AVONEX® Combination Trial - "ACT"

NCT00112034 | Completed Phase 4

• 1 other identifier: C-865
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Relapsing-Remitting; AVONEX; Combination; Methotrexate; IV Methylprednisolone; IVMP; ACT; MTX

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

Interventions

Methotrexate DRUG

IV methylprednisolone DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

MS Academic Coordinating Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Methotrexate; Methylprednisolone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jeffrey A. Cohen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 27, 2005
• First Posted: May 30, 2005
• Study Start: June 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

US (1)