Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week in Subjects With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

An Open-label, Prospective, Observational, Single-blinded, Longitudinal, Cross-over Study to Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week on Thalamic Pathology in Subjects With Relapsing-remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308670
• Other study ID #: GA20-40
• Status: Completed
• Phase: N/A
• First received: July 23, 2014
• Last updated: October 24, 2016
• Start date: July 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The primary aim of this study is to observe any changes in MRI in MS patients who have switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.

Description:

The primary aim of this study is to observe the effect of switching from daily injections of 20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on thalamus pathology, as measured by changes in diffusion-tensor imaging (DTI) in patients with relapsing-remitting multiple sclerosis (RRMS). We hypothesize that GA 40mg x 3/weekly will exert similar, if not better effect on prevention of thalamic pathology, as compared to GA 20mg/daily. The secondary objective of this study is to investigate the effect of switching from GA 20mg/daily to GA 40mg x 3/weekly on evolution of microstructural changes in normal appearing white matter (NAWM) and normal appearing gray matter (NAGM), as measured by DTI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• MS patients diagnosed with MS according to the McDonald criteria

• MS patients having a relapsing disease course

• Being on GA monotherapy (20mg/daily sc) for at least 12 months prior to the standard of care MRI at the time of switch to GA 40mg x 3/weekly

• Having standard of care 3T MRI scan while on GA 20mg/daily treatment for at least 12-18 months prior to the start day of the of the GA 40mg x 3/weekly and at the time of switch to GA 40mg x 3/weekly Age over 18

• Pass MRI health screening (in case of EGFR <59, the contrast will not be applied)

• None of the exclusion criteria

Exclusion Criteria:

• Patients who had a relapse within 30 days prior to MRI scan date

• Patients who received steroid treatment within 30 days prior to the MRI 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 12 months prior to start of GA 40mg 3/weekly (e.g., IFN-ß, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
United States	Buffalo Neuroimaging Analysis Center	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	TEVA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute and percent change in thalamus pathology as measured by axial and radial diffusivity using diffusion tensor imaging tract-based spatial statistics	The primary endpoint is to explore the effect of GA 40mg x 3/weekly on thalamus pathology, as measured by changes in RD and AD on DTI TBSS in patients with RRMS, as compared to GA 20mg/daily.	1 year after enrollment	No
Secondary	Absolute and percent changes in normal-appearing white and grey matter as measured by fractional anisotropy and mean diffusivity using diffusion tensor imaging tract-based spatial statistics.	The secondary endpoint is to investigate the effect of GA 40mg x 3/weekly on evolution of microstructural changes in NAWM and NAGM, as measured by FA and MD on DTI global and the TBSS (only NAWM) approaches, as compared to GA 20mg/daily.	1 year after enrollment	No