Trial · NCT03835728
Efficacy of Ocrelizumab in Autoimmune Encephalitis
NCT03835728, Phase 2, Terminated, University of Texas Southwestern Medical Center; results first posted 2021-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Ocrelizumab in Autoimmune Encephalitis. Trials, record NCT03835728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03835728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Ocrelizumab in Autoimmune Encephalitis
- NCT number
- NCT03835728
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Autoimmune Encephalitis
- Interventions
- Ocrelizumab, Saline
- First posted
- 2019-02-11
- Last updated
- 2021-10-19
- Results first posted
- 2021-10-19
- Limitations and caveats
- Early termination of trial due to inadequate recruitment. Small numbers of subjects prevents definitive analysis of results
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Had Clinical Worsening | 12 months | The number of participants who had clinical worsening within 12 months. |
| Secondary | Time to Treatment Failure | 12 months | Definition of clinical worsening (treatment failure): 1. Clinician or patient/caregiver perception of clinical decline 2. Worsening of patient/family reported IADL (by one point or more) 3. One of the following additional features: * Significant worsening of Texas Functional Living Scale (by ≥ 5 T points, 0.5 st deviation) * Other clinical worsening leading to hospitalization |
| Secondary | Change in TFLS T-score (Texas Functional Living Scale) Score at 6 Months | Baseline, 6 month | Change in TFLS T-score (Texas Functional Living Scale) scores at 6 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. Change in TFLS T-score was used in this study |
| Secondary | Change in TFLS T Score (Texas Functional Living Scale) Score at 12 Months | Baseline, 12 months | Change in TFLS T-score (Texas Functional Living Scale) scores at 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. Change in TFLS T-score was used in this study |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Had Clinical Worsening | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Treatment Failure | 12 months | There were no treatment failures in the treatment arm. Thus, there was no data for this secondary outcome measure in the treatment arm | weeks | NUMBER |
| SECONDARY | Change in TFLS T-score (Texas Functional Living Scale) Score at 6 Months | Baseline, 6 month | Participant in placebo arm met study endpoint prior to 6 month outcome measure so change in TFLS score at 6 months was not analyzable for efficacy purposes. | score on a scale | MEDIAN |
| SECONDARY | Change in TFLS T Score (Texas Functional Living Scale) Score at 12 Months | Baseline, 12 months | Participant in placebo arm met study endpoint prior to 6 month outcome measure so change in TFLS score at 12 months was not analyzable for efficacy purposes. | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Had Clinical Worsening | Treatment Arm | 0 | Participants | ||
| Number of Participants Who Had Clinical Worsening | Treatment Placebo Arm | 1 | Participants | ||
| Time to Treatment Failure | Treatment Placebo Arm | 12 | weeks | ||
| Change in TFLS T-score (Texas Functional Living Scale) Score at 6 Months | Treatment Arm | 12.75 | Full Range 3 to 22.5 | score on a scale | |
| Change in TFLS T Score (Texas Functional Living Scale) Score at 12 Months | Treatment Arm | 24.5 | Full Range 3 to 46 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm | 2 | |
| Overall Study | STARTED | Treatment Placebo Arm | 1 | |
| Overall Study | COMPLETED | Treatment Arm | 2 | |
| Overall Study | COMPLETED | Treatment Placebo Arm | 1 | |
| Overall Study | NOT COMPLETED | Treatment Arm | 0 | |
| Overall Study | NOT COMPLETED | Treatment Placebo Arm | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | rash | Skin and subcutaneous tissue disorders | Treatment Arm | 2 | 2 | 2 |
| other | rash | Skin and subcutaneous tissue disorders | Treatment Placebo Arm | 1 | 1 | 1 |
| other | Elevated transaminases | Hepatobiliary disorders | Treatment Arm | 1 | 2 | 1 |
| other | Elevated transaminases | Hepatobiliary disorders | Treatment Placebo Arm | 0 | 1 | 0 |
| other | Seizures | Nervous system disorders | Treatment Arm | 2 | 2 | 2 |
| other | Seizures | Nervous system disorders | Treatment Placebo Arm | 0 | 1 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm | 0 | 2 |
| Total, all-cause mortality | Treatment Placebo Arm | 0 | 1 |
| Total, other adverse events | Treatment Arm | 2 | 2 |
| Total, other adverse events | Treatment Placebo Arm | 1 | 1 |
| Total, serious adverse events | Treatment Arm | 0 | 2 |
| Total, serious adverse events | Treatment Placebo Arm | 0 | 1 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Arm vs Treatment Placebo Arm: deaths from any cause | Trial comparisons |
| Treatment Arm vs Treatment Placebo Arm: Number of Participants Who Had Clinical Worsening | Trial comparisons |
| Treatment Arm vs Treatment Placebo Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03835728
GET https://conductscience.org/api/trials/v1/NCT03835728/registered