Table 3, Characteristics of the Included Primary Clinical Studies - Glatiramer Acetate and Interferon Beta 1a and 1b for Clinically Isolated Syndrome: A Review of Clinical Effectiveness and Guidelines

First Author, Publication Year, Country	Study Design	Population Characteristics	Intervention and Comparator(s)	Clinical Outcomes, Length of Follow-Up
De Stefano et al., 2014¹⁹ Italy The study was funded by a manufacturer	The REFLEX RCT^a	517 patients aged 18 to 50 years with an EDSS score of 0 to 5, with a history of a single demyelinating event suggestive of MS within 60 days prior to study entry and ≥2 clinically silent lesions on a T2-weighted brain MRI scan ≥3 mm, ≥ 1 ovoid, periventricular or infratentorial; time of enrollment NR Median age: 29 years (range, 24 to 37) % female: 64.2% Exclusion criteria: NR	Intervention: IFN β-1a 44 mcg SC thrice weekly (n = 171), IFN β-1a 44 mcg SC once a week (n = 175) Comparator: placebo (n = 171)	Mean number of lesions per patient per scan, change in lesion volume from baseline Follow-up: 24 months or conversion to CDMS, whichever occurred first Change in brain volume from baseline was not included in this review

First Author, Publication Year, Country

Study Design

Population Characteristics

Intervention and Comparator(s)

Clinical Outcomes, Length of Follow-Up

De Stefano et al., 2014¹⁹

Italy

The study was funded by a manufacturer

The REFLEX RCT^a

517 patients aged 18 to 50 years with an EDSS score of 0 to 5, with a history of a single demyelinating event suggestive of MS within 60 days prior to study entry and ≥2 clinically silent lesions on a T2-weighted brain MRI scan ≥3 mm, ≥ 1 ovoid, periventricular or infratentorial; time of enrollment NR

Median age: 29 years (range, 24 to 37)

% female: 64.2%

Exclusion criteria: NR

Intervention: IFN β-1a 44 mcg SC thrice weekly (n = 171), IFN β-1a 44 mcg SC once a week (n = 175)

Comparator: placebo (n = 171)

Mean number of lesions per patient per scan, change in lesion volume from baseline

Follow-up: 24 months or conversion to CDMS, whichever occurred first

Change in brain volume from baseline was not included in this review

From: Glatiramer Acetate and Interferon Beta 1a and 1b for Clinically Isolated Syndrome: A Review of Clinical Effectiveness and Guidelines

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Glatiramer Acetate and Interferon Beta 1a and 1b for Clinically Isolated Syndrome: A Review of Clinical Effectiveness and Guidelines [Internet].

Williams D, Butcher R.

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Sep 18.

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Table 3Characteristics of the Included Primary Clinical Studies