rheumatoid arthritis of >/=6 months duration
  • inadequate clinical response to current non-biologic DMARDs
  • current DMARDs must be at stable dose for 8 weeks prior to study entry
  • oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for >/=4 weeks prior to screening

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA
  • history of or current inflammatory joint disease other than RA
  • previous treatment with any biologic DMARD
  • functional class IV as defined by the ACR classification
  • intra-articular or parenteral corticosteroids within 6 weeks prior to screening
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: ML22665888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00996203
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEML22665
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche