Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis - Study Results

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:	Multiple Sclerosis
Intervention:	Biological: Interferon-beta-1a FBS-free/HSA-free

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 25 Jan 2005 and attended the last visit on 16 April 2007. Two hundred and eighty two participants were screened for enrollment and 260 were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening phase of up to 28 days before the start of interferon-beta-1a treatment. There were 47 centres in: Argentina (5), Australia (4),Canada (1), Denmark (1),Ireland (2), Israel (2), Lithuania(2), Russia (10), Spain (4), Sweden (1), UK (5) and US (10). 1 additional centre in Australia screened 1 participant who was not enrolled into the trial.

Reporting Groups

	Description
Rebif New Formulation (RNF) Cohort	Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week

Participant Flow: Overall Study

	Rebif New Formulation (RNF) Cohort
STARTED	260
COMPLETED	224 ^[1]
NOT COMPLETED	36
Adverse Event	15
Lost to Follow-up	1
Administration of plasmapheresis	1
Initiated mitoxantrone therapy	1
Lack of efficacy	1
Decided not to continue treatment	1
Patient non-compliance	1
Patient refused to continue	1
Patient refused to participate	1
Patient will	1
Patient's decision	1
Participation in MS vaccine study	1
Pregnancy	1
Pregnancy (Protocol violation)	2
Protocol violation	2
Patient refused to come back	1
The patient has refused	2
The patient has refused to visit site	1
Patient is to be administered copaxone	1

[1]	260 participants included in the Safety Population.207 completed treatment. 224 completed the trial

Baseline Characteristics

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Reporting Groups

	Description
Rebif New Formulation (RNF) Cohort	Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week

Baseline Measures

	Rebif New Formulation (RNF) Cohort
Number of Participants [units: participants]	260
Age [units: participants]
<=18 years	0
Between 18 and 65 years	260
>=65 years	0
Age [units: years] Mean ± Standard Deviation	34.9 ± 9.5
Gender [units: participants]
Female	186
Male	74
Region of Enrollment [units: participants]
Argentina	14
Australia	10
Canada	4
Denmark	4
Ireland	4
Israel	4
Lithuania	20
Russian Federation	134
Spain	13
Sweden	5
United Kingdom	23
United States	25

Outcome Measures

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1. Primary:

Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit. [ Time Frame: 96 weeks ]

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2. Secondary:

Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study [ Time Frame: 96 weeks ]

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3. Secondary:

Number of Participants With Binding Antibodies (BAb) at Week 96 [ Time Frame: 96 weeks ]

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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: SPONSOR shall have the right to publish or present any results or information, including the Study Results, arising in connection with the STUDY for any purposes. The INSTITUTION, its officers, agents, employees and affiliated entities shall not publish or use any results or information arising in connection with the STUDY, including the Study Results, for professional, research, training or other purposes without SPONSOR’s prior written consent.

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: Bettina Stubinski/Medical Responsible
Organization: Merck Serono SA
phone: +41224143396

Publications of Results:

Giovannoni G, Barbarash O, Casset-Semanaz F, Jaber A, King J, Metz L, Pardo G, Simsarian J, Sørensen PS, Stubinski B; RNF Study Group. Immunogenicity and tolerability of an investigational formulation of interferon-beta1a: 24- and 48-week interim analyses of a 2-year, single-arm, historically controlled, phase IIIb study in adults with multiple sclerosis. Clin Ther. 2007 Jun;29(6):1128-45.

Giovannoni G, Barbarash O, Casset-Semanaz F, King J, Metz L, Pardo G, Simsarian J, Sørensen PS, Stubinski B; Rebif New Formulation Study Group. Safety and immunogenicity of a new formulation of interferon beta-1a (Rebif New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results. Mult Scler. 2009 Feb;15(2):219-28. Epub 2008 Aug 28.

Responsible Party:	Susan Fischer, EMD Serono Inc
ClinicalTrials.gov Identifier:	NCT00110396 History of Changes
Other Study ID Numbers:	25632
Study First Received:	May 6, 2005
Results First Received:	April 30, 2010
Last Updated:	June 14, 2010
Health Authority:	United States: Food and Drug Administration