Systemic Lupus ErythematosusPhase 4MRBSNCT04893161
A Model About the Response of Belimumab in SLE
A Phase 4 study testing Belimumab in people with Systemic Lupus Erythematosus, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
A prospective, single-center cohort study aims to determine a predictive model of the response of belimumab at Week 48. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Belimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Jan 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfillment of the 1997 American College of Rheumatology (ACR) revised criteria for SLE;
- Aged more than 18 years;
- Active (according to SLEDAI-2K) and refractory SLE manifestations. SLE manifestations are defined as refractory in case of drug intolerance, unresponsiveness, or disease relapse in patients treated with corticosteroids, antimalarials, and/or immunosuppressants. Patients with renal disease were considered as refractory when they had a persistence of 24 hours proteinuria > 1 g after at least 1 year from the start of the initial therapy or when they experienced a renal flare (24 hours proteinuria > 1 g in case of previous complete response or doubling 24 hours proteinuria in other cases) during the subsequent therapy.
Who cannot join
- Have a history of malignant neoplasm within the last 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years;
- Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, poses a significant suicide risk;
- Have a history of a primary immunodeficiency;
- Have a significant IgG deficiency (IgG level < 400 mg/dL);
- Have an IgA deficiency (IgA level < 10 mg/dL)
- Have cyclophosphamide or rituximab treatment.
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- Infection history:
- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) Hospitalization for treatment of infection within 60 days of Day 0; Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Day 0.
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to Day 0;
- Have a historically positive HIV test or test positive at screening for HIV;
- Hepatitis status:
- Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows:
- Patients positive for HBsAg or HBcAb are excluded Positive test for Hepatitis C antibody
- Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies;
- Have any other clinically significant abnormal laboratory value in the opinion of the investigator;
- Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Model to Early Predict the Response of Belimumab Treatment in the Patients With Systemic Lupus Erythematosus
A prospective, single-center cohort study aims to determine a predictive model of the response of belimumab at Week 48.
Read the detailed description
Preamble:
Belimumab is an inhibitor of B cell activating factor (BAFF) that has been developed as an agent for the treatment of patients with systemic lupus erythematosus (SLE).
In July 2019, belimumab was approved for marketing in China. The belimumab treatment has been proved to reduce the level of autoantibodies and control disease activity in the patients with SLE. The response rate of SLE Responder Index-4 (SRI-4) is approximately 50% in the BLISS-52 and BLISS-76 phase III clinical trials. The goal of this study is to establish a predictive model (including immune marker, inflammatory biomarker and clinical factor) to early estimate the response of belimumab treatment.
Objectives:
Primary objective: in the patients with SLE, an early predictive model of the response of belimumab treatment will be estimated.
Secondary objectives:
In subjects with SLE receiving belimumab treatment, to assess the effect of belimumab on:
The clinical improvement; The serological variables improvemen. The inflammatory biomarkers improvemen. The quality of life. The dosage of prednisone. The kinetics of B cell phenotype. The function of non-switched memory B cells. The association between the immune, inflammatory and clinical markers and the response of belimumab.
The mechanism of BAFF inhibition on the survival and selection of SLE non-switched memory B cells.
The recovering of immune checkpoint in non-switched memory B cells from the view of BCR mutation.
The rates of adverse events.
Overview of study design:
This is a prospective, single-center cohort study to estimate a predictive model of the response of belimumab. All patients with SLE receive belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48. All patients are evaluated at week 0, 2, 4, 8, 12, 24, 36, and 48. The immune markers, inflammatory biomarkers, clinical markers and safety data are assessed following belimumab treatment.
Study population:
Men or women with SLE who have active (according to SLEDAI-2K) and refractory SLE manifestations. SLE manifestations are defined as refractory in case of drug intolerance, unresponsiveness, or disease relapse in patients treated with corticosteroids, antimalarials, and/or immunosuppressants. Patients with renal disease were considered as refractory when they had a persistence of 24 hours proteinuria > 1 g after at least 1 year from the start of the initial therapy or when they experienced a renal flare (24 hours proteinuria > 1 g in case of previous complete response or doubling 24 hours proteinuria in other cases) during the subsequent therapy.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Belimumab
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelimumabDrug
Also called The standard care
All patients with SLE will be enrolled in one year and administrated belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48.
| Study group | Role | What they receive |
|---|---|---|
| belimumab | Other | All patients with SLE receive belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48. The patients who had SRI-4 response at week 48 were divided into response group and the patients without SRI-4 response at week 48 were divided into no response group. Receives: Drug: Belimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of predictive model to assess the SRI response rate.
An SRI response is defined as a ≥ 4-point reduction in SELENA-SLEDAI score, no new BILAG A organ domain score and no more than 1 new BILAG B score, and no worsening (increase < 0.3) in PGA score versus baseline.
Measured: at week 48
Secondary outcomes (2)
The SRI-4 response rate
An SRI response is defined as a ≥ 4-point reduction in SELENA-SLEDAI score, no new BILAG A organ domain score and no more than 1 new BILAG B score, and no worsening (increase < 0.3) in PGA score versus baseline.
Measured: at week 48
The rate of adverse events
all adverse events
Measured: week 0 to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jun 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients with SLE will be enrolled in one year and administrated belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan He, Dr., Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893161
- Sponsor's protocol ID
- XJTU1AF2020LSK-278
- Acronym
- MRBS
- Status last verified
- Jan 2023
- First submitted
- 16 May 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Ju B, Zhu L, Li H, Luo J, Zhang J, Hu N, Mo L, Wang Y, Pan Y, Huang J, Lv X, Pu D, Hao Z, He L, Li Y. The rapid inhibition of B-cell activation markers by belimumab was associated with disease control in systemic lupus erythematosus patients. Front Pharmacol. 2023 Feb 16;14:1080730. doi: 10.3389/fphar.2023.1080730. eCollection 2023.
