Efficacy of Ocrelizumab in Autoimmune Encephalitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03835728|
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : November 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Encephalitis||Drug: Ocrelizumab Drug: Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Exploratory Study of Efficacy of Ocrelizumab in Autoimmune Encephalitis|
|Actual Study Start Date :||January 22, 2019|
|Actual Primary Completion Date :||October 2, 2020|
|Actual Study Completion Date :||October 2, 2020|
Active Comparator: Treatment Arm
Ocrelizumab will be administered 3 times over a 1 year study period. Subjects will receive a dose of 300 mg at week 0 (baseline) and again at week 2. The final dose of 600 mg will be administered at week 24.
Subjects will be randomized in a 1:1 fashion to receive infusion of Ocrelizumab (2 doses at 300 mg and 1 dose at 600 mg) or matched placebo. The 2 300 mg doses will be administered at day 2 and day 14. The 600 mg dose will be administered during the 6 month visit. The drug will be administered via infusion three times throughout the trial period: after the initial screening, at two weeks from initial infusion, and at 6 months.
Placebo Comparator: Treatment Placebo Arm
Saline will be used as the matching placebo
This will be the matching placebo used in the study.
- failure rate [ Time Frame: 12 months ]The primary outcome of the treatment trial will be the proportion of patients who fail to complete the 12 month study without clinical worsening.
- Treatment failure [ Time Frame: 12 months ]Secondary outcome will be time to treatment failure.
- change in TFLS (Texas Functional Living Scale) scores [ Time Frame: 6-12 months ]
Secondary outcome: TFLS (Texas Functional Living Scale) scores at 6 and 12 months compared to baseline. - A performance-based measure of functional competence designed to assess instrumental activities of daily living (e.g., managing money) that are thought to be more susceptible to cognitive change than basic activities of daily living (e.g., dressing).
Content and Structure: The TFLS is comprised of 24 items divided into four subscales assessing abilities related to Time, Money and Calculation, Communication, and Memory. Many items provide a range of possible points allowing the instrument to account for the varying levels of functioning that may be observed in clinical populations.
Total raw score ranges between 0 and 50 with standardized T-score values between 20 and 66. The higher the score, the better the performance.
Time: 0-9 Money and Calculation: 0-8 Communication: 0-28 Memory: 0-5
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835728
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Steven Vernino, MD, PhD||UT Southwestern Medical Center|