Background: Interferon-β1a (IFNB) and glatiramer acetate (GA) are distinct therapies which are both partially effective for relapsing MS. It is not known if combining the two treatments would be more effective. Objective: To review the rationale, design, and baseline characteristics of the CombiRx study of combined treatment with IFNB and GA. Methods: The key inclusion criteria included a diagnosis of relapsing MS, at least 2 episodes of MS activity in the previous 3 years, expanded disability status scale of 05.5, and no prior treatment with either IFNB or GA. Subjects were randomized to IFNBGA, IFNB monotherapy, or GA monotherapy in a 2:1:1 ratio. Results: From 2005 to 2009, we enrolled 1008 subjects. The participants were 72.4% female and 87.6% Caucasian with a mean age of 37.7 years. The median duration of symptoms was 2 years at entry into the study, and the mean EDSS was 2.1. On the baseline MRI, the mean total lesion load was 12.2 ml, and 40% of the participants had enhancing lesions. Conclusion: We have recruited a population of patients with clinical and MRI characteristics typical for early MS. The study results will aid in deciding on the optimum early treatment. This trial should serve as a model for future studies of combination therapy.
Bibliographical noteFunding Information:
The study is funded by The National Institutes of Health , The National Institute of Neurological Disorders and Stroke (Phase III study: UO1 NS045719 , Planning Grant: R21 NS41986 ) and is listed on www.clinicaltrials.gov NCT00211887 . Materials were provided to the study by Biogen Idec and Teva Pharmaceutical. Contrast Letter Acuity funding provided by the National Multiple Sclerosis Society. We would like to thank Theresa McVie, MS, for assistance with preparation of tables and data analysis; CCC, SDMC, and MRI-AC staff; the following site investigators and staff who have enrolled participants: M. Agius, Sacramento, CA; K. Bashir, Birmingham, AL; R. Baumhefner, Los Angeles, CA; G. Birnbaum, Golden Valley, MN; G. Blevins, Edmonton, AB Canada; R. Bomprezzi, Phoenix, AZ; A. Boster, Columbus, OH; T. Brown, Kirkland, WA; J. Burkholder, Canton, OH; A. Camac, Lexington, MA; D. Campagnolo, Phoenix, AZ; J. Carter, Scottsdale, AZ; B. Cohen, Chicago, IL; J. Cooper, Berkeley, CA; J. Corboy, Aurora, CO; A. Cross, Saint Louis, MO; L. Dewitt, Salt Lake City, UT; J. Dunn, Kirkland, WA; K. Edwards, Latham, NY; E. Eggenberger, East Lansing, MI; J. English, Atlanta, GA; W. Felton, Richmond, VA; P. Fodor, Colorado Springs, CO; C. Ford, Albuquerque, NM; M. Freedman, Ottawa, Ontario, Canada; S. Galetta, Philadelphia, PA; G. Garmany, Boulder, CO; A. Goodman, Rochester, NY; M. Gottesman, Mineola, NY; C. Gottschalk, New Haven CT; M. Gruental, Albany, NY; M. Gudesblatt, Patchogue, NY; R. Hamill, Burlington, VT; J. Herbert, New York, NY; R. Holub, Albany, NY; W. Honeycutt, Maitland, FL; B. Hughes, Des Moines, IA; G. Hutton, Houston, TX; D. Jacobs, Philadelphia, PA; K. Johnson, Baltimore, MD; L. Kasper, Lebanon, NH; J. Kattah, Peoria, IL; M. Kaufman, Charlotte, NC; M. Keegan, Rochester, NY; O. Khan, Detroit, MI; B. Khatri, Milwaukee, WI; M. Kita, Seattle, WA; B. Koffman, Toledo, OH; E. Lallana, Lebanon, NH; N. Lava, Albany, NY; J. Lindsey, Houston, TX; P. Loge, Billings, MT; S. Lynch, Kansas City, KS; F. McGee, Richmond, VA; L. Mejico, Syracuse, NY; L. Metz, Calgary, AB Canada; P. O'Connor, Toronto, ON, Canada; K. Pandey, Albany, NY; H. Panitch, Burlington, VT; J. Preiningerova, New Haven, CT; K. Rammohan, Columbus, OH; C. Riley, New Haven, CT; P. Riskind, Worcester, MA; L. Rolak, Marshfield, WI; W. Royal, Baltimore, MD; S. Scarberry, Fargo, ND; A. Schulman, Richmond, VA; T. Scott, Pittsburgh, PA; C. Sheppard, Uniontown, OH; W. Sheremata, Miami, FL; L. Stone, Cleveland, OH; W. Stuart, Atlanta, GA; S. Subramaniam, Nashville, TN; V. Thadani, Lebanon, NH; F. Thomas, Saint Louis, MO; B. Thrower, Atlanta, GA; M. Tullman, New York, NY; A. Turel, Danville, PA; T. Vollmer, Phoenix, AZ; S. Waldman, La Habra, CA; B. Weinstock-Guttman, Buffalo, NY; J. Wendt, Tucson, AZ; R. Williams, Billings, MT; D. Wynn, Northbrook, IL; M. Yeung, Calgary, AB Canada.
The study was funded by the National Institutes of Health with medications and matched placebos provided by Biogen Idec and Teva Pharmaceuticals. Design, analysis, and decision to publish results are the responsibility of the CCC, SDMC, MRI-AC. Additional funding was provided by the NINDS NIH Intramural Program for the Biomarker MS ancillary study and the National Multiple Sclerosis Society for the Contrast Sensitivity ancillary project. The trial is listed on www.clincaltrials.gov , NCT00211887.
- Clinical trial
- Combination therapy
- Glatiramer acetate
- Interferon beta-1a
- Multiple sclerosis