AVONEX® Combination Trial - "ACT" - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00112034

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 IV

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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Methotrexate Medrol veriderm Methylprednisolone Interferon beta 1a Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

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

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 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
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012