AVONEX® Combination Trial - "ACT"

May 5, 2008 updated by: Biogen

A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monotherapy.

The purpose of this study is to determine the efficacy and safety of combination therapy with AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • MS Academic Coordinating Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 55, inclusive
  • Diagnosis of MS
  • A relapsing-remitting course
  • Expanded Disability Status Scale (EDSS) score 0.0-5.5 inclusive at Baseline
  • Currently receiving AVONEX® therapy
  • Treated with AVONEX® for at least 6 consecutive months prior
  • Breakthrough disease (clinical relapse or gadolinium-enhancing MRI lesion) during the prior 12 months, at least 6 months after initiating AVONEX therapy.

Exclusion Criteria:

  • History of cirrhosis, chronic hepatitis, or currently active hepatitis
  • History of poorly-controlled hypertension, diabetes mellitus, or peptic ulcer disease
  • History of aseptic bone necrosis, osteoporosis, or osteoporosis-related bone fracture
  • History of steroid-induced psychosis.
  • History of or abnormal laboratory results indicating significant illness
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity or intolerance to MTX, IVMP, or AVONEX®.
  • History of allergy to albumin
  • History of any episode of suicidal ideation or severe depression within 3 months of the Screening Visit.
  • History of seizure within 3 months prior to the Screening Visit.
  • Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
  • MS relapse with onset within 60 days prior to the Baseline Visit
  • Any metallic or electronic material or device in the body, or condition that precludes the subject from undergoing MRI with gadolinium administration
  • A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the Screening Visit
  • Abnormal blood tests, performed at the Screening Visit, which exceed any of the limits defined by the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Brain MRI lesion activity measured by the combined number of T2-hyperintense lesions at Month 12 that are new or enlarged since Baseline
effectiveness of AVONEX® and IVMP plus MTX in trying to reduce lesion activity on brain MRI

Secondary Outcome Measures

Outcome Measure
Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Principal Investigator: Jeffrey A. Cohen, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 27, 2005

First Submitted That Met QC Criteria

May 27, 2005

First Posted (Estimate)

May 30, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-865

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis, Relapsing-Remitting

Clinical Trials on Methotrexate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe