Clinical trial NCT00112034: AVONEX® Combination Trial - "ACT"
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Relapsing-Remitting
AVONEX
Combination
Methotrexate
IV Methylprednisolone
IVMP
ACT
MTX
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2005-05-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.


Eligibility 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.

Primary outcomes:
measure: Brain MRI lesion activity measured by the combined number of T2-hyperintense lesions at Month 12 that are new or enlarged since Baseline
measure: effectiveness of AVONEX® and IVMP plus MTX in trying to reduce lesion activity on brain MRI
Secondary outcomes:
measure: Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MS Academic Coordinating Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jeffrey A. Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: