Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Pat
Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS
What it found
The trial ended early for another reason (see below).
Reason given: Collaborative decision between study PI and sponsor.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
T2 lesion load: Rebif v. Tecfidera
6 months
MRI lesions
Other measures (1)
Reducing lesion load and MRI characteristics: Rebif v. Tecfidera
6 months
MRI lesionsBrain volume loss
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
1. Male and female subjects aged 18-65 years old, inclusive. 2. A diagnosis of MS as defined by the McDonald 2010 criteria for MS. 3. Relapsing form of MS, defined as at least one relapse in the prior 5 years. 4. Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive. 5. English language skills adequate for the completion of questionnaires and cognitive measures.
Exclusion criteria
1. Subjects with progressive MS. 2. Subjects with a contraindications for standard treatment with Rebif or Tecfidera including GI disease, needle phobia, liver disease. 3. 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. 4. Subjects with absolute lymphocyte count \< 800 cells (mm3). 5. 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; 6. Subjects unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA. 7. 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. 8. 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. 9. History of hypersensitivity to any of the study treatments or to treatments of similar chemical classes. 10. Subjects with abnormal Liver Function Test (LFT) levels
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Klawiter EC, Cross AH, Naismith RT. The present efficacy of multiple sclerosis therapeutics: Is the new 66% just the old 33%? Neurology. 2009 Sep 22;73(12):984-90. doi: 10.1212/WNL.0b013e3181b9c8f7.Background
Freedman MS, Hughes B, Mikol DD, Bennett R, Cuffel B, Divan V, LaVallee N, Al-Sabbagh A. Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: a systematic comparison. Eur Neurol. 2008;60(1):1-11. doi: 10.1159/000127972. Epub 2008 Apr 25.Background
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.Background
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. 2008Background
Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328.Background
Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Meltzer L, Kurukulasuriya NC. Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). Mult Scler. 2015 Jan;21(1):57-66. doi: 10.1177/1352458514537013. Epub 2014 Jul 2.Background
Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. doi: 10.1056/NEJMoa1114287.Background
Rudick RA, Lee JC, Simon J, Ransohoff RM, Fisher E. Defining interferon beta response status in multiple sclerosis patients. Ann Neurol. 2004 Oct;56(4):548-55. doi: 10.1002/ana.20224.Background
Wei X, Warfield SK, Zou KH, Wu Y, Li X, Guimond A, Mugler JP 3rd, Benson RR, Wolfson L, Weiner HL, Guttmann CR. Quantitative analysis of MRI signal abnormalities of brain white matter with high reproducibility and accuracy. J Magn Reson Imaging. 2002 Feb;15(2):203-9. doi: 10.1002/jmri.10053.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.
Loading reviews and guidelines…
Related trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dime
Phase 3 · Not yet recruiting
Still running
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Phase 3 · Not yet recruiting
Still running
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting
Still running
- Observational Study of Persistence on Bafiertam Treatment in Routine C
Stopped early
Stopped
- A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Scle
Phase 4 · Completed
No results found
- Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Di
Running, not recruiting
Still running
History
Started
May 2015
Main results due
Dec 2015
Finished
Feb 2016