A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Tracking InformationStart Date ICMJE | |
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Primary Completion Date | |
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Current Primary Outcome Measures ICMJE (submitted: November 3, 2009) | DAS28 remission (<2.6) [ Time Frame: week 24 ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT01007435 on ClinicalTrials.gov Archive Site |
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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 ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis |
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Official Title ICMJE | Multi-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 |
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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 |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Rheumatoid Arthritis |
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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
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Study Arms / Comparison Groups | |
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Recruitment InformationEstimated Enrollment ICMJE | 1128 |
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Estimated Completion Date | August 2014 |
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Primary Completion Date | |
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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
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | United 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 |
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Administrative InformationNCT ID ICMJE | NCT01007435 |
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Responsible Party | Disclosures Group, Hoffmann-La Roche |
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Study ID Numbers ICMJE | WA19926, 2009-012759-12 |
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Study Sponsor ICMJE | Hoffmann-La Roche |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Clinical Trials | Hoffmann-La Roche | |
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Information Provided By | Hoffmann-La Roche |
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