MONICA
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Mycophenolate mofetil
Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
- Prednisone
Glucocorticoid receptor agonist
What it measured
Main measures
Annualized relapse rate day 360
day 360 after staring treatment
Relapses
Other measures (5)
expanded disability status scale
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
Disability progressionHauser scale
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
vision scale
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
VisionLesions in brain and spinal cord
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
MRI lesionsAnnualized relapse rate
day 1, 14, 30, 90, 180, 270 after staring treatment
Relapses
Who could take part
NMOSD · 18 to 65
Inclusion Criteria: * Meet the 2006 Wingerchuk diagnostic criteria; * NMO-immunoglobulin G seropositive; * Between 18 to 65 years old; * Relapse: more than 2 relapses in recent 2 years; more than 1 relapses in recent 1 years; * Expanded disability status scale: expanded disability status scale≤7.0, and visual acuity ≥20 / 100 at least in one eye * Understand the purpose and procedures of this study, and written informed consent is obtained. Exclusion Criteria: * Using immunosuppressive agents and other drugs affect evaluation, and drug withdrawal less than 3 months; * Patients with any of the following diseases: transaminases elevation exceed 2 times of the normal upper limit; white blood cell \<4 × 109 / L, Hemoglobin \<80g / L, platelet \<100 × 109 / L; * With serious cardiovascular, liver, kidneys and other vital organs and blood, endocrine system diseases, cancer history; * With immunodeficiency, uncontrolled infection and active gastrointestinal diseases (such as gastric ulcer, etc.); * Pregnancy, breast-feeding women and male or female who plans to conceive recently; * Allergy to mycophenolate mofetil and prednisone.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central nervous system that leads to blindness and paralysis. Since disability accrues incrementally related to attacks, attack prevention with immunosuppressive therapy is the mainstay of preventing disability. However, there is no standard immunosuppressive treatment strategy for NMO relapse prevention. In a previous study, the investigators provided evidence supporting the use of azathioprine plus a low dose corticosteroid as an effective strategy which is associated with a reduction in the risk of relapse in Chinese patients with NMO, but azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In recent years, MMF has been used in different immune-related neurological diseases; some literature shown the possible efficacy of MMF in NMO treatment. In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University, Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil therapy in NMO spectrum disorders.
Papers
Results
Falcini F, Trapani S, Ricci L, Resti M, Simonini G, de Martino M. Sustained improvement of a girl affected with Devic's disease over 2 years of mycophenolate mofetil treatment. Rheumatology (Oxford). 2006 Jul;45(7):913-5. doi: 10.1093/rheumatology/kei263. Epub 2006 Apr 25. No abstract available.Results
Huh SY, Kim SH, Hyun JW, Joung AR, Park MS, Kim BJ, Kim HJ. Mycophenolate mofetil in the treatment of neuromyelitis optica spectrum disorder. JAMA Neurol. 2014 Nov;71(11):1372-8. doi: 10.1001/jamaneurol.2014.2057.Results
Jacob A, Matiello M, Weinshenker BG, Wingerchuk DM, Lucchinetti C, Shuster E, Carter J, Keegan BM, Kantarci OH, Pittock SJ. Treatment of neuromyelitis optica with mycophenolate mofetil: retrospective analysis of 24 patients. Arch Neurol. 2009 Sep;66(9):1128-33. doi: 10.1001/archneurol.2009.175.Results
Huang Q, Wang J, Zhou Y, Yang H, Wang Z, Yan Z, Long Y, Yin J, Feng H, Li C, Lu Z, Hu X, Qiu W. Low-Dose Mycophenolate Mofetil for Treatment of Neuromyelitis Optica Spectrum Disorders: A Prospective Multicenter Study in South China. Front Immunol. 2018 Sep 11;9:2066. doi: 10.3389/fimmu.2018.02066. eCollection 2018.
Loading reviews and guidelines…
Related trials
- A Safety and Tolerability Study of CC- 97540 (BMS-086353)…
Phase 1 · Not yet recruiting
Still running
- ELITE
Phase 3 · Recruiting
Still running
- EASE-NMO
Phase 2 · Running, not recruiting
Still running
- EASE-NMO
Phase 2 · Withdrawn
Stopped early
- FACT
Phase 2 · Status unknown
No result found
- Efgartigimod in Acute Neuromyelitis Optica Spectrum Disor…
Status unknown
No result found
History
Started
Jan 2016
Main results due
Dec 2017
Finished
Dec 2017
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error