Table 3.
Published and ongoing phase III trials in other MS phenotypes
| Trial name/group [registry numbera] | Publication date [start datea] | Treatment | MS phenotype [EDSS inclusion criterion] | Primary outcome measure(s) | Secondary and other outcome measures (disability-related) |
|---|---|---|---|---|---|
| Relapsing or progressive MS | |||||
| Mayo Clinic–Canadian Cooperative trial [60] | Nov 1998 | Sulfasalazine vs. placebo | Active RRMS or progressive MS [1.0–4.0] | Time to sustained (3-month) disability progression (EDSS increase ≥ 1) | Sustained (3-month) disability progression (EDSS increase ≥ 0.5) Treatment failure (sustained [3-month] disability progression [EDSS ≥ 2]) |
| Noseworthy et al. [61] | May 2000 | Roquinimex vs. placebo | Active RRMS or SPMS [3.0–6.5] | Time to sustained (3-month) disability progression on EDSSb | Sustained (3-month) disability progression on EDSS (proportion of patients)b |
| OPTIMUM [NCT02425644] | NA—study ongoing [Apr 2015] | Ponesimod vs. teriflunomide | RRMS or SPMS [≤ 5.5] | ARR | Sustained (3-month) disability progression on EDSSc |
| ASCLEPIOS II [NCT02792231] | NA—study ongoing [Aug 2016] | Ofatumumab vs. teriflunomide | RRMS or SPMS [≤ 5.5] | ARR | Sustained (3-month) disability progression on EDSSc Sustained (6-month) disability progression on EDSS Sustained (6-month) improvement in disability on EDSSc |
| ASCLEPIOS I [NCT02792218] | NA—study ongoing [Sep 2016] | Ofatumumab vs. teriflunomide | RRMS or SPMS [≤ 5.5] | ARR | Sustained (3-month) disability progression on EDSSc Sustained (6-month) disability progression on EDSSc Sustained (6-month) improvement in disability on EDSSc |
| Other | |||||
| MITOX-REBIF [NCT02937285] | NA—study ongoing [Nov 2010] | Mitoxantrone + interferon β-1a SC vs. interferon β-1a SC | Patients with a strong risk of progression in the initial phase of MS [> 3.5] | Absence of relapse and EDSS increase ≤ 1 | Change in EDSS score Rate of progression to clinically definite MS (in patients with one clinical event) |
Endpoints measuring the following parameters are not included as they do not necessarily capture disability: quality of life, fatigue, depression, psychological impairment, social impairment, hospitalisations and interventions for disease-related events; clinical global improvement was included as it is likely to capture disability in the progressive MS population
ARR annualised relapse rate, EDSS Expanded Disability Status Scale, MS multiple sclerosis, NA not applicable, RRMS relapsing-remitting multiple sclerosis, SC subcutaneous, SPMS secondary progressive multiple sclerosis
aIf available
bEDSS score increase ≥ 1.0 if baseline score ≤ 5.0, or ≥ 0.5 if ≥ 5.5
cNo further details given