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Recruitment of participants
underway for combination therapy study
Medical Update Memo
April 7, 2006
SUMMARY
Investigators are seeking participants for the first large-scale
clinical trial testing the combined use of interferon beta-1a
(Avonex®) and glatiramer acetate (Copaxone®) to treat
relapsing-remitting multiple sclerosis. Approximately 80 medical
centres in North America – including three in Canada –
are recruiting people who have relapsing-remitting MS for the
study, called the CombiRx trial. The combination therapy will
be compared to the use of either agent alone for a period of
36 months. All participants will receive at least one active
medication, and there will not be a placebo-only treatment
arm.
DETAILS
Investigators at three Canadian MS clinics are taking part
in the first large-scale clinical trial testing the combined
use of interferon beta-1a (Avonex®) and glatiramer acetate
(Copaxone®) to treat relapsing-remitting multiple sclerosis.
The clinics are located in Ottawa, Toronto and Calgary. (See
details below for enrolment and contact information.)
This study, called the CombiRx trial, will
compare the combined use of Avonex and Copaxone to the use
of either agent alone for a period of 36 months. All participants
will receive at least one active medication, and there will
not be a placebo-only treatment arm. The study is funded by
the NIH's National Institute of Neurological Disorders and
Stroke (USA). Lead investigator is Fred D. Lublin, MD (Mount
Sinai School of Medicine, New York, NY).
An important ancillary study to this trial
will examine genetic and other biological markers at baseline
and at least one additional point during the study. The hope
is that these biological markers will provide a means for identifying,
in the future, those people with more aggressive disease as
well as those who respond or fail to respond to therapy. Such
markers would have considerable value in the management of
MS.
Treatment with disease-modifying agents
can reduce future disease activity and improve quality of life
for many individuals with relapsing forms of MS. However, researchers
continue to explore whether using these agents in combination
can enhance their effectiveness. A previous, smaller pilot
trial of the combination therapy suggested it was safe and
warranted further study.
The primary objective of the study is to
determine whether this combination treatment is effective in
reducing relapse rates, when compared to treatment with either
drug alone. Secondary objectives are to determine the safety
and tolerability of this combination.
Eligibility for participation:
People eligible for participation include men and women 18-60
years of age with relapsing-remitting MS (a course of MS
in which clearly defined flare-ups are followed by complete
or partial recovery periods), who have experienced at least
two relapses in the previous three years and have never received
either agent.
Participants will be randomly assigned to
receive either 1) a combination of interferon beta-1a (30 micrograms
given as a once-a-week intramuscular injection) and glatiramer
acetate (20 milligrams injected subcutaneously once a day);
2) interferon beta-1a and an inactive placebo delivered subcutaneously;
or 3) glatiramer acetate and a placebo delivered intramuscularly.
Treatment is being administered for 36 months.
Individuals who meet the study criteria may contact the research
centres directly:
MS Clinic, St. Michael’s Hospital, Toronto – Chantal
Bidal, Research Coordinator, (416) 864-5176
MS Clinic, Ottawa Hospital – Dawn Carle, Research Coordinator,
(613) 737-8104
MS Clinic, Foothills Hospital, Calgary – Krista Warners,
Research Coordinator, (403) 944-4244
(With information from the National MS Society
(USA)
ASK MS Information System Code: 1.4.1.60.e
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy
but provides information to assist individuals in making their own decisions.
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