Systemic Lupus ErythematosusNCT06458972
Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)
An observational study of Systemic Lupus Erythematosus, run by Tongji Hospital at 1 site in China.
Trial summary
Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease involving multiple systems caused by abnormal immune activation. It is a classic diffuse connective tissue disease characterized by autoimmune inflammation. Our study population is the people who confirmed diagnosis of systemic lupus erythematosus (SLE) by 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) International classification diagnostic criteria and patients receiving Tacrolimus injections.
Who may be able to join
- Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
- Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;
- Accepting the treatment of telitacicept.
Who cannot join
- Subjects who meet any of the following criteria should be excluded from this study:
- Patients with other rheumatic immune system diseases;
- Patients in the active stage of acute and chronic infections;
- Patients using other biologics;
- Patients with wasting diseases such as malignant tumors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 43003
Dong Lingli, MD, +862783665519, tjhdongll@163.com
Cai Shaozhe, MD, 15623423810, 540361903@qq.com
About this study
Official title: Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study
Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. B cells are the core of systemic lupus erythematosus (SLE) pathogenesis. B Lymphocyte Stimulator (BLyS, also called BAFF) and A Proliferation-Inducing Ligand (APRIL) are signals for B cell maturation. B Lymphocyte Stimulator (BLyS) participates in promoting the development and maturation of B cells, while A Proliferation-Inducing Ligand (APRIL) participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells. Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand (CAML) Interactor (TACI) and the Fragment crystallizable (Fc) segment of human Immunoglobulin G1 (IgG1). It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (SLE) , blocking B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL), hindering the development and activation of B cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of B cells at different stages. In this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (SLE) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (SLE) patients.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Telitacicept, adherence, safety, effectiveness
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI）
Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI） is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with SLE. It is scored by a table named "SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) INSTRUMENT SCORE" . The minimum and maximum values are 0 points and 105 points separately, but very few patients score higher than 45 points. Higher scores indicate higher disease activity.
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Physician's Global Assessment
Physician's global assessment for patients with Systemic Lupus Erythematosus (SLE) is a subjective assessment tool used by a same physicians to evaluate the overall disease activity based on clinical observations and patient reports(the patient's symptoms, physical examination findings, laboratory results, and any other relevant clinical information). The physician's global assessment (PGA) scale typically ranges from 0 to 3, with 0 representing no disease activity and 3 representing severe disease activity. Some variations of the scale may include intermediate markers, such as 1 and 2, to indicate varying degrees of disease activity.
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a questionnaire-based tool (FACIT-F, Vision 4) used to measure fatigue in patients. It consists of multiple items, each focusing on a different aspect of fatigue. The items are typically rated on a scale from 0 to 4, with 0 representing "not at all" and 4 representing "very much". Example items include: "I feel tired" or "I'm too tired to working". Higher scores indicate less fatigue.
Measured: Baseline and Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Serum anti-double stranded DNA (anti-dsDNA)
to describe the qualitative feature of systemic lupus erythematosus (SLE) patients' serum anti-double stranded DNA (anti-dsDNA).
Measured: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C3 levels
Serum complement C3 levels (g/L)
Measured: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C4 levels
Serum complement C4 levels (g/L)
Measured: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum immunoglobulin quantification
Serum immunoglobulin quantification (g/L)
Measured: Baseline, Month 6, Month 12 after injecting Telitacecipt
Levels of C-reactive protein (CRP) levels
Levels of C-reactive protein (CRP) levels (mg/L)
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of interleukin-10 (IL-10) levels
Levels of interleukin-10 (IL-10) levels (pg/mL)
Measured: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of ferritin levels
Levels of ferritin levels (ug/L)
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
the safety of telitacicept for SLE patients
The probability of adverse reactions （Local adverse reactions after injection） and the probability of major drug-related adverse events
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
the reasons for medication discontinuation
The investigators will survey the reasons for medication discontinuation by telephone or outpatient follow-up ,the different reasons include economic reasons、 disease improved or be a stable condition、 poor effect、 arise adverse reaction, etc.
