Study ID MS type (diagnostic criteria) | Study details | Characteristics of participants at baseline | Intervention | Participants |
---|---|---|---|---|
ADVANCE 2014 RRMS (2005 McDonald criteria) | Country: USA, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Estonia, France, Georgia, Germany, Greece, India, Latvia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom. No. of countries: 26 Centres: 183 Study period: June 2009 and November 2011. Sponsor: Biogen Idec | Mean age: 36.5 (9.9) Mean sex: 71% female Race: 82% white EDSS Score: 2.5 Relapse rate: 1.6 within the previous 12 months, 2.6 within the previous 36 months Time from diagnosis of MS: 3.6 years Other clinical features of MS: Time from first MS symptoms: 6.6 years | Arm 1: pegylated IFN β-1a 125 μg SC every 2 weeks (Plegridy) Arm 2: Placebo | Randomised 512 arm 1 500 arm 2 |
AVANTAGE 2014 RRMS/CIS, diagnostic criteria unclear | Country: France No. of countries: 1 Centres: 61 Study period: March 2006–April 2008, 3 months follow up Sponsor: Bayer | Mean age: 38.7 Mean sex: 75% female Race: NA EDSS Score: 1.8 ± 1.3 Mean number of relapse rate: 2.1 ± 1.1 Time from diagnosis of MS: 3.3 (6.4) years Other clinical features of MS: NA | Arm 1: IFN β-1b 250 μg SC every other day (Betaferon) via Betaject Arm 2: IFN β-1b 250 μg SC every other day (Betaferon) via Betaject light Arm 3: IFN β-1a 44 SC three times weekly (Rebif) via Rebiject II | Included: 73 arm 1 79 arm 2 68 arm 3 |
BECOME 2009 RRMS/CIS (likely McDonald 2001 or 2005) | Country: USA No. of countries: 1 Centres: 2 Study period: Not specified, follow up over 2 years Sponsor: Bayer Schering pharma | Mean age: 36 Mean sex: 69% females Race: 52% white Median EDSS Score: 2 Relapse rate: 1.8 and 1.9 ARR Time from diagnosis of MS: between 0.9 and 1.2 Other clinical features of MS: 81% RRMS, 19% CIS; MSFC median 0.13 | Arm 1: IFN β-1b 250 μg SC every other day (Betaferon) Arm 2: GA 20 mg SC daily (Copaxone) | Randomised 36 arm 1 39 arm 2 |
BEYOND 2009 RRMS (McDonald 2005) | Country: Not specified No. of countries: 26 Centres: 198 Study period: November, 2003, and June, 2005. Follow up between 2 and 3.5 years Sponsor: Bayer | Mean age 35.6 Mean sex: 69.4% female Race: 91.9% white EDSS Score: 2.33 Relapse rate: 1.6 relapses in last year Time from diagnosis of MS: 5.2 years Other clinical features of MS: 3.6 relapses previously; 70.6% had two or more relapses in past 2 years | Arm 1: IFN β-1b 250 μg SC every other day (Betaferon) Arm 2: GA 20 mg SC daily (Copaxone) | Randomised 897 arm 1 448 arm 2 |
Bornstein 1987 RRMS (Poser) | Country: USA No. of countries: 1 Centres: Not specified Study period: Not specified, follow up over 2 years Sponsor: public (grant from the National Institute of Neurological and Communicative Disorders and Stroke and grant from the National Institutes of Health) | Mean age: 30.5 Mean sex: 42% male/58% female Race: 96% white EDSS Score: 3.11 Relapse rate: 3.85 over 2 years Time from diagnosis of MS: 5.5 years duration of disease Other clinical features of MS: NA | Arm 1: GA 20 mg SC daily (Copaxone) Arm 2: Placebo | Randomised 25 arm 1 25 arm 2 |
BRAVO 2014 RRMS (McDonald 2005) | Country: US, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Germany, Israel, Italy, Lithuania, Macedonia, Poland, Romania, Russia, Slovakia, South Africa, Spain, Ukraine and others not specified No. of countries: 18 Centres: 140 Study period: April 2008 to June 2011. 24 months follow up Sponsor: Teva Pharmaceutical Industries | Mean age: Median: 37.5 placebo, 38.5 IFN Mean sex: 71.3% females in placebo arm, 68.7% females in IFN arm Race: N/A EDSS Score: Median: 2.5 placebo, 2.5 IFN Median Relapse rate: previous year: 1.0 placebo, 1.0 IFN; previous 2 years: 2.0 placebo, 2.0 IFN Median Time from diagnosis of MS: 1.2 placebo, 1.4 IFN Other clinical features of MS: NA | Arm 1: IFN β-1a 30 μg IM once weekly (Avonex) Arm 2: Oral placebo once-daily with neurologist monitoring | Randomised 447 arm 1 450 arm 2 |
