Efficacy of Ocrelizumab in Autoimmune Encephalitis
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/13/2019 |
Start Date: | January 22, 2019 |
End Date: | January 22, 2022 |
Contact: | Steven Hopkins |
Email: | steve.hopkins@utsouthwestern.edu |
Phone: | 2146489275 |
Exploratory Study of Efficacy of Ocrelizumab in Autoimmune Encephalitis
This pilot study is a randomized, double-blind, placebo controlled study of the efficacy of
ocrelizumab in autoimmune encephalitis. Subjects with new diagnosis of autoimmune
encephalitis will be invited to enroll in this study. Subjects will be randomized to receive
ocrelizumab (an anti-CD20 therapy)or matched placebo, and will undergo three infusions over a
six month period. Subjects will complete clinical visits over the study period, during which
safety monitoring and neuropsychological assessments will be performed to assess for signs of
clinical worsening from encephalitis. The primary outcome of this study is the proportion of
patients who fail to complete the twelve month period without clinical worsening, as defined
by the protocol. Subjects who experience early clinical worsening during the study may be
offered open-label treatment with ocrelizumab at the discretion of the investigators.
ocrelizumab in autoimmune encephalitis. Subjects with new diagnosis of autoimmune
encephalitis will be invited to enroll in this study. Subjects will be randomized to receive
ocrelizumab (an anti-CD20 therapy)or matched placebo, and will undergo three infusions over a
six month period. Subjects will complete clinical visits over the study period, during which
safety monitoring and neuropsychological assessments will be performed to assess for signs of
clinical worsening from encephalitis. The primary outcome of this study is the proportion of
patients who fail to complete the twelve month period without clinical worsening, as defined
by the protocol. Subjects who experience early clinical worsening during the study may be
offered open-label treatment with ocrelizumab at the discretion of the investigators.
Inclusion Criteria:
1. Age 18 or greater
2. Able to obtain informed consent from patient or appropriate designee
3. Possible autoimmune encephalitis as defined by Table 1:
1. Reasonable exclusion of alternative causes
2. Subacute onset (< 3 months) of memory deficits, altered consciousness, and/or
psychiatric symptoms
3. One or more of the following:
- CSF (cerebrospinal fluid) pleocytosis (>5 cells/µl corrected, if necessary,
for traumatic lumbar puncture)
- EEG (electroencephalogram) with epileptiform or focal slow wave
abnormalities involving temporal lobes
- Brain abnormalities on T2/FLAIR MRI restricted to the mesial temporal
(limbic) lobes
- Associated dyskinesias (faciobrachial dystonic movements or orofacial
dyskinesias)
4. Completed initial treatment with iv steroids (at least 3000mg solumedrol) and plasma
exchange (at least 3 exchanges) within the past 8 weeks
5. Presence of one (or more) of the following autoantibodies in serum or CSF
- NMDA receptor
- LGI1
- CASPR2
- DPPX
Exclusion Criteria:
1. Prior immunosuppression treatment in past year (other than steroids and plasma
exchange)
2. Treatment with intravenous immunoglobulin in past year
3. Active malignancy requiring chemotherapy
4. Pregnancy
5. Evidence of active hepatitis or tuberculosis infection
6. Medical condition that (in investigators opinion) precludes the use of ocrelizumab
We found this trial at
1
site
2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Steven Vernino, MD, PhD
Phone: 214-648-9275
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