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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:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502853
First received: July 17, 2007
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: rituximab [MabThera/Rituxan]
Drug: Methotrexate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Synovitis, bone marrow edema and erosions, measured by MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Drug: Methotrexate
10-25mg/week

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502853

Locations
Italy
Genova, Italy, 16132
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502853     History of Changes
Other Study ID Numbers: ML21081
Study First Received: July 17, 2007
Last Updated: July 19, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Rituximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013