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AVONEX® Combination Trial - "ACT"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00112034
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : May 9, 2008
Sponsor:
Information provided by:
Biogen

Tracking Information
First Submitted Date  ICMJE May 27, 2005
First Posted Date  ICMJE May 30, 2005
Last Update Posted Date May 9, 2008
Study Start Date  ICMJE June 2003
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AVONEX® Combination Trial - "ACT"
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE
  • Drug: Methotrexate
  • Drug: IV methylprednisolone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
350
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00112034
Other Study ID Numbers  ICMJE C-865
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dennis Cunningham, Associate Director, Medical Affairs, Biogen Idec
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey A. Cohen, MD The Cleveland Clinic
PRS Account Biogen
Verification Date May 2008

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