Autoimmune EncephalitisCPINCT03542279
CPI Combination Therapy for Autoimmune Encephalitis
A study testing Plasma exchange (PE) and intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) in people with Autoimmune Encephalitis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Corticosteroids, intravenous immunoglobulin (IVIG), and plasma exchange (PE) are the first-line therapies for autoimmune encephalitis (AE) patients, but optimal first-line treatment strategy for different AE patients remains undetermined. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- Plasma exchange (PE) and intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2020to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 14-65 years old;
- met all the three following diagnostic criteria of AE: (i) subacute onset (rapid progress of less than 3 months) of working memory deficits, altered mental status, or psychiatric symptoms; (ii) at least one of the followings: new focal CNS findings, seizures not explained by a previously known disease, cerebrospinal fluid (CSF) pleocytosis (white blood cell count 5 cells/mm3), magnetic resonance imaging (MRI) features suggestive of encephalitis, and (iii) reasonable exclusion of alternative causes;
- the presence of antibody against neuronal surface antigen in serum or CSF indicating a positive diagnosis of AE using a cell-based assay;
- critically ill with a modified Rankin scale (mRS) score of 4 to 5;
- within 3 months of onset;
- no immunotherapy previously.
Who cannot join
- relative contraindications of TPE treatment: serious underlying diseases such as severe active hemorrhage, disseminated intravascular coagulation, severe hypotension or shock, unstable cardiac failure, cerebral herniation, severe infection or other endangered conditions;
- allergic to immunoglobulin;
- contraindications of glucocorticoid therapy: glucocorticoid allergy, active gastric or duodenal ulcer, severe osteoporosis, diabetes, hypertension after recent gastrointestinal anastomosis, and serious infection that cannot be controlled by antibiotics;
- serious underlying diseases, such as cardiac dysfunction, arrhythmia, and coagulation disorders;
- premorbid mRS ≥ 3.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Combination Therapy of Pulse Corticosteroid and Plasma Exchange Followed by Intravenous Immunoglobulin in Patients With Severe Antibody- Associated Autoimmune Encephalitis: a Randomized Controlled Trial
Corticosteroids, intravenous immunoglobulin (IVIG), and plasma exchange (PE) are the first-line therapies for autoimmune encephalitis (AE) patients, but optimal first-line treatment strategy for different AE patients remains undetermined. The study is to compare the efficacy between pulse corticosteroid plus PE initially followed by IVIG (CPI therapy) and pulse corticosteroid plus IVIG followed by PE two weeks later (CIP therapy) in patients with severe antibody-associated autoimmune encephalitis (AE).
Read the detailed description
Patients with AE will be randomly divided into the CPI and CIP group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes intravenous methylprednisolone (IVMP), intravenous immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. Patients in the CPI group received IVMP and PE treatment without delay, followed by IVIG immediately after PE treatment. Patients in the CIP group were given IVMP and IVIG and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment. The patients received long-term immunotherapy involving a combination of oral corticosteroids and immunosuppressants (such as mycophenolate mofetil at a dose of 1-2g/d) for 6-12 months if no contraindications. The primary outcome is the proportion of patients achieving functional improvement [a decrease of at least 1 point in modified Rankin Scale (mRS) score] at 3 months after immunotherapy.
- Conditions
- Autoimmune Encephalitis
- Being tested
- Plasma exchange (PE), intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)
- Keywords
- Autoimmune encephalitis, Plasma exchange, Immunotherapy, Outcome, corticosteroid, immunoglobulin
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchange (PE)Procedure or surgery
PE is performed every other day using a multi-filtrate apheresis device (Fresenius, Bad Homburg, Germany), and 5 times in total for each course. The plasma removed during PE is replaced with an equal volume of substitution (half 5% albumin with normal saline and half plasma). The plasma volume to be replaced was estimated according to the following formula: plasma volume (L) = 7.5%×weight (kg)×(1-hematocrit)×1000ml. Heparin was added to the exchange circuit to prevent blood clotting. The exchange rate was monitored, recorded, and balanced to prevent cardiovascular instability. Blood pressure and other vital signs were closely monitored every 15 minutes throughout the exchange.
intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)Drug
IVIG is given 0.4 g/kg/d for each course for 5 days. IVMP is 1,000 mg or 500 mg methylprednisolone for 3 or 5 days, and the dosage of glucocorticoid will gradually decrease.
| Study group | Role | What they receive |
|---|---|---|
| CPI group | Experimental | Intravenous methylprednisolone (IVMP) combined with PE (5 times in each course) and IVIG after PE. Receives: Procedure: Plasma exchange (PE); Drug: intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) |
| CIP group | Active comparator | IVMP and IVIG (0.4g/kg/d for 5 days) immediately, followed by PE at least 2 weeks after IVIG treatment. Receives: Procedure: Plasma exchange (PE); Drug: intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects achieving functional improvement
Functional improvement is defined as a decrease of at least 1 point in mRS score, modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 3 months following Immunotherapy
Secondary outcomes (13)
modified Rankin Scale
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 3 months following Immunotherapy
modified Rankin Scale
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 6 months following Immunotherapy
modified Rankin Scale
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 12 months following Immunotherapy
modified Rankin Scale
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 24 months following Immunotherapy
proportion of favorable outcome
A mRS score of 0-2 was considered a favorable outcome, whereas a mRS score of 3-6 was graded as an unfavorable one.
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 3 months following Immunotherapy
proportion of favorable outcome
A mRS score of 0-2 was considered a favorable outcome, whereas a mRS score of 3-6 was graded as an unfavorable one.
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 6 months following Immunotherapy
proportion of favorable outcome
A mRS score of 0-2 was considered a favorable outcome, whereas a mRS score of 3-6 was graded as an unfavorable one.
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 12 months following Immunotherapy
proportion of favorable outcome
A mRS score of 0-2 was considered a favorable outcome, whereas a mRS score of 3-6 was graded as an unfavorable one.
modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 24 months following Immunotherapy
CASE score
Clinical Assessment Scale in Autoimmune Encephalitis
Measured: 3 months following Immunotherapy
CASE score
Clinical Assessment Scale in Autoimmune Encephalitis
Measured: 6 months following Immunotherapy
CASE score
Clinical Assessment Scale in Autoimmune Encephalitis
Measured: 12 months following Immunotherapy
CASE score
Clinical Assessment Scale in Autoimmune Encephalitis
Measured: 24 months following Immunotherapy
Length of ICU stay
Length of ICU stay (days)
Measured: before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start25 Nov 2020
- Primary completion12 Dec 2022
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhang, Xuanwu Hospital, Beijing
- Investigators
- Yan Zhang, MD, Phd, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542279
- Sponsor's protocol ID
- AE-CPI
- Acronym
- CPI
- Status last verified
- Oct 2024
- First submitted
- 18 May 2018
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Pulse Corticosteroid and Plasma Exchange Followed by Intravenous Immunoglobulin in Patients With Severe Antibody- Associated Autoimmune Encephalitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03542279
- Acronym / sponsor ID
- CPI / AE-CPI
- Conditions
- Autoimmune Encephalitis
- Keywords
- Autoimmune encephalitis, Plasma exchange, Immunotherapy, Outcome, corticosteroid, immunoglobulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Corticosteroids, intravenous immunoglobulin (IVIG), and plasma exchange (PE) are the first-line therapies for autoimmune encephalitis (AE) patients, but optimal first-line treatment strategy for different AE patients remains undetermined. The study is to compare the efficacy between pulse corticosteroid plus PE initially followed by IVIG (CPI therapy) and pulse corticosteroid plus IVIG followed by PE two weeks later (CIP therapy) in patients with severe antibody-associated autoimmune encephalitis (AE).