Calabrese 2012 RRMS (McDonald 2005) | Country: Italy No. of countries: 1 Centres: 1 Study period: 1 Jan 2007–30 June 2008 Follow up over 2 years Sponsor: grant from Merck Serono S.A | Mean age: 36.5 (9.9) Mean sex: 70.2% of female/20.8% of male Race: NA EDSS Score: 2.1 (1.1) Relapse rate: 1.2 (0.7) Time from diagnosis of MS: 5.6 years (2.4) Other clinical features of MS: None | Arm 1: IFN β-1a 44 SC three times weekly (Rebif) Arm 2: IFN β-1a 30 μg IM once weekly (Avonex) Arm 3: GA 20 mg SC daily (Copaxone) | Randomised 55 arm 1 55 arm 2 55 arm 3 |
CombiRx 2013 RRMS (McDonald 2001, Poser) | Country: United States, Canada No. of countries: 2 Centres: 68 Study period: January 2005–April 2012. Minimally 36 months follow up Sponsor: NIH, with materials provided by Biogen and Teva | Mean age 38.3 Mean sex: 70.3% female Race: 87.6% white EDSS Score: 2.0 Relapse rate: 1.7 relapses in last year, on average Time from diagnosis of MS: 1.2 Other clinical features of MS: NA | Arm 1: IFN β-1a 30 μg IM once weekly (Avonex) Arm 2: GA 20 mg SC daily (Copaxone) | Randomised 250 arm 1 259 arm 2 |
CONFIRM 2012 RRMS (McDonald 2005) | Country: USA, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, India, Ireland, Israel, Latvia, Macedonia, Mexico, Republic of Moldova, New Zealand, Poland, Puerto Rico, Romania, Serbia, Slovakia, Spain, Ukraine No. of countries: 28 Centres: 200 Study period: 2 year follow up Sponsor: Biogen idec | Mean age 36.8 Mean sex: 70% female Race: 84% white EDSS Score: 2.6 Relapse rate: 1.4 in prior 12 months Time from diagnosis of MS: 4.6 years Other clinical features of MS: any prior DMTs (%) = 29% | Arm 1: GA 20 mg SC daily (Copaxone) Arm 2: 2 placebo capsules orally thrice daily | Randomised 360 arm 1 363 arm 2 |
Cop1 MSSG 1995 RRMS (Poser) | Country: USA No. of countries: 1 Centres: 11 Study period: October, 1991, and May, 1992. 2 year follow up. Sponsor: the FDA orphan drug program, the National multiple sclerosis society, and TEVA pharmaceutical | Mean age 34.4. Mean sex: 73% female Race: 94% white EDSS Score: 2.6 Relapse rate: 2.9 prior 2-year rate MS duration:6.9 years Other clinical features of MS: ambulation index = 1.1 | Arm 1: GA 20 mg SC daily (Copaxone) Arm 2: Placebo | Randomised 125 arm 1 126 arm 2 |
ECGASG 2001 RRMS (Poser) | Country: Canada No. of countries: 7 Centres: 29 Study period: Enrollment started in February 1997 and concluded in November 1997. 9 month follow up Sponsor: Teva Pharmaceutical Industries | Mean age 34 Mean sex: NA Race: NA EDSS Score: 2.4 Relapse rate: 2.65 Disease duration (years): 8.1 Other clinical features of MS: ambulation index = 1.15 | Arm 1: GA 20 mg SC daily (Copaxone) Arm 2: Placebo SC injections | Randomised 119 arm 1 120 arm 2 |
Etemadifar 2006 RRMS (Poser) | Country: Iran No. of countries: 1 Centres: 1 Study period: September 2002 and September 2004. 24 month follow up Sponsor: Not specified | Mean age 28.5 Mean sex: 76% female Race: NA EDSS Score: 2.0 Relapse rate 1 year prior: 2.2 Time from diagnosis of MS: 3.2 years Other clinical features of MS: None | Arm 1: IFN β-1b 250 μg SC every other day (Betaferon) Arm 2: IFN β-1a 30 μg IM once weekly (Avonex) Arm 3: IFN β-1a 44 SC three times weekly (Rebif) | Randomised 30 arm 1 30 arm 2 30 arm 3 |
EVIDENCE 2007 RRMS (Poser) | Country: USA, France, UK, Norway, Austria, Germany, France, Finland, Sweden, Canada No. of countries: 10 Centres: 56 Study period: Unclear. Minimally 48 weeks follow up, average 64.2 Sponsor: Serono | Mean age 37.9 Mean sex: 74.8% female Race: 91.0% Caucasian EDSS Score: 2.3 Median: 2.0 Relapse rate: 2.6 Median 2.0 relapses in last 2 years Duration of MS: 6.6. Median: 4.0–4.1 years Other clinical features of MS: Time since last relapse (months): Median 3.9 to 4.4; mean 5.1 | Arm 1: IFN β-1a 44 SC three times weekly (Rebif) Arm 2: IFN β-1a 30 μg IM once weekly (Avonex) | Randomised 339 arm 1 338 arm 2 |
