Table 1.
Timeline of trial interventions
| Schedule Treatment day (TD) Time point (T) |
T0 (Screening, baseline and prediagnosis tests) | T1 (Treatment and discharge) |
T2 3M | T3 6M | T4 12M | Withdrawal | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TD 1* | TD 2 | TD 3 | TD 4 | TD 5 | Rescue therapy† | Discharge | ||||||
| Screening with diagnostic algorithm and core investigations including physical examination | X | |||||||||||
| Patient information and informed consent | X | |||||||||||
| Eligibility form | X | |||||||||||
| Registration form | X | |||||||||||
| Prediagnosis tests—for example, MRI and AQP4 | X | |||||||||||
| Randomisation | X | |||||||||||
| Biobank samples | X | X | ||||||||||
| ASIA Impairment Score (A-E) | X | X | X | X | P | X | ||||||
| ASIA Motor and Sensory Score | X | X | X | X | S | X | ||||||
| Neurostatus scoring (Kurtzke functional systems and EDSS) | X | X | X | S | X | |||||||
| 8–12 years EQ-5D-Y | X | X | S | X | ||||||||
| ≥13 years EQ-5D-5L | X | X | S | X | ||||||||
| ≥13 years SCI QoL Basic data set | X | S | X | |||||||||
| CSRI | X | S | X | |||||||||
| ≥13 years SCI Bladder | T | X | ||||||||||
| ≥13 years SCI Bowel | T | X | ||||||||||
| 5–7 years Peds QL | T | X | ||||||||||
| 2–4 years Peds QL | T | X | ||||||||||
| Treatment form | X | |||||||||||
| Concomitant medications | X | X | X | X | ||||||||
| Discharge form | X | |||||||||||
| Rescue therapy form (if needed)† | X | |||||||||||
| Relapse form (at any time point if needed)† | X | X | X | X | ||||||||
| Adverse events‡ | X | X | X | X | X | |||||||
| Study Status Form | X | X | X | |||||||||
| Withdrawal form (at any time point)† | X | |||||||||||
*Treatment day 1: IVIG treatment (if applicable) to start on the same day as randomisation. Steroids may be started up to 5 days prior to randomisation.
†Rescue therapy, relapse and withdrawal forms may only be necessary for a small subset of patients.
‡Adverse events will be collected throughout the study.
ASIA, American Spinal Injury Association; AQP4, aquaporin-4; CSRI, Client Service Receipt Inventory; EDSS, expanded disability status scale; Peds QL, Pediatric Quality of Life Inventory; P, primary outcome measure; S, secondary outcome measure; SCI, Spinal Cord Injury; T, tertiary outcome measure.