Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate

NCT00203047 | Terminated Phase 4 Results DMC

• 1 other identifier: TNC GA MS 2004_01
• Study Type: interventional
• Target: 414
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; brain atrophy; Glatiramer Acetate; Copaxone; Steroids; Prednisone

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method

  Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change. Adjusted (least square) mean values are presented.

  Day 0, latest scan at month 24, 36 or early termination visit

Secondary Outcomes (3)

• Cumulative Number of Enhancing Lesions at Months 12, 24 and 36

  Months 12, 24, and 36

• Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions

  Day 0, Month 36 or the early termination visit

• Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions

  Day 0, Month 36 or early termination visit

Study Arms (2)

GA + Placebo

ACTIVE COMPARATOR

Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.

Drug: Glatiramer Acetate; Drug: Placebo

GA + Prednisone

EXPERIMENTAL

Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.

Drug: Glatiramer Acetate; Drug: Prednisone

Interventions

Glatiramer Acetate DRUG

20mg glatiramer acetate (GA) administered by daily subcutaneous injections

Also known as: Copaxone

GA + Placebo; GA + Prednisone

Placebo DRUG

Placebo for prednisone given daily

GA + Placebo

Prednisone DRUG

Prednisone 1250 mg taken daily

Also known as: corticosteroid

GA + Prednisone

Eligibility Criteria

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

You may qualify if:

• Clinically definite multiple sclerosis (CDMS) according to Poser (Ann. Neurol. 1983) or McDonald (Ann. Neurol. 2001)
• Subjects eligible for GA treatment based on the investigator's clinical assessment and according to the current indication.
• Subjects must have a relapsing remitting disease course.
• Subjects must have had at least 1 documented relapse within the last year prior to study entry.
• Subjects may be male or female. 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 intrauterine device \[IUD\] with spermicide), or partner's vasectomy.
• Subjects must be between the ages of 18 and 55 years inclusive.
• Subjects must be ambulatory, with a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.0 inclusive.
• Subjects must be willing and able to give written informed consent prior to entering the study.

You may not qualify if:

• Long-term glatiramer acetate users who have been on therapy within 6 months of the baseline magnetic resonance imaging (MRI). New glatiramer acetate users who have initiated therapy for more than 6 weeks prior to the baseline MRI.
• Previous use of cladribine.
• Previous use of mitoxantrone.
• Use of digitalis at study entry.
• Previous use of immunosuppressive agents (such as azathioprine, cyclophosphamide or mycophenolate mofetil) in the last 6 months prior to screening.
• Use of experimental or investigational drugs, including intravenous (IV) immunoglobulin within 6 months prior to screening.
• Use of interferon agents within 1 month prior to the baseline MRI.
• Use of corticosteroids (IV, intramuscular \[IM\] and/or by mouth \[PO\]) within 30 days prior to the baseline MRI.
• Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to the screening visit.
• Subjects with diabetes.
• Previous total body irradiation or total lymphoid irradiation.
• Pregnancy or breast feeding.
• Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse).
• Other diseases that can cause brain atrophy (ex. neurodegenerative disorder, cerebrovascular disease, history of alcohol abuse).
• Bone density less than -2.5 standard deviations (SD) (osteoporosis).

Sponsors & Collaborators

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

Related Publications (1)

• Milo R, Panitch H. Combination therapy in multiple sclerosis. J Neuroimmunol. 2011 Feb;231(1-2):23-31. doi: 10.1016/j.jneuroim.2010.10.021. Epub 2010 Dec 15.

  PMID: 21111490 RESULT

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Glatiramer Acetate; Prednisone; Adrenal Cortex Hormones

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)

Peptides; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Jean-Louis Stril, MD

  Teva Neuroscience Canada

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 6, 2014
• Results First Posted: January 6, 2014

Record last verified: 2013-11