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A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502996
First received: July 17, 2007
Last updated: August 22, 2016
Last verified: August 2016
Results First Received: June 29, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Methotrexate
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
A total of 246 participants were enrolled in study conducted from 20 February 2006 to 05 December 2008 across 56 study centers in 10 Latin American countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 246 participants, fourteen did not receive study drug and were not included in analysis population.

Reporting Groups
  Description
Rituximab Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.

Participant Flow:   Overall Study
    Rituximab
STARTED   232 
COMPLETED   188 
NOT COMPLETED   44 
Lost to Follow-up                9 
Protocol Violation                2 
Treatment failure                25 
Withdrawal Informed Consent                6 
Adverse Event                2 



  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.
The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.

Reporting Groups
  Description
Rituximab Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.

Baseline Measures
   Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 232 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.6  (12.2) 
Gender 
[Units: Participants]
 
Female   207 
Male   25 


  Outcome Measures
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1.  Primary:   Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death   [ Time Frame: Up to Week 48 ]

2.  Primary:   Number of Participants With AEs According to Degree of Intensity   [ Time Frame: Up to Week 48 ]

3.  Primary:   Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs   [ Time Frame: Up to Week 48 ]

4.  Primary:   Number of Participants With AEs of Special Interest During the Study   [ Time Frame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48) ]

5.  Secondary:   Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

6.  Secondary:   Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

7.  Secondary:   Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

8.  Secondary:   Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

9.  Secondary:   Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

10.  Secondary:   Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

11.  Secondary:   Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

12.  Secondary:   Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

13.  Secondary:   Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit   [ Time Frame: Screening (Days -28 to 0) and EOT (Week 24) ]

14.  Secondary:   Mean Duration of Morning Joint Stiffness   [ Time Frame: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48) ]

15.  Secondary:   Mean Value of Painful Joints   [ Time Frame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48) ]

16.  Secondary:   Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria   [ Time Frame: Week 1, Week 12, and Week 24 ]

17.  Secondary:   Mean Value of Quality of Life (Health Assessment Questionnaire – Disease Index)   [ Time Frame: Screening (Days -28 to 0), Week 1, Week 12, and Week 24 ]

18.  Secondary:   Mean Values of C Reactive Protein   [ Time Frame: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48) ]

19.  Secondary:   Mean Values of Globular Sedimentation Velocity   [ Time Frame: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24 ]

20.  Secondary:   Mean Values of Pain and Activity Based on Visual Analogue Scale   [ Time Frame: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24 ]

21.  Secondary:   Mean Value of Inflamed Joints   [ Time Frame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48) ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 61 6878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502996     History of Changes
Other Study ID Numbers: ML19385
Study First Received: July 17, 2007
Results First Received: June 29, 2016
Last Updated: August 22, 2016
Health Authority: Mexico: Ministry of Health