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
N/A
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) involve an abnormal immune response targeting the aquaporin-4 water channel. Researchers are evaluating the effects of baricitinib, an oral medication that blocks a key immune pathway, in people with NMOSD. This study aims to observe the number of attacks and assess the safety and disability changes related to baricitinib treatment in affected patients. Participants will take baricitinib orally at a dose of 4 mg once daily until either their disease relapses or for up to 48 weeks, with a final evaluation at week 52. The study focuses on one treatment group receiving baricitinib. There are no placebo or comparator groups mentioned, and the treatment is monitored throughout the study period. During the study, participants will be assessed for the number of NMOSD attacks, changes in disability status using the Expanded Disability Status Scale (EDSS), and MRI scans of the optic nerve, brain, and spinal cord. Blood tests will monitor B cell subsets and serum AQP4 antibodies. Safety will be evaluated by recording any treatment-emergent adverse events over the 52-week period. Participants are expected to comply with study protocols and provide informed consent prior to enrollment.
CONDITIONS
Brief 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
- Diagnosed with Neuromyelitis Optica or Neuromyelitis Optica Spectrum Disorder according to the 2015 International Panel criteria
- Clinical evidence of at least one attack requiring rescue therapy in the past year or two attacks in the past two years
- Expanded Disability Status Scale (EDSS) score of 6.0 or less
- Seropositive for AQP4-IgG antibodies
- Able and willing to provide written informed consent and comply with study requirements
You will not qualify if you...
- Current or known history of 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 child-bearing potential during the study
- Clinically relevant disorders of heart, liver, kidney, or bone marrow function
- History of venous thromboembolism or considered at high risk for venous thromboembolism by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants take Baricitinib orally once daily until the disease relapses or up to week 48.
Regular visits during treatment period
Duration - 4 weeks
Participants have a final evaluation at week 52 after treatment ends.
1 visit (in-person)
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.
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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