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A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00106548
First received: March 25, 2005
Last updated: June 10, 2010
Last verified: June 2010

March 25, 2005
June 10, 2010
Not Provided
Not Provided
Percentage of patients with ACR 20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00106548 on ClinicalTrials.gov Archive Site
  • Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
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A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: tocilizumab [RoActemra/Actemra]
    4mg/kg iv / month
  • Drug: tocilizumab [RoActemra/Actemra]
    8mg/kg iv / month
  • Drug: Placebo
    iv / month
  • Drug: Methotrexate
    10-25mg/week
  • Experimental: 1
    Interventions:
    • Drug: tocilizumab [RoActemra/Actemra]
    • Drug: Methotrexate
  • Experimental: 2
    Interventions:
    • Drug: tocilizumab [RoActemra/Actemra]
    • Drug: Methotrexate
  • Placebo Comparator: 3
    Interventions:
    • Drug: Placebo
    • Drug: Methotrexate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
623
October 2007
Not Provided

Inclusion Criteria:

  • adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
  • inadequate response to a stable dose of MTX;
  • patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

  • major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
  • prior treatment failure with an anti-tumor necrosis factor agent;
  • women who are pregnant or breast-feeding.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Brazil,   Bulgaria,   Canada,   China,   France,   Germany,   Hungary,   Israel,   Italy,   Mexico,   Singapore,   Slovakia,   Switzerland,   Thailand
 
NCT00106548
WA17822
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP