Table 1

Visit schedule

ActionScreening/baseline day 0 (−3 days)Therapy day 1Therapy day 2Therapy day 3Week 1 (±4 days)Week 4 (±4 days)Week 16 (±4 days)Week 26 (±7 days)Month 24 (±7 days)
Informed consentX
DemographicsX
Inclusion/exclusion criteriaX
Medical historyX
Present complaintsXXXXXXXXX
MS relapse/ON recurrenceXXXX
Concomitant medicationXXXXXXXXX
Physical examinationX*X*X*
Vital signs†X3 X3 X3 XXX
Body weightX*X*X*
ECGX*X*
Routine laboratory‡XXXX
Urinalysis (if clinically indicated)X*(X*)(X*)(X*)(X*)
Pregnancy testX*
EPO antibodies (analysis in central lab)XX
Aquaporin 4 antibodiesX
Methylprednisolone therapyX (standard of care)X (standard of care)X (standard of care)
EPO/placebo administrationXXX
AE reportingXXXXXXXX
Neurological examination, EDSS¶XXXXXX
RandomisationX
RefractionXXXXXX
OCTXXXXX
LCVAXXXXXX
HCVAXXXXXX
CSXXXXXX
PerimetryXXXXXX
NEI VFQ-25XXX
VEPXXXXX
Routine MRIX**X††(X)
  • *Test to be performed, but not recorded on CRF.

  • †CRF: only blood pressure.

  • ‡CRF: only haemoglobin (Hb).

  • §(S)AE: to be reported only if related to investigational product.

  • ¶CRF: only EDSS.

  • **Can be done after baseline as per local routine.

  • ††Recommended.

  • AE, adverse event; CS, contrast sensitivity; EDSS, Extended Disability Status Score; EPO, erythropoietin; HCVA, high-contrast visual acuity; LCVA, low-contrast visual acuity; MS, multiple sclerosis; NEI VFQ-25, National Eye Institute Visual Functioning Questionnaire 25; OCT, optical coherence tomography; ON, optic neuritis; VEP, visual evoked potentials.