drugset / Trial / NCT01071083
Treatment Interruption of Natalizumab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab. The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks: * when MS symptoms return, and * if other drugs for MS may help control MS symptoms during the natalizumab-interruption period. This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-11
- Completion
- 2011-11
Publications
- Fox RJ, Cree BAC, de Seze J, Gold R, Hartung HP, Jeffery D, Kappos L, Montalban X, Weinstock-Guttman B, Singh CM, Altincatal A, Belviso N, Avila RL, Ho PR, Su R, Engle R, Sangurdekar D, de Moor C, Fisher E, Kieseier BC, Rudick RA. Temporal Relationship Between Serum Neurofilament Light Chain and Radiologic Disease Activity in Patients With Multiple Sclerosis. Neurology. 2024 May 14;102(9):e209357. doi: 10.1212/WNL.0000000000209357. Epub 2024 Apr 22.
- Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glatiramer Acetate | Small molecule | 20 mg | Subcutaneous |
| Comparator | Interferon beta-1a | Protein / enzyme biologic | 30 ug | Intramuscular |
| Comparator | Methylprednisolone | Other / unclassified | 1000 mg | Intravenous |
| Comparator | natalizumab | Monoclonal antibody | 300 mg | Intravenous |