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  ICMJENovember 2007
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 HistoryComplete list of historical versions of study NCT00576433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 18, 2008)
  • Safety of re-treatment (AEs) [ Time Frame: For 24 weeks after re-treatment. ] [ Designated as safety issue: No ]
  • Laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT. [ Time Frame: For 48 weeks after initial treatment. ] [ Designated as safety issue: No ]
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  ICMJEA Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Official Title  ICMJEAn 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 PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJERheumatoid Arthritis
Intervention  ICMJE
  • Drug: rituximab [MabThera/Rituxan]
    1000mg iv on days 1 and 15
  • Drug: Methotrexate
    As prescribed
Study Arms / Comparison Groups1: Experimental
Interventions:
  • Drug: rituximab [MabThera/Rituxan]
  • Drug: Methotrexate

Recruitment Information

Estimated Enrollment  ICMJE100
Estimated Completion DateJune 2011
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • moderate to severe active rheumatoid arthritis;
  • inadequate response to previous or current treatment with 1 anti-TNF agent;
  • receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.

Exclusion Criteria:

  • previous treatment with MabThera;
  • use of an anti-TNF alpha agent within 8 weeks of study start;
  • concurrent treatment with any DMARD other than methotrexate;
  • active infection, or history of serious recurrent or chronic infection.
GenderBoth
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: ML21271888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00576433
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEML21271
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche