CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 75 enrolled
Drug / intervention
Betaseron +1 moredrug
Likely dose
Betaseron 250 micrograms injected subcutaneously every other day or Copaxone 20 mg injected subcutaneously every dayAI-extracted
Key inclusion· 5
  • ✓Age 18-55 years at baseline
  • ✓Relapsing-remitting MS with one or more clinical and/or MRI lesions in the 6 months prior to entry
  • ✓CIS consistent with CNS demyelination with onset within 6 months, with dissemination in space (≥2 brain MRI lesions ≥3 mm, at least one ovoid or periventricular) and dissemination in time (non-enhancing lesions if acute ≤1 month, or enhancing lesions if >1 month)
  • ✓EDSS score 0-5.5 at baseline
Key exclusion· 11
  • ✕Relapse onset between screening and Study Day 1
  • ✕Conditions affecting the CNS or interfering with MRI results or other study evaluations
  • ✕Metallic devices or foreign bodies that are MRI contraindications
  • ✕Body size unable to fit in 3T MRI scanner

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00176592
NCT00176592Phase 4Completed
CompareCT.gov

Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose Gadolinium

University of Medicine and Dentistry of New Jersey·interventional·Posted Sep 15, 2005·Updated Nov 16, 2021

In Brief

A Phase 4 clinical trial evaluating Betaseron and Copaxone for Multiple Sclerosis. Completed, enrolled 75 participants across 1 site.

Detailed Summary

This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing forms of MS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJan 1, 2003
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.8 years ago

Interventions

Betaserondrug

Betaseron 250 micrograms injected SQ every other day

Copaxonedrug

Copaxone 20 mg injected SQ every day (glatiramer acetate)