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COMPLETED Phase 4

Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis

NCT00179478 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG interferon beta 1a 30 ug IM once weekly

Study Locations (20)

Pennsylvania

  • The Neurology Group — Norristown
  • Univeristy of Pennsylvania Medical Center — Philadelphia
  • Allegheny Neurological Associates — Pittsburgh

New York

  • Jacobs Neurological Institute — Buffalo
  • University of Rochester — Rochester

Ohio

  • Cleveland Clinic Foundation — Cleveland
  • The Ohio State University — Columbus

Virginia

  • Virginia Commonwealth University/Medical College of Virginia — Richmond
  • Neurological Associates, Inc. — Richmond

Connecticut

  • MS Treatment Center at Griffin Hospital — Derby

Florida

  • Jaeb Center for Health Research — Tampa

Georgia

  • MS Center of Atlanta — Atlanta

Illinois

  • Beta Research, Inc — Elk Grove

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2001-02
Est. Completion 2009-03
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00179478

The ClinicalTrials.gov registry entry for NCT00179478 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention — of which interferon beta 1a 30 ug IM once weekly is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00179478 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Pennsylvania, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00179478 about?

NCT00179478 is a clinical study titled "Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis". 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...

What is the current status of trial NCT00179478?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 155 participants. The study started on 2001-02. Estimated completion is 2009-03.

What conditions does trial NCT00179478 study?

This clinical trial studies the following conditions: Multiple Sclerosis, Optic Neuritis, Transverse Myelitis, Acute Brainstem/Cerebellar Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00179478?

The interventions under investigation include: interferon beta 1a 30 ug IM once weekly (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00179478?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00179478 being conducted?

This trial has 20 study locations across Connecticut, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial