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Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

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ClinicalTrials.gov Identifier: NCT00202995
Recruitment Status : Terminated (Slow enrollment decreased sample size No unexpected safety issues.)
First Posted : September 20, 2005
Last Update Posted : October 18, 2010
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Glatiramer Acetate Drug: Betaseron Drug: Rebif Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients
Study Start Date : July 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Glatiramer Acetate 20 mg s.c. daily
Drug: Glatiramer Acetate
20 mg s.c. daily

Active Comparator: 2
Betaseron 250 ug every other day or Rebif 44 ug 3 times a week
Drug: Betaseron
250 mg every other day

Drug: Rebif
44 ug 3 times a week




Primary Outcome Measures :
  1. The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
  2. Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
  3. Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required.
  4. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
  5. Patients must be between the ages of 18 and 50 years inclusive
  6. 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 IUD with spermicide), or partner's vasectomy
  7. Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
  8. Patients must be relapse-free and off corticosteroids between the screening and baseline visits
  9. Patients must be willing and able to give written informed consent

Exclusion Criteria:

  1. Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
  2. Previous treatment with glatiramer acetate (injectable)
  3. Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years
  4. Previous total body irradiation or total lymphoid irradiation
  5. Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
  6. Pregnancy or breastfeeding
  7. Life-threatening or other clinically significant disease
  8. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
  9. A known sensitivity to gadolinium (gadolinium acid)
  10. A known history of sensitivity to mannitol
  11. Inability to successfully undergo MRI scanning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202995


Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
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Study Director: Helene Brooks Teva Neuroscience, Inc.

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Responsible Party: Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00202995     History of Changes
Other Study ID Numbers: 9013
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 18, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
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Glatiramer Acetate
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Interferon beta-1b
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Antirheumatic Agents