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Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients (RENEW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00262314
First received: December 5, 2005
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: May 21, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Multiple Sclerosis

  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
Trial Initiation Date: 17 October 2000 (date of first subject first visit). Trial Completion Date 15 July 2008 (date of last subject last visit). 46 centers enrolled at least one subject.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Novantrone Therapy Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached

Participant Flow:   Overall Study
    Novantrone Therapy
STARTED   509 [1] 
COMPLETED   172 [2] 
NOT COMPLETED   337 
Changing physicians                38 
Death                12 
Patient's decision                92 
Not specified                95 
Lost to Follow-up                70 
Administrative withdrawal                30 
[1] Patients with validated data who received at least 1 dose of Novantrone®
[2] Patients in the study for 5 years +/-3 months are considered to have completed the 5-year study



  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
Novantrone Therapy Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached

Baseline Measures
   Novantrone Therapy 
Overall Participants Analyzed 
[Units: Participants]
 509 
Age, Customized 
[Units: Participants]
 
<=18 years   0 
18 - 70 years   509 
Age 
[Units: Years]
Mean (Full Range)
 46 
 (19 to 68) 
Gender 
[Units: Participants]
 
Female   344 
Male   165 
Region of Enrollment 
[Units: Participants]
 
United States   509 


  Outcome Measures
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1.  Primary:   Congestive Heart Failure (Treatment Phase)   [ Time Frame: up to 36 months ]

2.  Primary:   Congestive Heart Failure (Annual Follow-Up Phase)   [ Time Frame: up to 5 years ]

3.  Primary:   Left Ventricular Ejection Fraction (Treatment Phase)   [ Time Frame: up to 36 months ]

4.  Primary:   Left Ventricular Ejection Fraction (Annual Follow-Up Phase)   [ Time Frame: up to 5 years ]

5.  Primary:   Serious Infections (Treatment Phase)   [ Time Frame: up to 36 months ]

6.  Primary:   Serious Infections (Annual Follow-Up Phase)   [ Time Frame: up to 5 years ]

7.  Primary:   IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)   [ Time Frame: up to 36 months ]

8.  Primary:   IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)   [ Time Frame: up to 5 years ]

9.  Primary:   Severe Neutropenia (Treatment Phase)   [ Time Frame: up to 36 months ]

10.  Primary:   Severe Neutropenia (Annual Follow-Up Phase)   [ Time Frame: up to 5 years ]

11.  Primary:   Clinical Relapses (Treatment Phase)   [ Time Frame: up to 36 months ]

12.  Primary:   Clinical Relapses (Annual Follow-Up Phase)   [ Time Frame: up to 5 years ]

13.  Primary:   Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses   [ Time Frame: up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  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: Fernando Dangond, M.D., Medical Responsible
Organization: EMD Serono, Inc.
phone: +1 781 681 2348



Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00262314     History of Changes
Obsolete Identifiers: NCT00016614
Other Study ID Numbers: 24293
19-297
Study First Received: December 5, 2005
Results First Received: May 21, 2010
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration