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Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate
This study is ongoing, but not recruiting participants.
First Received: September 13, 2005   Last Updated: March 23, 2009   History of Changes
Sponsored by: Teva Pharmaceutical Industries
Information provided by: 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

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Copolymer 1
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

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
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Glatiramer Acetate
    20mg GA administered by daily subcutaneous injections
Detailed Description:

Study evaluating the effect of pulse oral steroids administered every 4 months, for a period of three years, as an add-on treatment to GA, given every day, in patients with relapsing remitting multiple sclerosis.

  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

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78229
Canada, Quebec
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada, G7H 5T6
Centre Hospitalier Régional de Trois-Rivières, Pavillon St-Joseph
Trois-Rivières, Quebec, Canada, G9A 1Y1
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Chair: Carole Desforges Teva Neuroscience Canada
  More Information

Additional Information:
No publications provided

Responsible Party: Teva Neuroscience ( J. Michael Nicholas, Ph.D., Sr. Director, US Regulatory Affairs )
Study ID Numbers: TNC GA MS 2004_01 (ASSERT)
Study First Received: September 13, 2005
Last Updated: March 23, 2009
ClinicalTrials.gov Identifier: NCT00203047     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada;   Australia:

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

Study placed in the following topic categories:
Prednisone
Autoimmune Diseases
Demyelinating Diseases
Immunologic Factors
Adjuvants, Immunologic
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Immunosuppressive Agents
Copolymer 1
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Atrophy
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Immunosuppressive Agents
Pharmacologic Actions
Copolymer 1
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009