A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502840
First received: July 17, 2007
Last updated: October 7, 2013
Last verified: October 2013

July 17, 2007
October 7, 2013
July 2007
September 2011   (final data collection date for primary outcome measure)
Change of DAS 28 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Change of DAS28 in week 24 achieved by re-treatment. Change from course specific baseline and original course baseline.
Complete list of historical versions of study NCT00502840 on ClinicalTrials.gov Archive Site
  • ACR 20/50/70, HAQ, SF-36, FACIT-F, TJC, SJC, CRP, BSG, RF. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: ACR 20/50/70, HAQ, SF-36, FACIT-F, TJC, SJC, CRP, BSG, RF achieved in week 24 by re-treatment. Safety: AEs.
Not Provided
Not Provided
 
A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).

This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

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 [MabThera/Rituxan]
1g iv on days 1 and 15
Experimental: 1
Intervention: Drug: rituximab [MabThera/Rituxan]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit;
  • eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).

Exclusion Criteria:

  • patients who have withdrawn from treatment in ML19070 pre-week 16;
  • patients with a previous response in DAS28 <0.6 to MabThera after week 16;
  • concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00502840
ML19071
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

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