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Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate
This study has been terminated.
( lack of efficacy of the prednisone/placebo )

First Received on September 13, 2005.   Last Updated on February 1, 2012   History of Changes
Sponsor: Teva Pharmaceutical Industries
Information provided by (Responsible Party): Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00203047
  Purpose

This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Glatiramer Acetate
Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate the add-on treatment effect of oral steroids on brain volume changes as measured by the 3-year change from baseline in brain volume, in relapsing remitting multiple sclerosis subjects treated with GA. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 414
Study Start Date: January 2005
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Glatiramer Acetate
    20mg GA administered by daily subcutaneous injections
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinically definite multiple sclerosis (CDMS) according to Poser (Ann. Neurol. 1983) or McDonald (Ann. Neurol. 2001)
  2. Subjects eligible for GA treatment based on the investigator's clinical assessment and according to the current indication.
  3. Subjects must have a relapsing remitting disease course.
  4. Subjects must have had at least 1 documented relapse within the last year prior to study entry.
  5. Subjects may be male or female. Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or intrauterine device [IUD] with spermicide), or partner's vasectomy.
  6. Subjects must be between the ages of 18 and 55 years inclusive.
  7. Subjects must be ambulatory, with a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.0 inclusive.
  8. Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion Criteria:

  1. Long-term glatiramer acetate users who have been on therapy within 6 months of the baseline magnetic resonance imaging (MRI). New glatiramer acetate users who have initiated therapy for more than 6 weeks prior to the baseline MRI.
  2. Previous use of cladribine.
  3. Previous use of mitoxantrone.
  4. Use of digitalis at study entry.
  5. Previous use of immunosuppressive agents (such as azathioprine, cyclophosphamide or mycophenolate mofetil) in the last 6 months prior to screening.
  6. Use of experimental or investigational drugs, including intravenous (IV) immunoglobulin within 6 months prior to screening.
  7. Use of interferon agents within 1 month prior to the baseline MRI.
  8. Use of corticosteroids (IV, intramuscular [IM] and/or by mouth [PO]) within 30 days prior to the baseline MRI.
  9. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to the screening visit.
  10. Subjects with diabetes.
  11. Previous total body irradiation or total lymphoid irradiation.
  12. Pregnancy or breast feeding.
  13. Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse).
  14. Other diseases that can cause brain atrophy (ex. neurodegenerative disorder, cerebrovascular disease, history of alcohol abuse).
  15. Bone density less than -2.5 standard deviations (SD) (osteoporosis).
  16. A known history of sensitivity to mannitol.
  17. Contraindication to, or known history of, sensitivity or severe reaction to steroids.
  18. A known history of sensitivity to gadolinium.
  19. Inability to successfully undergo MRI scanning.
  20. Previous use of natalizumab.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203047

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Chair: Jean-Louis Stril, MD Teva Neuroscience Canada
  More Information

Additional Information:
No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00203047     History of Changes
Other Study ID Numbers: TNC GA MS 2004_01 (ASSERT)
Study First Received: September 13, 2005
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Multiple Sclerosis
brain atrophy
Glatiramer Acetate
Copaxone
Steroids
Prednisone

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
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012