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. 2013 Apr;3(2):65–80. doi: 10.1177/1941874412457183

Table 2.

Clinical Trials Testing DMT in High-Risk CIS Patients.

Abbreviated Study Name Study design and Duration N Inclusion Criteria Treatments Primary End Points Percentage With CDMS At Study End Time to CDMS (Days for 25th-30th percentile) MRI Changes
CHAMPS71 Randomized, double blind 3 years (terminated early due to efficacy in preplanned interim analysis) 383 CIS onset within 4 weeks, ≥2 silent MRI brain lesions (≥3 mm diameter, with ≥1 lesion either periventricular or ovoid) IM IFNβ-1a (Avonex) 30 μg q week versus placeboa Time to CDMS 35% on IFNβ-1a 50% on placebo (P = .002) 809 on IFNβ-1a 397 on placebo Gd-enhancing lesions, new or enlarging T2 lesions, increase in lesion volume significantly lower with IFNβ-1a
ETOMS67 Randomized, double blind 2 years 309 CIS onset within 3 months, ≥4 silent MRI brain lesions (≥3 lesions if there is an infratentorial or Gd-enhancing lesion) SC IFNβ-1a (Rebif) 22 μg q weekb versus placebo Time to CDMS 34% on IFNβ-1a 45% on placebo (p = 0.047) 569 on IFNβ-1a 252 on placebo New T2 lesions and increase in lesion load significantly lower with IFNβ-1a
BENEFIT40, 76 Randomized, double blind 2 years 468 CIS onset within 60 days, ≥2 silent MRI brain lesions (≥3 mm in diameter, with ≥1 lesion ovoid, periventricular, or infratentorial) SC IFNβ-1b (Betaseron) 250 μg qod versus placebo Time to CDMS 28% on IFNβ-1b 45% on placebo (P < .0001) 618 on IFNβ-1b 255 on placebo New T2 lesions, Gd-enhancing lesions, volume of Gd-enhancing lesions significantly lower with IFNβ-1b
PreCISe77 Randomized, double blind 2.3 years (mean) 481 CIS onset within 90 days, ≥2 silent MRI brain lesions ≥6 mm in diameter SC GA (Copaxone) 20 mg daily versus placebo Time to CDMS 25% on GA 43% on placebo (P = .0005) 722 on GA 336 on placebo New T2 lesions and volume, Gd-enhancing lesions, T1 hypointense lesions signficantly lower with GA

Abbreviations: CDMS, clinically definite multiple sclerosis; CIS, clinically isolated syndrome; DMT, disease-modifying therapy; FDA, Food and Drug Administration; GA, glatiramer acetate; Gd, gadolinium; IFN, interferon; IM, intramuscular; MRI, magnetic resonance imaging; q, every; SC, subcutaneous.

a All patients treated with high-dose methylprednisone and an 11-day prednisone taper prior to initiating study drug.

b Lower quantity and less frequent than the current FDA-approved dose.

Modified from Connor and Smith.104 Reproduced with permission from Consensus Medical Communications.