At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 155 enrolled

Drug / intervention

interferon beta 1a 30 ug IM once weeklydrug

Likely dose

Interferon beta-1a 30 µg intramuscularly once weeklyAI-extracted

Key inclusion· 3

✓Previous participation in CHAMPS study
✓Willingness to enroll in the CHAMPIONS 10 extension
✓Participation in a study site willing to participate in the CHAMPIONS10 extension study

Key exclusion· 2

✕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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00179478

NCT00179478Phase 4Completed

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Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)

Beth Israel Deaconess Medical Center·interventional·Posted Sep 16, 2005·Updated Sep 6, 2017

In Brief

A Phase 4 clinical trial evaluating interferon beta 1a 30 ug IM once weekly for Multiple Sclerosis and 3 related conditions. Completed, enrolled 155 participants across 26 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMultiple Sclerosis, Optic Neuritis, Transverse Myelitis, Acute Brainstem/Cerebellar Syndrome

CountriesCanada, United States

CollaboratorsBiogen

Timeline

Phase 4CompletedFinished

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2001

First PostedSep 2005

Primary CompletionMar 2009

TodayJul 2026

First PostedSep 16, 2005

Enrollment StartFeb 1, 2001

Primary CompletionMar 1, 2009

TodayJul 2, 2026

Enrollment to primary: 8.1 yearsPosted 20.8 years ago

Interventions

interferon beta 1a 30 ug IM once weeklydrug

Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.