A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
Tracking Information
Start Date ICMJE | November 2007 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: January 18, 2008) | AEs, including infusion-related adverse events [ Time Frame: For 48 weeks after initial treatment ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: December 18, 2007) | Incidence of adverse events, including infusion-related adverse events, for 48 weeks after initial treatment. |
Change History | Complete list of historical versions of study NCT00576433 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: January 18, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: December 18, 2007) | Safety: Safety of re-treatment with MabThera for 24 weeks (AEs); lab assessments, vital signs. Efficacy: ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT, up to 48 weeks after initial treatment. |
Descriptive Information
Brief Title ICMJE | A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor. |
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Official Title ICMJE | An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor |
Brief Summary | This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals. |
Detailed Description | |
Study Phase | Phase IV |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Rheumatoid Arthritis |
Intervention ICMJE |
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Study Arms / Comparison Groups | 1: Experimental Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 100 | ||||
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Estimated Completion Date | June 2011 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00576433 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | ML21271 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/