A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis

NCT00441103 | Completed Phase 3 Results

• 2 other identifiers: 271782006-003037-32
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes. Objectives: Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], 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 CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2). Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Subjects with relapsing remitting multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16

  CU active lesions were defined as a unique newly active or persistently active lesion on the protocol density/time constant 2 (PD/T2) scan or the gadolinium (Gd-) enhanced time constant 1 (T1) scan (with a method to avoid double counting).

  16 Weeks

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs were categorized based upon the treatment period during which they occurred, that is, double-blind period (up to Week 16) and rater-blind period (Week 17 up to Week 40).

  Baseline up to Week 40

Secondary Outcomes (2)

• Mean Number of CU Lesions Per Scan Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Participants, Originally Randomized to Placebo.

  Day 1 up to Week 16 and Week 17 up to Week 40

• Number of CU Active MRI Lesions

  Up to Week 40

Study Arms (2)

Rebif® New Formulation (IFN-beta-1a, RNF)

EXPERIMENTAL

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

Placebo/RNF

PLACEBO COMPARATOR

Drug: Placebo; Drug: Rebif® New Formulation (IFN-beta-1a, RNF)

Interventions

Rebif® New Formulation (IFN-beta-1a, RNF) DRUG

RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.

Also known as: IFN-beta-1a

Rebif® New Formulation (IFN-beta-1a, RNF)

Placebo DRUG

Matching placebo will be administered subcutaneously three times a week for 16 weeks.

Placebo/RNF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females between 18 and 60 years of age
• Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study
• Have Relapsing Remitting Multiple Sclerosis (RRMS) according to the revised McDonald criteria 2005
• Have brain and/or spinal MRI with findings typical of Multiple Sclerosis (MS)
• Have disease duration for more than 12 months
• Have disease activity characterized by at least one clinical event and one or more Gadolinium-enhancing MRI lesions within the 6 months prior to randomization
• Have score of \<=5.5 on the Expanded Disability Status Scale (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

You may not qualify if:

• Have any disease other than MS that could better explain his/her signs and symptoms
• Have complete transverse myelitis or bilateral optic neuritis
• Have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone \[ACTH\]), 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Related Publications (3)

• De Stefano N, Curtin F, Stubinski B, Blevins G, Drulovic J, Issard D, Shotekov P, Gasperini C; IMPROVE Study Investigators. Rapid benefits of a new formulation of subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis. Mult Scler. 2010 Jul;16(7):888-92. doi: 10.1177/1352458510362442. Epub 2010 Mar 3.

  PMID: 20200197 RESULT

• De Stefano N, Sormani MP, Stubinski B, Blevins G, Drulovic JS, Issard D, Shotekov P, Gasperini C. Efficacy and safety of subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis: further outcomes from the IMPROVE study. J Neurol Sci. 2012 Jan 15;312(1-2):97-101. doi: 10.1016/j.jns.2011.08.013. Epub 2011 Aug 31.

  PMID: 21880336 RESULT

• Giorgio A, Battaglini M, Gentile G, Stromillo ML, Gasperini C, Visconti A, Paolillo A, De Stefano N. Mapping the Progressive Treatment-Related Reduction of Active MRI Lesions in Multiple Sclerosis. Front Neurol. 2020 Nov 20;11:585296. doi: 10.3389/fneur.2020.585296. eCollection 2020.

  PMID: 33329329 DERIVED

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

peginterferon beta-1a

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Bettina Stubinski, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 28, 2007
• Study Start: December 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: July 9, 2014
• Results First Posted: July 5, 2010

Record last verified: 2014-06