PubMed 36873989
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model to Early Predict the Response of Belimumab Treatment in the Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04893161
- Acronym / sponsor ID
- MRBS / XJTU1AF2020LSK-278
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 19 May 2021 (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.
A prospective, single-center cohort study aims to determine a predictive model of the response of belimumab at Week 48.
Detailed description
Preamble:
Belimumab is an inhibitor of B cell activating factor (BAFF) that has been developed as an agent for the treatment of patients with systemic lupus erythematosus (SLE).
In July 2019, belimumab was approved for marketing in China. The belimumab treatment has been proved to reduce the level of autoantibodies and control disease activity in the patients with SLE. The response rate of SLE Responder Index-4 (SRI-4) is approximately 50% in the BLISS-52 and BLISS-76 phase III clinical trials. The goal of this study is to establish a predictive model (including immune marker, inflammatory biomarker and clinical factor) to early estimate the response of belimumab treatment.
Objectives:
Primary objective: in the patients with SLE, an early predictive model of the response of belimumab treatment will be estimated.
Secondary objectives:
In subjects with SLE receiving belimumab treatment, to assess the effect of belimumab on:
The clinical improvement; The serological variables improvemen. The inflammatory biomarkers improvemen. The quality of life. The dosage of prednisone. The kinetics of B cell phenotype. The function of non-switched memory B cells. The association between the immune, inflammatory and clinical markers and the response of belimumab.
The mechanism of BAFF inhibition on the survival and selection of SLE non-switched memory B cells.
The recovering of immune checkpoint in non-switched memory B cells from the view of BCR mutation.
The rates of adverse events.
Overview of study design:
This is a prospective, single-center cohort study to estimate a predictive model of the response of belimumab. All patients with SLE receive belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48. All patients are evaluated at week 0, 2, 4, 8, 12, 24, 36, and 48. The immune markers, inflammatory biomarkers, clinical markers and safety data are assessed following belimumab treatment.
Study population:
Men or women with SLE who have active (according to SLEDAI-2K) and refractory SLE manifestations. SLE manifestations are defined as refractory in case of drug intolerance, unresponsiveness, or disease relapse in patients treated with corticosteroids, antimalarials, and/or immunosuppressants. Patients with renal disease were considered as refractory when they had a persistence of 24 hours proteinuria > 1 g after at least 1 year from the start of the initial therapy or when they experienced a renal flare (24 hours proteinuria > 1 g in case of previous complete response or doubling 24 hours proteinuria in other cases) during the subsequent therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients with SLE will be enrolled in one year and administrated belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48.
| Arm | Type | Receives |
|---|---|---|
| belimumab | Other | Drug: BelimumabAll patients with SLE receive belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48. The patients who had SRI-4 response at week 48 were divided into response group and the patients without SRI-4 response at week 48 were divided into no response group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fulfillment of the 1997 American College of Rheumatology (ACR) revised criteria for SLE;
- Aged more than 18 years;
- Active (according to SLEDAI-2K) and refractory SLE manifestations. SLE manifestations are defined as refractory in case of drug intolerance, unresponsiveness, or disease relapse in patients treated with corticosteroids, antimalarials, and/or immunosuppressants. Patients with renal disease were considered as refractory when they had a persistence of 24 hours proteinuria > 1 g after at least 1 year from the start of the initial therapy or when they experienced a renal flare (24 hours proteinuria > 1 g in case of previous complete response or doubling 24 hours proteinuria in other cases) during the subsequent therapy.
Key exclusion criteria (16 listed)
- Have a history of malignant neoplasm within the last 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years;
- Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, poses a significant suicide risk;
- Have a history of a primary immunodeficiency;
- Have a significant IgG deficiency (IgG level < 400 mg/dL);
- Have an IgA deficiency (IgA level < 10 mg/dL)
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 |
|---|---|---|
| BelimumabAlso: The standard careAll patients with SLE will be enrolled in one year and administrated belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48. | Drug | belimumab |
Primary outcome
Establishment of predictive model to assess the SRI response rate.
Time frame: at week 48
An SRI response is defined as a ≥ 4-point reduction in SELENA-SLEDAI score, no new BILAG A organ domain score and no more than 1 new BILAG B score, and no worsening (increase < 0.3) in PGA score versus baseline.
2 secondary outcomes
The SRI-4 response rate
Time frame: at week 48
The rate of adverse events
Time frame: week 0 to week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 36873989Wang J, Ju B, Zhu L, Li H, Luo J, Zhang J, Hu N, Mo L, Wang Y, Pan Y, Huang J, Lv X, Pu D, Hao Z, He L, Li Y. The rapid inhibition of B-cell activation markers by belimumab was associated with disease control in systemic lupus erythematosus patients. Front Pharmacol. 2023 Feb 16;14:1080730. doi: 10.3389/fphar.2023.1080730. eCollection 2023.
- 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.
Lan He, Dr. study chair
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belimumab in people with Systemic Lupus Erythematosus, run by First Affiliated Hospital Xi'an Jiaotong University.
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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang, Dr. (0086-18092691661, kidip@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of predictive model to assess the SRI response rate. (time frame: at week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893161, which also lists 1 linked publication.
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 21 Sep 2023.