CClinicalTrials.gg
TerminatedNCT00202995Updated Oct 18, 2010

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

A Phase 4 interventional study of Glatiramer Acetate and Betaseron in Relapsing Remitting Multiple Sclerosis, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Terminated. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-10-18.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 4, Interventional, and Prevention

Why this study was terminated
Slow enrollment decreased sample size No unexpected safety issues.
Phase
Phase 4
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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®

02

Conditions studied

  • Relapsing Remitting Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 91 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    1

    Glatiramer Acetate 20 mg s.c. daily

    Drug: Glatiramer Acetate

  • Active comparator
    2

    Betaseron 250 ug every other day or Rebif 44 ug 3 times a week

    Drug: Betaseron · Drug: Rebif

Interventions

  • DrugGlatiramer Acetate

    20 mg s.c. daily

  • DrugBetaseron

    250 mg every other day

  • DrugRebif

    44 ug 3 times a week

06

What researchers measure

Primary outcomes

  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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00202995
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
First posted
Sep 20, 2005
Start date
Jul 2004
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Oct 18, 2010

Study contacts

Helene Brooks
study director · Teva Neuroscience, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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