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AVONEX® Combination Trial - "ACT"

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00112034
First received: May 27, 2005
Last updated: May 5, 2008
Last verified: May 2008

May 27, 2005
May 5, 2008
June 2003
June 2006   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT00112034 on ClinicalTrials.gov Archive Site
Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression
Same as current
Not Provided
Not Provided
 
AVONEX® Combination Trial - "ACT"
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Multiple Sclerosis, Relapsing-Remitting
  • Drug: Methotrexate
  • Drug: IV methylprednisolone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
May 2007
June 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112034
C-865
Not Provided
Dennis Cunningham, Associate Director, Medical Affairs, Biogen Idec
Biogen Idec
Not Provided
Principal Investigator: Jeffrey A. Cohen, MD The Cleveland Clinic
Biogen Idec
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP