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AVONEX® Combination Trial - "ACT"

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Methotrexate (Drug); IV methylprednisolone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Jeffrey A. Cohen, MD, Principal Investigator, Affiliation: The Cleveland Clinic

Summary

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind

Primary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

MS Academic Coordinating Center, Cleveland, Ohio 44195, United States
Additional Information

Starting date: June 2003
Last updated: May 5, 2008

Page last updated: August 20, 2015

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