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: September 3, 2014
Last verified: September 2014
Results First Received: June 4, 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
Intervention: Drug: rituximab [MabThera/Rituxan]

  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 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 milligrams (mg) weekly; participants may also have been receiving a stable dose of folic acid. Participants with Disease Activity Score Based on 28 Joint Count (DAS28) greater than or equal to (≥)2.6 and an improvement in DAS28 greater than (>0.6) 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.

Participant Flow:   Overall Study
    Rituximab Plus Methotrexate (MTX)  
STARTED     193  
COMPLETED     93  
NOT COMPLETED     100  
Adverse Event                 5  
Additional or changed therapy                 48  
Lack of Efficacy                 11  
Protocol Violation                 4  
Withdrawal by Subject                 5  
Lost to Follow-up                 6  
Administrative problems                 1  
Not specified                 20  



  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 at least 1 dose of the trial medication and had at least 1 safety follow-up, whether withdrawn prematurely or not. A safety follow-up was assumed if the participant had at least 1 documented study visit after baseline or if at least 1 adverse event had been documented with start date after baseline.

Reporting Groups
  Description
Rituximab Plus MTX Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.

Baseline Measures
    Rituximab Plus MTX  
Number of Participants  
[units: participants]
  193  
Age  
[units: years]
Mean ( Full Range )
  55.5  
  ( 26 to 78 )  
Gender  
[units: participants]
 
Female     146  
Male     47  



  Outcome Measures
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1.  Primary:   Change From Baseline in DAS28 Score at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   DAS28 Score by Treatment Course and Follow-up (FU) Visit   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

3.  Secondary:   Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course   [ Time Frame: Week 24 ]

4.  Secondary:   Percentage of Participants Achieving a Response By EULAR Category and Treatment Course   [ Time Frame: Week 24 ]

5.  Secondary:   Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

6.  Secondary:   Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

7.  Secondary:   Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

8.  Secondary:   SF-36 MCS by Treatment Course   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

9.  Secondary:   SF-36 Domain Scores by Treatment Course - Physical Functioning   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

10.  Secondary:   SF-36 Domain Scores by Treatment Course - Bodily Pain   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

11.  Secondary:   SF-36 Domain Scores by Treatment Course - Physical Role Functioning   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

12.  Secondary:   SF-36 Domain Scores by Treatment Course - Emotional Role Functioning   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

13.  Secondary:   SF-36 Domain Scores by Treatment Course - Emotional Well-Being   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

14.  Secondary:   SF-36 Domain Scores by Treatment Course - Social Functioning   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

15.  Secondary:   SF-36 Domain Scores by Treatment Course - Vitality   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

16.  Secondary:   SF-36 Domain Scores by Treatment Course - General Heath Perceptions   [ Time Frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 ]

17.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course   [ Time Frame: 24 weeks after each course ]

18.  Secondary:   Swollen Joint Count   [ Time Frame: Screening and Week 24 ]

19.  Secondary:   Tender Joint Count   [ Time Frame: Screening and Week 24 ]

20.  Secondary:   Physician's Global Assessment of Disease Activity   [ Time Frame: Baseline and Week 24 ]

21.  Secondary:   Patient's Global Assessment of Disease Activity   [ Time Frame: Baseline and Week 24 ]

22.  Secondary:   Patient's Assessment of Pain   [ Time Frame: Baseline and Week 24 ]

23.  Secondary:   C-Reactive Protein   [ Time Frame: Baseline and Week 24 ]

24.  Secondary:   Erythrocyte Sedimentation Rate   [ Time Frame: Baseline and Week 24 ]

25.  Secondary:   Rheumatoid Factor (RF)   [ 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: NCT00502840     History of Changes
Other Study ID Numbers: ML19071
Study First Received: July 17, 2007
Results First Received: June 4, 2014
Last Updated: September 3, 2014
Health Authority: Germany: Paul-Ehrlich-Institut