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A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502853
First received: July 17, 2007
Last updated: October 7, 2013
Last verified: October 2013

July 17, 2007
October 7, 2013
October 2007
July 2010   (final data collection date for primary outcome measure)
Synovitis, bone marrow edema and erosions, measured by MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Synovitis, bone marrow edema and erosions after 6 months, measured by MRI.
Complete list of historical versions of study NCT00502853 on ClinicalTrials.gov Archive Site
  • Ritchie articular index, HAQ, DAS 28, laboratory markers of disease activity. [ Time Frame: Weeks 4, 12 and 24 after MabThera cycle ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Ritchie articular index, HAQ, DAS28, laboratory markers of disease activity, at weeks 4, 12 and 24 after MabThera cycle. Safety: AEs, laboratory parameters.
Not Provided
Not Provided
 
A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.
Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis.

This single arm study will measure the effect of MabThera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of 10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 4
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]
    1000mg iv on days 1 and 15
  • Drug: Methotrexate
    10-25mg/week
Experimental: 1
Interventions:
  • Drug: rituximab [MabThera/Rituxan]
  • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • rheumatoid arthritis for >=3 months and <=10 years;
  • inadequate response to methotrexate (12.5-25mg/week) for >=3 months;
  • evidence of erosive disease and/or clinical synovitis in a signal joint.

Exclusion Criteria:

  • autoimmune rheumatic diseases other than RA;
  • surgical operations on bones/joints in 12 weeks prior to baseline visit;
  • concomitant treatment with biologic agents;
  • previous treatment with more than one biologic agent approved for RA, or with cell-depleting therapies.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00502853
ML21081
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