GALA 2013 RRMS (McDonald 2005) | Country: United States, Bulgaria, Croatia, Germany, Poland, Romania, and Ukraine and others No. of countries: 17 Centres: 142 Study period: Not specified. 12 months follow up. Sponsor: TEVA pharmaceutical industries | Mean age 37.6 Mean sex: 68% female Race: 98% Caucasian EDSS Score: 2.7 Relapse rate: 1.3 in the prior 12 months, 1.9 in the prior 24 months Time from diagnosis of MS: NA Other clinical features of MS: Time from onset of first symptoms of MS = 7.7 years | Arm 1: GA 40 mg SC three times weekly (Copaxone) Arm 2: SC placebo injections | Randomised 943 arm 1 461 arm 2 |
GATE 2015 RRMS (McDonald 2010) | Country: USA, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Germany, Italy, Mexico, Republic of Moldova, Poland, Romania, Russian Federation, Serbia, South Africa, Ukraine, United Kingdom No. of countries: 20 Centres: 118 Study period: Recruited between December 7, 2011, and March 21, 2013; last follow-up December 2, 2013. Follow up 9 months (double-blind follow-up) + additional 15 months (open-label) Sponsor: Synthon BV | Mean age 33.1 Mean sex: 66.4% female Race: NA EDSS Score: 2.7 Relapse rate: 1.9 in prior 2 years Time from diagnosis of MS: NA Other clinical features of MS: • Time to onset of first symptoms to randomisation (years): 5.9 • No history of prior disease treatment: 16.1% | Arm 1: GA 20 mg SC daily (Copaxone) Arm 2: Placebo | Randomised 357 arm 1 84 arm 2 |
IFNB MSSG 1995 RRMS (Poser) | Country: USA and Canada No. of countries: 2 Centres: 11 Study period: after 2 years of follow-up, all subjects were given the option of continuing treatment in a double-blind fashion, extending the total treatment period to 5.5 years for some patients Sponsor: Triton Biosciences, Berlex Laboratories | Mean age 35.6 Mean sex: 70% female Race: 94% white EDSS Score: 2.9 Relapse rate: 3.5 in prior 2 years Time from diagnosis of MS:4.3 years Other clinical features of MS: Baseline Scripps neurological rating scale: 80.8 | Arm 1: IFN β-1b 250 μg SC every other day (Betaferon) Arm 2: SC injections placebo | Randomised 124 arm 1 123 arm 2 |
IMPROVE 2012 RRMS (McDonald 2005) | Country: Italy, Germany, Serbia, Canada, Bulgaria, Estonia, Lithuania, Romania, Russia, Spain No. of countries: 10 Centres: 5 Study period: December 2006 to February 2009. Follow up 16 weeks for the double-blind phase, then 24 weeks where all patients received interferon beta 1-a, at last 4 weeks of safety period observation Sponsor: Merck Serono S.A. | Mean age NA Mean sex: NA Race: NA EDSS Score: NA Relapse rate: NA Time from diagnosis of MS: NA Other clinical features of MS: NA | Arm 1: IFN β-1a 44 SC three times weekly (Rebif) Arm 2: SC injections of placebo | Randomised 120 arm 1 60 arm 2 |
INCOMIN 2002 RRMS (Poser) | Country: Italy No. of countries: 1 Centres: 15 Study period: October, 1997, and June, 1999. 2 year follow up Sponsor: Istituto Superiore di Sanita’ of the Italian Ministry of Health and the Italian MS Society | Mean age 36.9 Mean sex: 65% female Race: NA EDSS Score: 1.97 Relapse rate 2 years prior: 1.45 Time from diagnosis of MS: 6.3 years Other clinical features of MS: None | Arm 1: IFN β-1b 250 μg SC every other day (Betaferon) Arm 2: IFN β-1a 30 μg IM once weekly (Avonex) | Randomised 92 arm 1 96 arm 2 |
Kappos 2011 RRMS (McDonald 2001) | Country: Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Italy, Mexico, Romania, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Ukraine, United Kingdom, USA and others No. of countries: 20 Centres: 79 Study period: Not specified. Up to 96 weeks follow up. Sponsor: F Hoffmann-La Roche Ltd., Biogen Idec Inc | Mean age 37.5 Mean sex: 65% female Race: 96% white EDSS Score: 3.3 Relapse rate: NA Time from diagnosis of MS: median only Other clinical features of MS: NA | Arm 1: IFN β-1a 30 μg IM once weekly (Avonex) Arm 2: placebo injection every other week | Randomised 55 arm 1 54 arm 2 |