Detailed description
Patients with AE will be randomly divided into the CPI and CIP group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes intravenous methylprednisolone (IVMP), intravenous immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. Patients in the CPI group received IVMP and PE treatment without delay, followed by IVIG immediately after PE treatment. Patients in the CIP group were given IVMP and IVIG and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment. The patients received long-term immunotherapy involving a combination of oral corticosteroids and immunosuppressants (such as mycophenolate mofetil at a dose of 1-2g/d) for 6-12 months if no contraindications. The primary outcome is the proportion of patients achieving functional improvement [a decrease of at least 1 point in modified Rankin Scale (mRS) score] at 3 months after immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPI group | Experimental | Procedure: Plasma exchange (PE), Drug: intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)Intravenous methylprednisolone (IVMP) combined with PE (5 times in each course) and IVIG after PE. |
| CIP group | Active comparator | Procedure: Plasma exchange (PE), Drug: intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)IVMP and IVIG (0.4g/kg/d for 5 days) immediately, followed by PE at least 2 weeks after IVIG treatment. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 14-65 years old;
- met all the three following diagnostic criteria of AE: (i) subacute onset (rapid progress of less than 3 months) of working memory deficits, altered mental status, or psychiatric symptoms; (ii) at least one of the followings: new focal CNS findings, seizures not explained by a previously known disease, cerebrospinal fluid (CSF) pleocytosis (white blood cell count 5 cells/mm3), magnetic resonance imaging (MRI) features suggestive of encephalitis, and (iii) reasonable exclusion of alternative causes;
- the presence of antibody against neuronal surface antigen in serum or CSF indicating a positive diagnosis of AE using a cell-based assay;
- critically ill with a modified Rankin scale (mRS) score of 4 to 5;
- within 3 months of onset;
Key exclusion criteria (5 listed)
- relative contraindications of TPE treatment: serious underlying diseases such as severe active hemorrhage, disseminated intravascular coagulation, severe hypotension or shock, unstable cardiac failure, cerebral herniation, severe infection or other endangered conditions;
- allergic to immunoglobulin;
- contraindications of glucocorticoid therapy: glucocorticoid allergy, active gastric or duodenal ulcer, severe osteoporosis, diabetes, hypertension after recent gastrointestinal anastomosis, and serious infection that cannot be controlled by antibiotics;
- serious underlying diseases, such as cardiac dysfunction, arrhythmia, and coagulation disorders;
- premorbid mRS ≥ 3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma exchange (PE)PE is performed every other day using a multi-filtrate apheresis device (Fresenius, Bad Homburg, Germany), and 5 times in total for each course. The plasma removed during PE is replaced with an equal volume of substitution (half 5% albumin with normal saline and half plasma). The plasma volume to be replaced was estimated according to the following formula: plasma volume (L) = 7.5%×weight (kg)×(1-hematocrit)×1000ml. Heparin was added to the exchange circuit to prevent blood clotting. The exchange rate was monitored, recorded, and balanced to prevent cardiovascular instability. Blood pressure and other vital signs were closely monitored every 15 minutes throughout the exchange. | Procedure or surgery | CIP group, CPI group |
| intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)IVIG is given 0.4 g/kg/d for each course for 5 days. IVMP is 1,000 mg or 500 mg methylprednisolone for 3 or 5 days, and the dosage of glucocorticoid will gradually decrease. | Drug | CIP group, CPI group |
Primary outcome
proportion of subjects achieving functional improvement
Time frame: 3 months following Immunotherapy
Functional improvement is defined as a decrease of at least 1 point in mRS score, modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
13 secondary outcomes
modified Rankin Scale
Time frame: 3 months following Immunotherapy
modified Rankin Scale
Time frame: 6 months following Immunotherapy
modified Rankin Scale
Time frame: 12 months following Immunotherapy
modified Rankin Scale
Time frame: 24 months following Immunotherapy
proportion of favorable outcome
Time frame: 3 months following Immunotherapy
proportion of favorable outcome
Time frame: 6 months following Immunotherapy
proportion of favorable outcome
Time frame: 12 months following Immunotherapy
proportion of favorable outcome
Time frame: 24 months following Immunotherapy
CASE score
Time frame: 3 months following Immunotherapy
CASE score
Time frame: 6 months following Immunotherapy
CASE score
Time frame: 12 months following Immunotherapy
CASE score
Time frame: 24 months following Immunotherapy
Length of ICU stay
Time frame: before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Zhang, MD, Phd study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma exchange (PE) and intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) in people with Autoimmune Encephalitis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of subjects achieving functional improvement (time frame: 3 months following Immunotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.