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We are doing a clinical study of Baritinib in Neuromyelitis Optica Spectrum Disorders, similar to this one, so the study was withdrawn.
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Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Rucotinib is an oral inhibitor of JAK1 and JAK2 tyrosine kinases. It may benefit some patients with NMOSD due to the important role of JAK/STAT signaling pathway in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib | Experimental | Treatment with ruxolitinib will be initiated in an initial dose regimen of 5-10 mg twice daily. Two months later, the dose of ruxolitinib will be increased to 10-15 mg twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Treatment with ruxolitinib will be initiated in an initial dose regimen of 5-10 mg twice daily. Two months later, the dose of ruxolitinib will be increased to 10-15 mg twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| time to the first protocol-defined relapse | An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack. | From baseline to one year after. |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening in EDSS | The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10. | Worsening from baseline in EDSS to 52 weeks |
| Incidence of treatment-emergent adverse events [safety and tolerability] |
| Measure | Description | Time Frame |
|---|---|---|
| Counts of peripheral blood B cell subsets | Compare peripheral blood plasma cells before and one year after initial intervention. | From baseline to 52 weeks |
| Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Optic nerve,brain and spinal cord Magnetic Resonance Imaging (MRI) |
Inclusion Criteria:
Male or female patients ≥ 18 years old; Diagnosis of NMO or NMO spectrum disorder according to the 2015 International diagnostic criteria for neuromyelitis optic; Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months; EDSS <= 6.0; Rituximab should be used for at least 3 months if the condition is stable; Able and willing to give written informed consent and comply with the requirements of the study protocol.
Exclusion Criteria:
Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc); Participation in another interventional trial within the last 3 months; Patients taking oral immunosuppressants such as azathioprine; Tumor disease currently or within last 5 years; Pregnant, breastfeeding, or child-bearing potential during the course of the study; Clinically relevant anemia, thrombocytopenia and dysfunction of the heart, liver, kidney or bone marrow.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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Adverse events related to ruxolitinib are recorded |
| From baseline to 52 weeks |
The total number of new and/or enlarging T2 lesions for all participants was calculated as the sum of the individual number of lesions at Weeks 12, 24, and 52. |
| From baseline to 52 weeks |
| Determination of serum AQP4 antibodies | Compare serum AQP4-ab titers before and one year after initial intervention. | From baseline to 52 weeks |