A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01272908
First received: January 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 7, 2011
January 7, 2011
Not Provided
August 2010   (final data collection date for primary outcome measure)
Overall incidence of Adverse Events for 48 weeks after initial treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Incidence of adverse events after re-treatment with MabThera [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients meeting American College of Rheumatology Criteria (ACR 20/50/70) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients meeting European League Against Rheumatism (EULAR) response rates [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Disease Activity Score (DAS28) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in American College of Rheumatology Criteria (ACR) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Health Assessment Questionnaire (HAQ) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)
Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: rituximab
1000 mg intravenously on Days 1 and 15
Experimental: Single arm
Intervention: Drug: rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 18-80 years of age
  • Moderate to severe active rheumatoid arthritis
  • Inadequate response to a single previous or current treatment with an anti-TNF agent
  • Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks

Exclusion Criteria:

  • Previous treatment with MabThera
  • Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
  • Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
  • Active infection, or history of serious or chronic infection
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Sweden
 
NCT01272908
ML20381
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2011

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