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

NCT00202995 | Terminated Phase 4 DMC

• 1 other identifier: 9013
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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®

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

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.

Study Arms (2)

1

EXPERIMENTAL

Glatiramer Acetate 20 mg s.c. daily

Drug: Glatiramer Acetate

2

ACTIVE COMPARATOR

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

Drug: Betaseron; Drug: Rebif

Interventions

Glatiramer Acetate DRUG

20 mg s.c. daily

1

Betaseron DRUG

250 mg every other day

2

Rebif DRUG

44 ug 3 times a week

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
• Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
• 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.
• Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
• Patients must be between the ages of 18 and 50 years inclusive
• 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
• Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
• Patients must be relapse-free and off corticosteroids between the screening and baseline visits
• Patients must be willing and able to give written informed consent

You may not qualify if:

• Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
• Previous treatment with glatiramer acetate (injectable)
• 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
• Previous total body irradiation or total lymphoid irradiation
• Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
• Pregnancy or breastfeeding
• Life-threatening or other clinically significant disease
• Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
• A known sensitivity to gadolinium (gadolinium acid)
• A known history of sensitivity to mannitol
• Inability to successfully undergo MRI scanning

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate; Interferon beta-1b; Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• Helene Brooks

  Teva Neuroscience, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 18, 2010

Record last verified: 2010-10