Knobler 1993 RRMS (Poser) | Country: USA No. of countries: 1 Centres: 3 Study period: June and October 1986. Follow up 3 years (24 weeks of initial follow-up for the 5 groups then all the patients that had received 0.8 mU, 4MU and 16MU for 24 weeks received a dose of 8MU from week 24 to 3 years) Sponsor: Triton Biosciences, Inc. and Berlex Laboratories, Inc | Mean age 35.6 Mean sex: 48% female Race: NA EDSS Score: 3.1 Mean exacerbation in prior 2 years: 2.84 Time from diagnosis of MS: 6.6 years Other clinical features of MS: mean Scripps Neurological Rating Scale (NRS): 76.6 | Arm 1: IFN β-1b 250 μg SC every other day (Betaferon) Arm 2: Subcutaneous injection of placebo (1 mL like Betaseron 8 MU) | Randomised 6 arm 1 7 arm 2 |
MSCRG 1996 RRMS (Poser) | Country: USA No. of countries: 1 Centres: 4 Study period: November, 1990 to early 1993 2 years follow up for all-patients + 2 additional years for patients completing dosing before the end of the first period of follow-up. Sponsor: National Institutes of Health, National Institute of Neurological Disorders and Stroke (NINDS) grant R01–26321 and Biogen, Inc. | Mean age 36.8 Mean sex: 73.7% female Race: 93% white EDSS Score: 2.4 Relapse rate: 1.2 MS duration (years): 6.5 Other clinical features of MS: None | Arm 1: IFN β-1a 30 μg IM once weekly (Avonex) Arm 2: Placebo | Randomised 158 arm 1 143 arm 2 |
PRISMS 1998 RRMS (Poser) | Country: Australia, Belgium, Canada, Finland, Germany, Netherlands, Sweden, Switzerland, UK No. of countries: 9 Centres: 22 Study period: May 1994 to February 1995 with 2 years follow up. Sponsor: Ares- Serono | Mean age Median: 34.9 Mean sex: 69% female Race: NA EDSS Score: 2.5 (SD 1.2) Relapse rate: 3.0 (SD 1.2) Time from diagnosis of MS: Median: 5.3 years) Other clinical features of MS: NA | Arm 1: IFN β-1a 22 μg SC three times weekly (Rebif) Arm 2: IFN β-1a 44 SC three times weekly (Rebif) Arm 3: Placebo | Randomised 189 arm 1 184 arm 2 187 arm 3 |
REFORMS 2012 RRMS (McDonald 2005, Poser) | Country: USA No. of countries: 1 Centres: 27 Study period: December 2006–November 2007. 12 weeks follow up Sponsor: EMD Serono, Pfizer | Mean age 40.52 (SD 9.65) Mean sex: 70% female Race: 87.6% white EDSS Score: NA Relapse rate: 1.33 (SD 0.49) (of those with relapses) Time from diagnosis of MS: 1.47 yrs. (3.31) Other clinical features of MS: Percentage with no relapse in last 12 months: 24 (18.6%) Time since onset: 5.12 yrs. (6.68) Percentage diagnosed with Poser criteria: 36 (27.9%) Time since last relapse, of those with last-year relapses: 3.76 mos (2.93) Steroid treatment episodes: 0.50 (0.55) Percentage needing more than one course of steroids: 49 (38.0%) | Arm 1: IFN β-1a 44 SC three times weekly (Rebif) Arm 2: IFN β-1b 250 μg SC every other day (Betaferon) | Randomised 65 arm 1 64 arm 2 |
REGARD 2008 RRMS (McDonald 2001) | Country: Argentina, Austria, Brazil, Canada, France, Germany, Ireland, Italy, Netherlands, Russia, Spain, Switzerland, UK, and USA No. of countries: 14 Centres: 80 Study period: February and December 2004, with 96 weeks follow up Sponsor: EMD Serono, Pfizer | Mean age 36.8 Mean sex: 29.5% male Race: 93.6% white EDSS Score: 2.34 Relapse rate: Presented as distribution of relapses; months since last relapse about 5 on average Time from diagnosis of MS: Years since first relapse: 6.2 Other clinical features of MS: Receiving steroid treatment in last 6 months: 43.7% | Arm 1: IFN β-1a 44 SC three times weekly (Rebif) Arm 2: GA 20 mg SC daily (Copaxone) | Randomised 386 arm 1 378 arm 2 |