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Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)

This study has been terminated.
(The efficacy on CSF biomarkers failed to reach criteria for continuation of the trial)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01212094
First received: September 29, 2010
Last updated: March 9, 2016
Last verified: March 2016
Results First Received: March 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Drug: Rituximab
Other: normal saline

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject received an open label study drug under a compassionate use amendment of the protocol. This subject is not reflected in the data analysis for the primary or secondary outcome measures.

Reporting Groups
  Description
Baseline Patients in their first year baseline prior to study drug phase
Placebo Group administered placebo
Rituximab Group administered active drug

Participant Flow for 2 periods

Period 1:   Year 1: Baseline Monitoring
    Baseline     Placebo     Rituximab  
STARTED     43     0     0  
COMPLETED     27     0     0  
NOT COMPLETED     16     0     0  
Study terminated                 7                 0                 0  
Withdrawal by Subject                 7                 0                 0  
Started on DMT                 2                 0                 0  

Period 2:   Years 2 & 3: Treatment Randomization
    Baseline     Placebo     Rituximab  
STARTED     0     9     18  
COMPLETED     0     5     7  
NOT COMPLETED     0     4     11  
Study terminated                 0                 4                 7  
Withdrawal by Subject                 0                 0                 3  
Adverse Event                 0                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Placebo Group administered placebo
Rituximab Group administered active drug
Baseline Patients in their first year baseline prior to treatment phase
Total Total of all reporting groups

Baseline Measures
    Placebo     Rituximab     Baseline     Total  
Number of Participants  
[units: participants]
  9     18     16     43  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     9     18     16     43  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     2     9     11     22  
Male     7     9     5     21  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     3     0     1     4  
White     6     18     13     37  
More than one race     0     0     1     1  
Unknown or Not Reported     0     0     1     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration   [ Time Frame: 3 months ]

2.  Primary:   Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration   [ Time Frame: 3 months ]

3.  Secondary:   Analysis of Changes in CSF B Cell Numbers Between Rituximab and Placebo   [ Time Frame: 3 months ]

4.  Secondary:   Expanded Disability Status Scale (EDSS)   [ Time Frame: 24 months ]

5.  Secondary:   Scripps Neurological Rating Scale (NRS)   [ Time Frame: 24 months ]

6.  Secondary:   Timed 25 Foot Walk   [ Time Frame: 24 months ]

7.  Secondary:   9-Hole Peg Test   [ Time Frame: 24 months ]

8.  Secondary:   Multiple Sclerosis Functional Composite (MSFC)   [ Time Frame: 24 months ]

9.  Secondary:   EDSS   [ Time Frame: 0 months ]

10.  Secondary:   Scripps Neurological Rating Scale (NRS)   [ Time Frame: 0 Months ]

11.  Secondary:   Timed 25 Foot Walk   [ Time Frame: 0 months ]

12.  Secondary:   9-Hole Peg Test   [ Time Frame: 0 months ]

13.  Secondary:   Multiple Sclerosis Functional Composite (MSFC)   [ Time Frame: 0 Months ]


  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
The trial was closed prematurely for futility, because pre-determined interim analysis demonstrated that selected dosing led to <50% depletion of B cells from the brain/spinal cord. Therefore, only 5 patients per group finished trial.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Bibiana Bielekova, Prinicipal Investigator
Organization: NINDS, NIH
phone: 301-402-4488
e-mail: bibiana.bielekova@nih.gov


Publications of Results:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01212094     History of Changes
Other Study ID Numbers: 100212
10-N-0212
Study First Received: September 29, 2010
Results First Received: March 9, 2016
Last Updated: March 9, 2016
Health Authority: United States: Food and Drug Administration