A Study to Evaluate Rebif® New Formulation (IFN-beta-1a) in Relapsing Remitting Multiple Sclerosis - Full Text View

Sponsor:	Merck KGaA
Information provided by:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00441103

Purpose

Objectives:

Primary: To evaluate the efficacy of Rebif® New Formulation (RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.

Primary Endpoints: The primary endpoint is the difference between the number of combined unique (CU) active MRI lesions at Week 16 in the RNF group (Group 1) vs. the placebo group (Group 2).

Secondary Endpoints: The secondary endpoint is the difference in the mean number of combined unique (CU) active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 vs. Weeks 17 - 40 for the subjects randomized to Group 2.

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Rebif® New Formulation (IFN-beta-1a)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN-beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis Nuclear Scans

Drug Information available for: Interferon beta Interferon-beta Interferon beta 1a

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

Number of Combined Unique (CU) Active MRI Lesions at Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Efficacy - MRI, Neurological Examination, Safety - Incidence, Severity, and Relationship to the Study Drug of Treatment Emergent Adverse Events, Serious Adverse Events, Laboratory Abnormalities, and Binding and Neutralizing Antibodies to IFN-Beta-1a [ Time Frame: Various Timepoints ] [ Designated as safety issue: No ]
Information on the Primary MRI outcome is posted above. Safety information is included in the adverse events section but is not posted otherwise nor is information on neurological examinations, laboratory abnormalities, or immunological outcomes.

Secondary Outcome Measures:

To Evaluate the Efficacy of RNF by Comparing the Mean Number of Combined Unique (CU) Lesions Per Scan Per Subject Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Subjects, Originally Randomized to Placebo. [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]
Difference in Mean Number of CU Active Lesions Per Subject Per Scan in Originally Randomized Placebo Subjects, Over the Following Treatment Periods: Trial Day 1 Through Week 16, and Weeks 17 Through 40 [ Time Frame: 40 Weeks ] [ Designated as safety issue: No ]
These data are displayed in the outcome above

Enrollment:	180
Study Start Date:	December 2006
Study Completion Date:	February 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 RNF 44 mcg s.c. tiw for 40 weeks	Drug: Rebif® New Formulation (IFN-beta-1a) Rebif® New Formulation (RNF) 44 mcg s.c. tiw for up to 40 weeks. The dose of study medication will be titrated during the initial four-weeks of treatment. Subjects in Group 2 will be switched to RNF 44 mcg s.c. tiw at the end of the initial 16 weeks of treatment, starting a second titration with the same titration schedule as the initial one, while subjects initially assigned to RNF will after Week 16 continue to receive active treatment at the same dose throughout the whole study period, without any re-titration.
Placebo Comparator: 2 Matching placebo for 16 weeks, then RNF 44 mcg s.c. tiw for remaining 24 weeks	Drug: Rebif® New Formulation (IFN-beta-1a) Rebif® New Formulation (RNF) 44 mcg s.c. tiw for up to 40 weeks. The dose of study medication will be titrated during the initial four-weeks of treatment. Subjects in Group 2 will be switched to RNF 44 mcg s.c. tiw at the end of the initial 16 weeks of treatment, starting a second titration with the same titration schedule as the initial one, while subjects initially assigned to RNF will after Week 16 continue to receive active treatment at the same dose throughout the whole study period, without any re-titration.

Arms

Assigned Interventions

Placebo Comparator: 1

RNF 44 mcg s.c. tiw for 40 weeks

Drug: Rebif® New Formulation (IFN-beta-1a)

Rebif® New Formulation (RNF) 44 mcg s.c. tiw for up to 40 weeks. The dose of study medication will be titrated during the initial four-weeks of treatment. Subjects in Group 2 will be switched to RNF 44 mcg s.c. tiw at the end of the initial 16 weeks of treatment, starting a second titration with the same titration schedule as the initial one, while subjects initially assigned to RNF will after Week 16 continue to receive active treatment at the same dose throughout the whole study period, without any re-titration.

Placebo Comparator: 2

Matching placebo for 16 weeks, then RNF 44 mcg s.c. tiw for remaining 24 weeks

Drug: Rebif® New Formulation (IFN-beta-1a)

Rebif® New Formulation (RNF) 44 mcg s.c. tiw for up to 40 weeks. The dose of study medication will be titrated during the initial four-weeks of treatment. Subjects in Group 2 will be switched to RNF 44 mcg s.c. tiw at the end of the initial 16 weeks of treatment, starting a second titration with the same titration schedule as the initial one, while subjects initially assigned to RNF will after Week 16 continue to receive active treatment at the same dose throughout the whole study period, without any re-titration.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:

Males and females between 18 and 60 years of age Female subjects must Be neither pregnant nor breast-feeding Be menopausal or surgically sterile or use an effective contraception chemical or mechanical), for the duration of the study
Have RRMS according to the revised McDonald criteria 2005 (32)(APPENDIX C)
Have brain and/or spinal MRI with findings typical of MS
Have disease duration for > 12 months
Have disease activity characterized by at least one clinical event and one or more Gd-enhancing MRI lesions within the 6 months prior to randomization
Have score of </=5.5 on the EDSS
Be willing and able to comply with the protocol for the duration of the study
Have given written informed consent prior to any study-related procedure not part of the normal medical practice

Exclusion Criteria:

Have any disease other than MS that could better explain his/her signs and symptoms
Have complete transverse myelitis or bilateral optic neuritis
Receive or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and ACTH), or total lymphoid irradiation
Have received within 3 months prior to baseline any approved disease- modifying therapy for MS, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, any investigational drug, or experimental procedure
Have received within 30 days prior to baseline oral or systemic corticosteroids or ACTH

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441103

Sponsors and Collaborators

Merck KGaA

Investigators

Study Director:

Bettina Stubinski, MD

Merck Serono SA - Geneva, an affiliate of Merck KGaA Darmstadt, Germany

More Information

Additional Information:

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

Publications:

De Stefano N, Curtin F, Stubinski B, Blevins G, Drulovic J, Issard D, Shotekov P, Gasperini C. Rapid benefits of a new formulation of subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis. Mult Scler. 2010 Mar 3; [Epub ahead of print]

Responsible Party:	Bettina Stubinski, Medical Director, Merck Serono SA - Geneva an affiliate of Merck KGaA Darmstadt, Germany
ClinicalTrials.gov Identifier:	NCT00441103 History of Changes
Other Study ID Numbers:	27178, 2006-003037-32
Study First Received:	February 26, 2007
Results First Received:	May 20, 2010
Last Updated:	May 27, 2010
Health Authority:	Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Estonia: The State Agency of Medicine; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ethics Committee; Lithuania: State Medicine Control Agency - Ministry of Health; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Spain: Ministry of Health and Consumption; Switzerland: Swissmedic

Keywords provided by Merck KGaA:

Subjects with relapsing remitting multiple sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

Interferon-beta
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012