AVONEX® Combination Trial - "ACT"

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00112034
First received: May 27, 2005
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Methotrexate
Drug: IV methylprednisolone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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:
  • Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression

Estimated Enrollment: 350
Study Start Date: June 2003
Study Completion Date: May 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112034

Locations
United States, Ohio
MS Academic Coordinating Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Jeffrey A. Cohen, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Dennis Cunningham, Associate Director, Medical Affairs, Biogen Idec
ClinicalTrials.gov Identifier: NCT00112034     History of Changes
Other Study ID Numbers: C-865
Study First Received: May 27, 2005
Last Updated: May 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Multiple Sclerosis
Relapsing-Remitting
AVONEX
Combination
Methotrexate
IV Methylprednisolone
IVMP
ACT
MTX

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methotrexate
Interferon beta 1a
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 18, 2014