AVONEX® Combination Trial - "ACT"

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112034
• Other study ID #: C-865
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2005
• Last updated: May 5, 2008
• Start date: June 2003
• Est. completion date: May 2007

Study information

• Verified date: May 2008
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Intervention

Drug:
• Methotrexate

• IV methylprednisolone

Locations

Country	Name	City	State
United States	MS Academic Coordinating Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain MRI lesion activity measured by the combined number of T2-hyperintense lesions at Month 12 that are new or enlarged since Baseline
Primary	effectiveness of AVONEX® and IVMP plus MTX in trying to reduce lesion activity on brain MRI
Secondary	Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression