A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months (GASWI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier:
NCT01695434
First received: September 26, 2012
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.


Condition Intervention
Multiple Sclerosis
Other: MRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective, Observational, Single-blinded, Longitudinal MRI Study of Effect of Glatiramer Acetate on Iron Deposition in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    MRI collected from RRMS patients who have taken Copaxone for 24 months


Secondary Outcome Measures:
  • To investigate whether treatment with GA may decrease accumulation of iron in lesions, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluate if Copaxone will decrease iron in lesions.


Enrollment: 60
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Copaxone MRI
Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI.
Other: MRI
All subjects will undergo a MRI.
Healthy Controls MRI
Subjects who are otherwise healthy, without neurological disorders, will have a MRI.
Other: MRI
All subjects will undergo a MRI.

Detailed Description:

This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients treated with GA and in healthy controls.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Copaxone as their disease modifying therapy.

Healthy controls from the general population.

Criteria

Inclusion Criteria:

  • MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
  • Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan
  • Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients)
  • Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy controls)
  • MS patients having a RR disease course (Lublin and Reingold, 1996)
  • Age 18-65 (healthy controls will be matched to MS patients for age and sex)
  • Signed informed consent at the 24-month follow-up
  • Pass MRI health screening
  • MS patients passing contrast screening
  • MS patients having normal kidney function (creatinine clearance >59)
  • None of the exclusion criteria

Exclusion Criteria:

  • Patients who had a relapse within 30 days prior to MRI baseline scan date
  • Patients who received steroid treatment within 30 days prior to the MRI baseline scan date
  • Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
  • MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
  • MS patients having abnormal kidney function (creatinine clearance <59)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695434

Locations
United States, New York
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
  More Information

No publications provided

Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01695434     History of Changes
Other Study ID Numbers: GA-SWI 24
Study First Received: September 26, 2012
Last Updated: March 21, 2013
Health Authority: United States: HSIRB

Keywords provided by University at Buffalo:
multiple sclerosis
MRI
Copaxone
healthy controls
glatiramer acetate

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 28, 2014