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

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

This study has been completed.

Study NCT00262314 Information provided by EMD Serono

First Received on December 5, 2005. Last Updated on August 23, 2011 History of Changes

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
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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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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
Number of Participants [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 ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

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

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8. Primary:

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

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9. Primary:

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

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10. Primary:

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

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11. Primary:

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

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12. Primary:

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

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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 posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

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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Results Point of Contact:

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

No publications provided

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:	August 23, 2011
Health Authority:	United States: Food and Drug Administration