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: March 10, 2015
Last verified: March 2015
Results First Received: July 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: rituximab [MabThera/Rituxan]
Drug: Methotrexate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rituximab Plus (+) Methotrexate (MTX) Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg per week (mg/week) by mouth or parenterally. Nonresponsive participants (defined as Disease Activity Score Based on 28-Joint Count and C-Reactive Protein [DAS28-CRP] score of greater than [>]2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.

Participant Flow:   Overall Study
    Rituximab Plus (+) Methotrexate (MTX)  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population: all participants who received any part of an infusion of study drug.

Reporting Groups
  Description
Rituximab + MTX Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.

Baseline Measures
    Rituximab + MTX  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean (Standard Deviation)
  52.42  (15.681)  
Gender  
[units: participants]
 
Female     6  
Male     4  



  Outcome Measures
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1.  Primary:   Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score   [ Time Frame: Baseline, Week 4, and Week 24 ]

2.  Primary:   OMERACT RAMRIS Bone Edema Score   [ Time Frame: Baseline, Weeks 4 and 24 ]

3.  Primary:   OMERACT RAMRIS Erosion Score   [ Time Frame: Baseline, Week 4, and Week 24 ]

4.  Primary:   Early Enhancement Rate (REE)   [ Time Frame: Baseline, Weeks 4 and 24 ]

5.  Primary:   Relative Enhancement (RE) Score   [ Time Frame: Baseline, Weeks 4 and 24 ]

6.  Secondary:   Ritchie Articular Index Scores   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

7.  Secondary:   Health Assessment Questionnaire - Disability Index (HAQ-DI) Score   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

8.  Secondary:   Patient’s Global Assessment of Pain   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

9.  Secondary:   DAS28 Score   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

10.  Secondary:   Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

11.  Secondary:   C-Reactive Protein (CRP)   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

12.  Secondary:   Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

13.  Secondary:   Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

14.  Secondary:   Total Immunoglobulin (Ig) Concentrations   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

15.  Secondary:   Hematocrit Concentration (%)   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

16.  Secondary:   Percentage of Total B-lymphocytes   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

17.  Secondary:   Erosion Score - Right Hand   [ Time Frame: Baseline and Week 24 ]

18.  Secondary:   Erosion Score - Left Hand   [ Time Frame: Baseline and Week 24 ]

19.  Secondary:   Joint Space Narrowing - Right Hand   [ Time Frame: Baseline and Week 24 ]

20.  Secondary:   Joint Space Narrowing - Left Hand   [ Time Frame: Baseline and Week 24 ]

21.  Secondary:   X-Rays: Right Hand Total Score   [ Time Frame: Baseline and Week 24 ]

22.  Secondary:   X-Rays: Left Hand Total Score   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502853     History of Changes
Other Study ID Numbers: ML21081
Study First Received: July 17, 2007
Results First Received: July 16, 2014
Last Updated: March 10, 2015
Health Authority: Italy: Ethics Committee