A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis 


Tracking Information

Start Date  ICMJE 
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2009)		DAS28 remission (<2.6) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01007435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 3, 2009)
  • change in total modified Sharp score [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • clinical response: ACR20/ACR50/ACR70 [ Time Frame: weeks 24 and 52 ] [ Designated as safety issue: No ]
  • physical function: HAQ-DI score [ Time Frame: weeks 24 and 52 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Official Title  ICMJEMulti-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission & Prevention of Structural Joint Damage During Treatment With Tocilizumab as a Monotherapy & in Combination With Methotrexate Versus Methotrexate in Pts With Early Moderate to Severe Rheumatoid Arthritis
Brief Summary

This randomized, double-blind, parallel group study will assess the safety, disease remission and prevention of structural joint damage on treatment with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate in patients with early moderate to severe rheumatoid arthritis. Patients will be randomized to receive either A) tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or B) tocilizumab (8mg/kg iv every 4 weeks) plus methotrexate (7.5-20mg po weekly), or C) tocilizumab (4mg/kg iv every 4 weeks) plus methotrexate (7.5-20mg po weekly), or D) placebo plus methotrexate (7.5-20mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks and target sample size is >1'000 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/kg iv every 4 weeks
  • Drug: tociliumab
    4mg/kg iv every 4 weeks
  • Drug: methotrexate
    7.5-20mg po weekly
Study Arms / Comparison Groups
  • A: Experimental
    Intervention: Drug: tocilizumab
  • B: Experimental
    Interventions:
    • Drug: tocilizumab
    • Drug: methotrexate
  • C: Experimental
    Interventions:
    • Drug: tociliumab
    • Drug: methotrexate
  • D: Active Comparator
    Intervention: Drug: methotrexate

Recruitment Information

Estimated Enrollment  ICMJE1128
Estimated Completion DateAugust 2014
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • rheumatoid arthritis of </=2 years duration
  • DAS28 >3.2
  • SJC >/=4, TJC >/=6
  • RF and/or anti-CCP positive (if RF and anti-CCP negative >1 erosion required at screening)
  • ESR >/=28mm/h or CRP >/=10mg/L at screening

Exclusion Criteria:

  • previous treatment with tocilizumab
  • previous treatment with methotrexate or biologic agent
  • rheumatic autoimmune disease other than RA
  • history of or current inflammatory joint disease other than RA
  • functional class IV
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: WA19926888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Brazil,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Macedonia, The Former Yugoslav Republic of,   Mexico,   New Zealand,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Thailand,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT01007435
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEWA19926, 2009-012759-12
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche