Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS

NCT02419638 | Withdrawn DMC

• 1 other identifier: 2015P000242
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.

Conditions

Multiple Sclerosis

Keywords

relapsing-remitting MS; lesions; treatment

Outcome Measures

Primary Outcomes (1)

• T2 lesion load: Rebif v. Tecfidera

  To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.

  6 months

Secondary Outcomes (1)

• Reducing lesion load and MRI characteristics: Rebif v. Tecfidera

  6 months

Study Arms (2)

Randomized Treatment Arm: Rebif

120 patients treated with Rebif (IFN β-1a subcutaneous three times per week)

Drug: Rebif (IFN β-1a subcutaneous three times per week)

Randomized Treatment Arm: Tecfidera

120 patients treated with Tecfidera (dimethyl fumarate)

Drug: Tecifdera (dimethyl fumarate)

Interventions

Rebif (IFN β-1a subcutaneous three times per week) DRUG

Randomized Treatment Arm: Rebif

Tecifdera (dimethyl fumarate) DRUG

Randomized Treatment Arm: Tecfidera

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a single center study conducted at the Partners Multiple Sclerosis Center. Patients who are planning to start a new disease modifying treatment for relapsing-remitting MS will be offered enrollment in this study of two commonly used MS treatments by their treating physician. Potential subjects will undergo inclusion/exclusion review by the study nurse. Those meeting criteria will be enrolled by overall study PI or treating physician. Subjects will be identified from the Partners MS Center at the Brigham and Women's Hospital. Potential subjects will initially be approached by their treating physician concerning the study.

You may qualify if:

• Male and female subjects aged 18-65 years old, inclusive.
• A diagnosis of MS as defined by the McDonald 2010 criteria for MS.
• Relapsing form of MS, defined as at least one relapse in the prior 5 years.
• Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.
• English language skills adequate for the completion of questionnaires and cognitive measures.

You may not qualify if:

• Subjects with progressive MS.
• Subjects with a contraindications for standard treatment with Rebif or Tecfidera including GI disease, needle phobia, liver disease.
• Subjects treated with:
• High dose intravenous immunoglobulin within 2 months prior to study entry
• Natalizumab within 3 months prior to study entry
• Immunosuppressive/immunomodulatory medications including cyclophosphamide, mitoxantrone, azathioprine, methotrexate, rituximab, ofatumumab, ocrelizumab, or alemtuzumab at any time.
• Subjects with absolute lymphocyte count \< 800 cells (mm3).
• Subjects with any of the following neurologic/psychiatric disorder:
• Severe depression during the past 12 months before screening;
• History of substance abuse (treatment or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
• Subjects unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA.
• Pregnant or nursing females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test.
• Female subjects of childbearing potential, defined as all females physiologically capable of becoming pregnant, unless they agree to abstinence or, if sexually active, the use of contraception.
• History of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.
• Subjects with abnormal Liver Function Test (LFT) levels

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• EMD Serono: collaborator

Study Sites (1)

Partners MS Center, 1 Brookline Place Suite 225

Brookline, Massachusetts, 02445, United States

Location

Related Publications (10)

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• Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998 Nov 7;352(9139):1498-504.

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• Kappos L, Gold R, Miller DH, Macmanus DG, Havrdova E, Limmroth V, Polman CH, Schmierer K, Yousry TA, Yang M, Eraksoy M, Meluzinova E, Rektor I, Dawson KT, Sandrock AW, O'Neill GN; BG-12 Phase IIb Study Investigators. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Oct 25;372(9648):1463-72. doi: 10.1016/S0140-6736(08)61619-0.

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  PMID: 15389896 BACKGROUND

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  PMID: 11836778 BACKGROUND

• Liu L, Meier D, Polgar-Turcsanyi M, Karkocha P, Bakshi R, Guttmann CR. Multiple sclerosis medical image analysis and information management. J Neuroimaging. 2005;15(4 Suppl):103S-117S. doi: 10.1177/1051228405282864.

  PMID: 16385023 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a; Dimethyl Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Neurologist, Assoc. Professor of Neurology

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

US (1)