drugset / Trial / NCT02398994
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis
Phase 3
Terminated
2 enrolled
Guy's and St Thomas' NHS Foundation Trust
Alder Hey Children's NHS Foundation Trust · collabBarts & The London NHS Trust · collabBarts and the London School of Medicine and Dentistry · collabBirmingham Women's and Children's NHS Foundation Trust · collabCardiff University · collabCardiff and Vale University Health Board · collabGreat Ormond Street Hospital for Children NHS Foundation Trust · collabKing's College Hospital NHS Trust · collabKing's College London · collabManchester University NHS Foundation Trust · collabNHS Lothian · collabNewcastle-upon-Tyne Hospitals NHS Trust · collabNorth Bristol NHS Trust · collabNorthern Care Alliance NHS Foundation Trust · collabNottingham University Hospitals NHS Trust · collabOxford University Hospitals NHS Trust · collabUniversity College, London · collabUniversity Hospital Birmingham NHS Foundation Trust · collabUniversity Hospital Southampton NHS Foundation Trust · collabUniversity Hospitals Bristol and Weston NHS Foundation Trust · collabWalton Centre NHS Foundation Trust · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This multi-center randomized controlled trial evaluates if the addition of intravenous immunoglobulin to standard treatment of corticosteroids improves outcome in children and adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Half of participants will receive corticosteroids alone, whilst the other half will receive corticosteroids plus intravenous immunoglobulin.
Timeline
- Start
- 2015-03
- Primary completion
- 2016-03
- Completion
- 2016-03
Publications
- Absoud M, Brex P, Ciccarelli O, Diribe O, Giovannoni G, Hellier J, Howe R, Holland R, Kelly J, McCrone P, Murphy C, Palace J, Pickles A, Pike M, Robertson N, Jacob A, Lim M. A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin compared with standard therapy for the treatment of transverse myelitis in adults and children (STRIVE). Health Technol Assess. 2017 May;21(31):1-50. doi: 10.3310/hta21310.
- Absoud M, Gadian J, Hellier J, Brex PA, Ciccarelli O, Giovannoni G, Kelly J, McCrone P, Murphy C, Palace J, Pickles A, Pike M, Robertson N, Jacob A, Lim M. Protocol for a multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin versus standard therapy for the treatment of transverse myelitis in adults and children (STRIVE). BMJ Open. 2015 May 25;5(5):e008312. doi: 10.1136/bmjopen-2015-008312.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 30 mg/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 1 g | Intravenous |