Actively Recruiting
Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders
Led by Tianjin Medical University General Hospital · Updated on 2024-10-16
12
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University General Hospital
Lead Sponsor
T
Tang-Du Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older
- Diagnosis of Neuromyelitis Optica or Neuromyelitis Optica Spectrum Disorder based on 2015 criteria
- At least one attack requiring rescue therapy in the past year or at least two attacks in the past two years
- Expanded Disability Status Scale (EDSS) score of 6.0 or less
- Positive for AQP4-IgG antibodies
- Able and willing to give written informed consent and follow study requirements
You will not qualify if you...
- Current or past significant infections such as Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, HIV, hepatitis viruses, or syphilis
- Participation in another interventional trial within the last 3 months
- Current or recent tumor disease within the last 5 years
- Pregnant, breastfeeding, or of childbearing potential during the study
- Heart, liver, kidney, or bone marrow disorders that are clinically relevant
- History of venous thromboembolism (VTE) or high risk for VTE
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
Research Team
Q
Qiang Liu, M.D.,Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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