Phase 4
Completed N=155
Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis
Multiple Sclerosis · Optic Neuritis · Transverse Myelitis · Acute Brainstem/Cerebellar Syndrome
Source: ClinicalTrials.gov NCT00179478 ↗
Enrolled (actual)
155
Serious AEs
—
Results posted
Sep 2017
Primary outcomePrimary: Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years — 58; 69 Percent cumulative probability — p=0.001
◆ Published Evidence
Established
97citations · ~7 / year
Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance.
Summary
The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.
Linked Publications
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Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years |
58; 69 | 0.001 sig |
| SECONDARY Annualized Relapse Rate |
0.16; 0.33 | 0.02 sig |
| SECONDARY Number of Participants With an EDSS > 3.5 at Study Completion |
7; 5 | 0.61 |
| SECONDARY The Number of New or Enlarging MRI T2 Lesions at 10 Years |
5; 7 | 0.50 |
Eligibility Criteria
Inclusion Criteria
- Previous participation in CHAMPS study
- Participation in a study site willing to participate in the CHAMPIONS10 extension study
- Willingness to enroll in the CHAMPIONS 10 extension
- Willingness to sign informed consent
Exclusion Criteria
- Discovery of an alternative neurological disorder other than MS as a cause of initial neurological symptoms
- A severe systemic disease with likely mortality within 3 years
Data sourced from ClinicalTrials.gov (NCT00179478) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.