Actively Recruiting
Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
Led by Beijing Tongren Hospital · Updated on 2024-11-20
10
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis. Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.
CONDITIONS
Official Title
Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older, male or female
- Symptoms of autoimmune encephalitis lasting 9 months or less before enrollment
- Diagnosis of autoimmune encephalitis with rapid onset (less than 3 months) of at least four major symptoms such as abnormal behavior, speech dysfunction, seizures, movement disorders, decreased consciousness, or autonomic dysfunction
- Positive anti-NMDAR IgG antibody in cerebrospinal fluid or positive anti-LGI1 antibody in serum or cerebrospinal fluid
- Reasonable exclusion of other causes and well-defined encephalitis syndromes
- Refractory autoimmune encephalitis with ineffective treatment from steroids and rituximab or other immunosuppressants and stable modified Rankin Scale score of 2 or higher for at least 24 hours
- Recurrent autoimmune encephalitis with new or worsening symptoms at least 2 months after prior treatment and increase in modified Rankin Scale score by more than 1
- Stable doses of steroids and other immunosuppressants for 4 weeks before enrollment
- Ability to provide informed consent or have a proxy provide consent
- Women of childbearing potential must use effective contraception during treatment and for at least 3 months after last dose of Telitacicept or avoid heterosexual intercourse
You will not qualify if you...
- History of other autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's syndrome; hyperthyroidism and hypothyroidism are not excluded
- Abnormal laboratory values including low white blood cell count, low neutrophil count, low hemoglobin, low platelet count, elevated serum creatinine, total bilirubin, liver enzymes, alkaline phosphatase, or creatine kinase
- Evidence of active infection such as shingles, HIV, or active tuberculosis
- Active hepatitis or severe liver disease or history of such; positive hepatitis B surface antigen or certain hepatitis B markers with positive HBV-DNA; positive hepatitis C antibody
- Uncontrolled diabetes with high glycosylated hemoglobin or fasting blood glucose
- Received live vaccine within 3 months prior to enrollment or planned vaccination during study
- Received rituximab or other biological therapies within 1 month prior to enrollment
- Presence of malignancy
- Allergy to human biological products
- Participation in another clinical trial within 28 days or within five times the half-life of investigational drug
- Pregnancy, breastfeeding, or planning to have children during the trial
- Alcohol or drug abuse affecting compliance
- Deemed unsuitable by investigator due to severe mental disorders or other reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
Jiawei Wang, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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