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Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: Interferon beta 1-a (Drug); glatiramer acetate (Drug); placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Fred Lublin

Official(s) and/or principal investigator(s):
Fred Lublin, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai


This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).

Clinical Details

Official title: A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: ARR - PDEs

Secondary outcome:

Confirmed Progression on the Expanded Disability Status Scale

Change in the Multiple Sclerosis Functional Composite

Change in MRI Composite Score

Detailed description: This is a multicenter, double blind, randomized trial examining combination therapy versus single agent therapy with three-year follow-up on the last patient randomized. All patients will remain on therapy until the last patient completes the study. All patients will then be transitioned, based on the findings, to open label of combination with continued follow-up or some recommendation about single agent therapy. While the study design benefits from having two arms of single agent therapy to examine the important question of whether there are differences between the single agents, the primary interest is in combination therapy.

Therefore, a two-group combination versus single agent concept was used - splitting the

population into single agent and combination therapy equally. The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN intramuscularly (IM) and GA subcutaneously (SC) (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- Male and female subjects between the ages of 18 and 60 years, inclusive.

- Diagnosis of relapsing-remitting MS by either the Poser or McDonald criteria.

- Expanded Disability Status Scale (EDSS) score between 0 and 5. 5, inclusive.

- At least 2 exacerbations in the prior three years; one exacerbation may utilize the

McDonald MRI criteria for dissemination in time (a new gadolinium [Gd]-enhancing lesion demonstrated on a scan done at least 3 months following onset of a clinical attack or a new T2 lesion or Gd-enhancing lesion on a follow-up scan after an additional 3 months).

- Give written informed consent prior to any testing under this protocol, including

screening tests and evaluations that are not considered part of the subject's routine care. Exclusion Criteria:

- Any prior use of interferon beta or glatiramer acetate.

- Acute exacerbation within 30 days of screening.

- Steroids for acute exacerbations (>100 mg/day) within 30 days of study entrance or

chronic systemic steroid use.

- Evidence of progressive MS.

- Use IVIg, azathioprine, methotrexate, cyclosporine, mitoxantrone, cyclophosphamide,

mycophenolate (CellCept) or plasma exchange in the twelve weeks prior to study drug dosing.

- Any previous treatment with natalizumab (Tysabri, Antegren), cladribine, T cell

vaccine, Campath, daclizumab, rituximab, altered peptide ligand or total lymphoid irradiation.

- Treatment with 4 aminopyridines in the four weeks prior to study drug dosing.

- Prior treatment with any other investigational drug, unless approved by the Clinical

Coordinating Center (Dr. Lublin).

- Inability to perform the baseline MSFC (timed 25-foot walk, 9-hole peg test [9HPT],

and Paced Auditory Serial Addition Test 3 [PASAT3]).

- Inability to undergo baseline MRI scan.

- History of any significant cardiac, hepatic, pulmonary, or renal disease, immune

deficiency, or other medical conditions that would preclude therapy with interferon beta, glatiramer acetate, or participation in this study.

- Known history of sensitivity to gadopentetate dimeglumine or mannitol.

- History of a seizure within the 3 months prior to randomization.

- History of suicidal ideation or an episode of severe depression within the 3 months

prior to randomization.

- Abnormal screening blood tests exceeding any of the limits defined below:

- Alanine transaminase (ALT) or aspartate transaminase (AST) greater than two

times the upper limit of normal (i. e., >2 × ULN)

- Total white blood cell count <2,300/mm3

- Platelet count <80,000/mm3

- Creatinine >2 × ULN

- Participation in another experimental clinical trial, without formal approval.

- History of alcohol or drug abuse within the 2 years prior to randomization.

- Female subjects who are currently pregnant, breast-feeding, or plan to become


- For female subjects, unless postmenopausal or surgically sterile, unwillingness to

practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception.

- Unwillingness or inability to comply with the requirements of this protocol including

the presence of any condition that is likely to affect the subject's returning for scheduled follow-up visits on schedule (any physical, mental, or social condition).

