Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI

NCT00176592 | Completed Phase 4 Results DMC

• 1 other identifier: 0120020167
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Brain; Betaseron; Copaxone; MRI

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure is the Number of "Combined Active Lesions" (CAL) by Monthly MRI at the Conclusion of the Study.

  Results are per patient mean number of lesions per scan. Results are per patient mean number of lesions per elapsed month. Contrasts types are: IFN 1b interferon beta 1b and GA glatiramer acetate.

  up to 2 years

Secondary Outcomes (2)

• The Number of Enhancing Lesions.

  up to 2 years

• The Number of MRI Disease Free Patients.

  1 year

Study Arms (2)

Betaseron

ACTIVE COMPARATOR

Betaseron 250 micrograms SQ every other day and Triple-Dose Gadolinium at each MRI

Drug: Betaseron

Copaxone

ACTIVE COMPARATOR

Copaxone 20 mg daily SQ and Triple-Dose Gadolinium at each MRI

Drug: Copaxone

Interventions

Betaseron DRUG

Betaseron 250 micrograms injected SQ every other day

Also known as: Betaseron 250 mcg SQ every other day, Intaferon beta 1 b

Betaseron

Copaxone DRUG

Copaxone 20 mg injected SQ every day (glatiramer acetate)

Also known as: Copaxone 20 mg injected SQ every day (glatiramer acetate)

Copaxone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must meet all of the following criteria at the time of the baseline visit in order to enter the trial:
• Be Between 18 and 55 years of age, at baseline.
• Be capable of informed consent in English prior to any study related procedures.Spanish speaking patients who do not read English well can give written informed consent if a relative or friend fluent in both English and Spanish has translated the consent and any questions the patient may have.
• Be available and willing to complete all study assessments.
• Presently meet one of the two following forms of multiple sclerosis:
• Relapsing-remitting ms plus evidence of recent disease activity as shown by the development of one or more clinical and/or MRI lesions during the 6 months prior to entry into the study.
• A CIS consistent with central nervous system (CNS) demyelination confirmed on ophthalmologic or neurological examination with onset within 6 months prior to study entry. Also:a- evidence of dissemination in space, there should be two or more brain MRI lesions ≥ 3 mm in size at least one of which should be ovoid and/or periventricular in location; and b- As evidence of dissemination in time, if the CIS is acute (≤1 month) there should be one or more non-enhancing lesion or if the CIS is not acute (older than 1 month) the MRI should show one or more enhancing lesions.
• At baseline, have an EDSS between 0-5.5.
• Females of childbearing potential must agree to practice adequate contraception methods. All females must have negative pregnancy test results at screening and a negative urine pregnancy test at baseline.
• Screening laboratory results that confirm adequate bone marrow, renal, and hepatic function.

You may not qualify if:

• Patients were not permitted into the study if they met any of the following criteria:
• Onset of a relapse between screening and Study Day 1.
• Present evidence or history of any conditions that could affect the CNS or interfere with the MRI results or any other evaluation in the study.
• Possess any of the standard metallic devices or foreign bodies that are contraindications for MRI.
• Patient weight and or size unable to fit in the 3T MRI scanner.
• Pregnancy, as denoted by a positive serum pregnancy test at screening visit or a positive urine pregnancy test at the baseline visit. Subjects who are breast-feeding are also excluded.
• Have a known allergy or hypersensitivity to Gadolinium-chelates, human proteins including albumin and interferons, or Glatiramer Acetate or Mannitol.
• Uncontrolled, clinically significant heart diseases, such as dysrhythmias, angina, or uncompensated congestive heart failure. History of or current unstable medical conditions that could be deemed clinically significant.
• Intolerance or any contraindication to acetaminophen, ibuprofen, or steroids.
• Inability, in the opinion of the principal investigator or staff, to be compliant with protocol requirements for the duration of the study.
• Participation in any clinical trial within the past six months
• History or present evidence of addictions.
• Have active peptic ulcer disease.
• Inability to have subcutaneous injections administered.
• Medical, psychiatric or other conditions that compromise the patient's ability to understand the study procedures.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Related Publications (3)

• Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K, Kamin SS, Pachner AR, Halper J, Cook SD. Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study. Neurology. 2009 Jun 9;72(23):1976-83. doi: 10.1212/01.wnl.0000345970.73354.17. Epub 2009 Mar 11.

  PMID: 19279320 RESULT

• Cadavid D, Cheriyan J, Skurnick J, Lincoln JA, Wolansky LJ, Cook SD. New acute and chronic black holes in patients with multiple sclerosis randomised to interferon beta-1b or glatiramer acetate. J Neurol Neurosurg Psychiatry. 2009 Dec;80(12):1337-43. doi: 10.1136/jnnp.2008.171090. Epub 2009 Aug 16.

  PMID: 19687024 RESULT

• Maranzano J, Rudko DA, Nakamura K, Cook S, Cadavid D, Wolansky L, Arnold DL, Narayanan S. MRI evidence of acute inflammation in leukocortical lesions of patients with early multiple sclerosis. Neurology. 2017 Aug 15;89(7):714-721. doi: 10.1212/WNL.0000000000004227. Epub 2017 Jul 19.

  PMID: 28724581 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b; Glatiramer Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Stuart Cook, MD
• Organization: Rutgers New Jersey Medical School

cooksd@njms.rutgers.edu

973-972-2550

Study Officials

• Stuart D Cook, MD

  MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Neurology, NJMS & RWJMS

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2003
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)