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of leukocyte levels
Levels of leukocyte levels （*10^9/L）
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of hemoglobin (Hb) levels
Levels of hemoglobin (Hb) levels (g/L)
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of blood platelet (PLT) levels
Levels of blood platelet (PLT) levels (*10^9/L)
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
routine urine test
To evaluate the grade of urine occult blood and urine protein
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of erythrocyte sedimentation rate (ESR) levels
Levels of erythrocyte sedimentation rate (ESR) levels (mm/h）
Measured: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of interleukin-6 (IL-6) levels
Levels of interleukin-6 (IL-6) levels (pg/mL)
Measured: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-4 (IL-4) levels
Levels of interleukin-4 (IL-4) levels (pg/mL)
Measured: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-2 (IL-2) levels
Levels of interleukin-2 (IL-2) levels (pg/mL)
Measured: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of tumor necrosis factor-α (TNF-α) levels
Levels of tumor necrosis factor-α (TNF-α) levels (pg/mL)
Measured: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interferon-γ（IFN-γ） levels
Levels of interferon-γ（IFN-γ） levels (pg/mL)
Measured: Baseline and Month 6，Month 12 after injecting Telitacecipt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jan 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jingzhou Central Hospital, Wuhan Central Hospital, Xiangyang Central Hospital, Wuhan No.1 Hospital, China Three Gorges University, Yichang, China, Shanghai Zhongshan Hospital, The First People's Hospital of Jingzhou
- Responsible party
- Principal investigator, Lingli Dong, Tongji Hospital
- Investigators
- Dong Lingli, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458972
- Sponsor's protocol ID
- TJ-IRB20231298
- Status last verified
- Sep 2024
- First submitted
- 31 May 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06458972
- Acronym / sponsor ID
- TJ-IRB20231298
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Telitacicept, adherence, safety, effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Jingzhou Central Hospital, Wuhan Central Hospital, Xiangyang Central Hospital, Wuhan No.1 Hospital, China Three Gorges University, Yichang, China, Shanghai Zhongshan Hospital, The First People's Hospital of Jingzhou
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. B cells are the core of systemic lupus erythematosus (SLE) pathogenesis. B Lymphocyte Stimulator (BLyS, also called BAFF) and A Proliferation-Inducing Ligand (APRIL) are signals for B cell maturation. B Lymphocyte Stimulator (BLyS) participates in promoting the development and maturation of B cells, while A Proliferation-Inducing Ligand (APRIL) participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells. Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand (CAML) Interactor (TACI) and the Fragment crystallizable (Fc) segment of human Immunoglobulin G1 (IgG1). It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (SLE) , blocking B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL), hindering the development and activation of B cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of B cells at different stages. In this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (SLE) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (SLE) patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease involving multiple systems caused by abnormal immune activation. It is a classic diffuse connective tissue disease characterized by autoimmune inflammation. Our study population is the people who confirmed diagnosis of systemic lupus erythematosus (SLE) by 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) International classification diagnostic criteria and patients receiving Tacrolimus injections.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
- Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;
- Accepting the treatment of telitacicept.
Key exclusion criteria (5 listed)
- Patients with other rheumatic immune system diseases;
- Patients in the active stage of acute and chronic infections;
- Patients using other biologics;
- Patients with wasting diseases such as malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI）
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI） is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with SLE. It is scored by a table named "SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) INSTRUMENT SCORE" . The minimum and maximum values are 0 points and 105 points separately, but very few patients score higher than 45 points. Higher scores indicate higher disease activity.
Physician's Global Assessment
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Physician's global assessment for patients with Systemic Lupus Erythematosus (SLE) is a subjective assessment tool used by a same physicians to evaluate the overall disease activity based on clinical observations and patient reports(the patient's symptoms, physical examination findings, laboratory results, and any other relevant clinical information). The physician's global assessment (PGA) scale typically ranges from 0 to 3, with 0 representing no disease activity and 3 representing severe disease activity. Some variations of the scale may include intermediate markers, such as 1 and 2, to indicate varying degrees of disease activity.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Baseline and Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a questionnaire-based tool (FACIT-F, Vision 4) used to measure fatigue in patients. It consists of multiple items, each focusing on a different aspect of fatigue. The items are typically rated on a scale from 0 to 4, with 0 representing "not at all" and 4 representing "very much". Example items include: "I feel tired" or "I'm too tired to working". Higher scores indicate less fatigue.
Serum anti-double stranded DNA (anti-dsDNA)
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
to describe the qualitative feature of systemic lupus erythematosus (SLE) patients' serum anti-double stranded DNA (anti-dsDNA).
Serum complement C3 levels
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C3 levels (g/L)
Serum complement C4 levels
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C4 levels (g/L)
Serum immunoglobulin quantification
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum immunoglobulin quantification (g/L)
Levels of C-reactive protein (CRP) levels
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of C-reactive protein (CRP) levels (mg/L)
Levels of interleukin-10 (IL-10) levels
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-10 (IL-10) levels (pg/mL)
Levels of ferritin levels
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of ferritin levels (ug/L)
the safety of telitacicept for SLE patients
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
The probability of adverse reactions （Local adverse reactions after injection） and the probability of major drug-related adverse events
the reasons for medication discontinuation
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
The investigators will survey the reasons for medication discontinuation by telephone or outpatient follow-up ,the different reasons include economic reasons、 disease improved or be a stable condition、 poor effect、 arise adverse reaction, etc.
Levels of leukocyte levels
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of leukocyte levels （*10^9/L）
Levels of hemoglobin (Hb) levels
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of hemoglobin (Hb) levels (g/L)
Levels of blood platelet (PLT) levels
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of blood platelet (PLT) levels (*10^9/L)
routine urine test
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
To evaluate the grade of urine occult blood and urine protein
Levels of erythrocyte sedimentation rate (ESR) levels
Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of erythrocyte sedimentation rate (ESR) levels (mm/h）
Levels of interleukin-6 (IL-6) levels
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-6 (IL-6) levels (pg/mL)
Levels of interleukin-4 (IL-4) levels
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-4 (IL-4) levels (pg/mL)
Levels of interleukin-2 (IL-2) levels
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-2 (IL-2) levels (pg/mL)
Levels of tumor necrosis factor-α (TNF-α) levels
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of tumor necrosis factor-α (TNF-α) levels (pg/mL)
Levels of interferon-γ（IFN-γ） levels
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interferon-γ（IFN-γ） levels (pg/mL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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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.
Dong Lingli, MD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Tongji Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 19 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Lingli, MD (17742804229, tjhdongll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI） (time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt). The study lists 22 primary outcomes in all. 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 19 Nov 2024.