Long Term Study of Avonex Therapy Following a First Attack of Multiple
Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years | 0.001 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years
10 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Immediate Treatment Group | 58 Percent cumulative probability | 48–68 | 81 |
| Delayed Treatment Group | 69 Percent cumulative probability | 61–78 | 74 |
Immediate Treatment Group
Delayed Treatment Group
p = 0.001
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| All Study Participants | 0 | 0 | 2 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years
10 years
Other measures (3)
Annualized Relapse Rate
10 years
RelapsesNumber of Participants With an EDSS > 3.5 at Study Completion
10 years
Disability progressionThe Number of New or Enlarging MRI T2 Lesions at 10 Years
10 years
MRI lesions
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Arch Neurol · 2012
Background
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med. 2000 Sep 28;343(13):898-904. doi: 10.1056/NEJM200009283431301.Background
Kinkel RP, Kollman C, O'Connor P, Murray TJ, Simon J, Arnold D, Bakshi R, Weinstock-Gutman B, Brod S, Cooper J, Duquette P, Eggenberger E, Felton W, Fox R, Freedman M, Galetta S, Goodman A, Guarnaccia J, Hashimoto S, Horowitz S, Javerbaum J, Kasper L, Kaufman M, Kerson L, Mass M, Rammohan K, Reiss M, Rolak L, Rose J, Scott T, Selhorst J, Shin R, Smith C, Stuart W, Thurston S, Wall M; CHAMPIONS StuBackground
Simon JH, Kinkel RP, Kollman C, O'Connor P, Fisher E, You X, Hyde R; CHAMPIONS Investigators Group. Ten-year follow-up of the 'minimal MRI lesion' subgroup from the original CHAMPS Multiple Sclerosis Prevention Trial. Mult Scler. 2015 Apr;21(4):415-22. doi: 10.1177/1352458514547407. Epub 2014 Oct 24.Background
Kinkel RP, Laforet G, You X. Disease-related determinants of quality of life 10 years after clinically isolated syndrome. Int J MS Care. 2015 Jan-Feb;17(1):26-34. doi: 10.7224/1537-2073.2013-041.
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History
Started
Feb 2001
Main results due
Mar 2009
Finished
Mar 2009
Results posted
Sept 2017