Trial Outcomes & Findings for Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA) (NCT NCT00937157)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Change from baseline at 180 days and change from baseline at 360 days

Results posted on

2021-03-19

Participant Flow

Recruitment from the pool of relapsing-remitting multiple sclerosis patients (RRMS) at the Jacob's Neurological Institute (JNI) was open for approximately one year.

All enrolled patients had to meet all inclusion criteria and no exclusion criteria. Patients were to be 18-65 years of age, have a disease duration of 3months to 20 years, be diagnosed with RRMS according to McDonald criteria, one enhancing lesion 30 days prior to screening and an EDSS score equal to or below 5.5.

Participant milestones

Participant milestones
Measure	RRMS Patients With >=1 GdE Lesion or Acute Relapse Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse. Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	RRMS Patients With >=1 GdE Lesion or Acute Relapse Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse. Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
Overall Study Pregnancy	1
Overall Study Lost to Follow-up	3

Baseline Characteristics

Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Diagnosed With Multiple Sclerosis Who Have the Presen n=12 Participants Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	43 years STANDARD_DEVIATION 7.823 • n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment United States	12 participants n=99 Participants

PRIMARY outcome

Timeframe: Change from baseline at 180 days and change from baseline at 360 days

Population: Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.

Outcome measures

Outcome measures
Measure	Patients Diagnosed With Multiple Sclerosis Who Have the Presen n=16 GAD lesions Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. GAD lesions from 0-180	-3.7 GAD lesions (number of) Standard Deviation 5.8
A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. GAD lesion from 0-360	-3.6 GAD lesions (number of) Standard Deviation 4.2

Adverse Events

RRMS Patients With >=1 GdE Lesion or Acute Relapse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Zivadinov, MD, PhD

Buffalo Neuroimaging Analysis Center

Phone: 716-859-7040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place