Locations and Contacts

University of Alabama - Birmingham, Birmingham, Alabama, United States

Foothills Medical Centre, Calgary, Alberta, Canada

Capital Health and the University of Alberta, Edmonton, Alberta, Canada

Barrow Neurology Clinic, Phoenix, Arizona, United States

Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States

Northwest Neurospecialists PLLC, Tucson, Arizona 85741, United States

Sutter East Bay Medical Group, Berkeley, California, United States

Neurology Center North Orange County, La Habra, California, United States

VA West Los Angeles Healthcare Center, Los Angeles, California, United States

University of California - Davis Medical Center, Sacramento, California 95817, United States

Alpine Clinical Research Center, Boulder, Colorado, United States

Patricia Fodor P.C., Colorado Springs, Colorado, United States

University of Colorado Health Sciences Center, Denver, Colorado, United States

Yale University School of Medicine, New Haven, Connecticut, United States

Neurology Associates, PA, Maitland, Florida, United States

University of Miami - Neurology, Miami, Florida 33124, United States

MS Center of Atlanta, Atlanta, Georgia, United States

Shepherd Center, Atlanta, Georgia, United States

Northwest University, Chicago, Illinois, United States

Consultants in Neurology - Multiple Sclerosis Center, Northbrook, Illinois, United States

University of Illinois College of Medicine, Peoria, Illinois, United States

Ruan Neurology Clinic and Research Center, Des Moines, Iowa, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

Maryland Center for MS, Baltimore, Maryland, United States

Tufts-New England Medical Center, Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center, Boston, Massachusetts, United States

Lahey Clinic, Burlington, Massachusetts, United States

Wayne State University, Detroit, Michigan, United States

Michigan State University, East Lansing, Michigan, United States

Minneapolis Clinic - MS Center, Golden Valley, Minnesota, United States

Mayo Clinic - Rochester, Rochester, Minnesota, United States

St. Louis University - St. Louis VA, St. Louis, Missouri, United States

Washington University School of Medicine, St. Louis, Missouri, United States

Northern Rockies MS Center, Billings, Montana, United States

Dartmouth Medical School, Lebanon, New Hampshire, United States

CentraState Medical Center, Freehold, New Jersey, United States

University of New Mexico, Albuquerque, New Mexico, United States

Albany Medical College, Albany, New York, United States

Neuro Associates of Albany, PC, Albany, New York 12208, United States

The Jacobs Neurological Institute, Buffalo, New York, United States

Winthrop Neurology Faculty Practice, Mineola, New York, United States

Columbia University Medical Center, New York, New York 10032, United States

Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States

NYU Hospital For Joint Diseases, New York, New York, United States

South Shore Neurologic Associates Inc., Patchogue, New York, United States

University of Rochester, Rochester, New York, United States

SUNY Upstate Medical University, Syracuse, New York, United States

CMC-Neuroscience & Spine Institute, Division of Neurology, MS Center, Charlotte, North Carolina, United States

Meritcare Neuroscience, Fargo, North Dakota, United States

NeuroCare Center, Inc., Canton, Ohio, United States

Cleveland Clinic, Cleveland, Ohio, United States

Ohio State University, Columbus, Ohio, United States

Neurology Specialists, Dayton, Ohio 45415, United States

Medical College Of Ohio, Toledo, Ohio, United States

Oak Clinic for Multiple Sclerosis, Uniontown, Ohio, United States

Ottawa Hospital, Ottawa, Ontario, Canada

St. Michael's Hospital-Multiple Sclerosis Research Center, Toronto, Ontario, Canada

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Allegheny MS Treatment Center, Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Baylor College of Medicine, Houston, Texas, United States

University of Texas - Houston, Houston, Texas, United States

University of Utah, Salt Lake City, Utah, United States

Neurological Research Center, Inc., Bennington, Vermont, United States

Fletcher Allen Health Care, Burlington, Vermont, United States

Neurological Associates, Inc., Richmond, Virginia, United States

Virginia Commonwealth University, Richmond, Virginia, United States

MS Center at Evergreen, Seattle, Washington, United States

Virginia Mason Medical Center, Seattle, Washington, United States

Marshfield Clinic, Marshfield, Wisconsin, United States

Regional MS Center at St. Luke's Medical Center, Milwaukee, Wisconsin, United States

Additional Information

Starting date: January 2005
Last updated: March 6, 2014

Page last updated: August 20, 2015

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