Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Location status: Recruiting
Location contact
Qiang Liu, M.D.,Ph.D.
CONTACT
Qiang Liu, M.D.,Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05792462
Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 1 / Phase 2
Tianjin, Tianjin Municipality, 300052, China
Location status: Recruiting
Qiang Liu, M.D.,Ph.D.
CONTACT
Qiang Liu, M.D.,Ph.D.
PRINCIPAL_INVESTIGATOR
The investigators primarily aim to observe the number of attacks from initiation of baricitinib treatment.
The secondary outcomes are to determine: The safety profile of baricitinib in participants with NMO and whether baricitinib improves Expanded Disability Status Scale (EDSS), et al.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Baricitinib will be taken orally with a dose of 4mg once daily until the disease relapses or week 48, with a final evaluation at week 52.
Time frame: From baseline to one year after
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
Time frame: Changes in EDSS from baseline to 52 weeks
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.
Time frame: 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
Time frame: From baseline to 52 weeks
Compare peripheral blood plasma cells before and one year after initial intervention
Time frame: From baseline to 52 weeks
Compare serum AQP4-ab titers before and one year after initial intervention
Time frame: From baseline to 52 weeks
Adverse events related to belimumab are recorded
Contact information is provided by the study sponsor or research team.
Tianjin Medical University General Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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