Antiphospholipid SyndromeNCT05644210
Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE
An observational study of Antiphospholipid Syndrome, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The aim of this study was to observe the clinical efficacy and safety of rituximab (RTX) combination with telitacicept (TA) in patients of systemic lupus erythematosus secondary antiphospholipid syndrome (APS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antiphospholipid Syndrome
- What is being tested?
- Telitacicept, Rituximab and Aspirin
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Meet the diagnostic criteria of SLE and related symptoms of secondary APS; 2. Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart; 3. One or more of the following related clinical symptoms: 1. Refractory/recurrent thrombocytopenia; 2. Autoimmune hemolytic anemia; 3. Heart valve disease; 4. Renal involvement; 5. Skin ulcer; 6. arterial or deep vein thrombosis;
Who may be able to join
- 1.Patients who meet 2006 Sapporo classification criteria of APS or 2020 nonstandard APS performance；
- 2.Patients who meet 1997 or 2019 SLE classification criteria ;
- 3.Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart;
- 4.with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, nephropathy, valve heart disease ,skin ulcer and arterial or deep vein thrombosis;
- 5.Maintain a stable base treatment regimen for at least 4 weeks before screening; Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine;
- 6.No response, intolerance or dependence on glucocorticoids and immunosuppressants;
Show all 9Show fewer
- 7.Patients who had previously used beliumab or Telitacicept could be enrolled in the study after 12 weeks of discontinuation;
- 8.Age ≥18 years;
- 9.Signed Informed consent.
Who cannot join
- 1.Patients with other causes of thrombocytopenia, hemolytic anemia, valvular heart disease, kidney disease and skin ulcer symptoms were excluded, such as drugs, infections, blood system diseases, genetic metabolic diseases, etc;
- 2.Severe cardiovascular diseases, kidney, liver and other important organ injuries, serious blood and endocrine system lesions (aplastic anemia, hyperthyroidism crisis, etc.) were excluded; A history of active malignancy (within 5 years) was excluded and chemoradiotherapy was performed; Patients with organ or bone marrow transplantation in the past year were excluded. Exclusion of mentally ill persons;
- 3.A history of allergy to the relevant test drug;
- 4.Patients had recently received a live vaccine or planned to use any live vaccine during the study;
- 5.Ongoing pregnancy;
- 6.Patients who were participants in clinical trials of other immunosuppressive agents/biologics within 24 weeks;
- 7.Other conditions that the investigator considers would make the candidate unsuitable for the study;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital
Jinan, Shandong, Shandong
Xiaoyun Yang, 0086-0531-82169166, qlyykyc@163.com
About this study
Official title: The Clinical Efficacy and Safety of Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE ，a Multicentre Observational Study
The aim of this study was to observe the clinical efficacy and safety of rituximab (RTX) combination with telitacicept (TA) in patients of systemic lupus erythematosus secondary antiphospholipid syndrome (APS).
Read the detailed description
In this multicenter, prospective, observational study, 80 patients with SLE Secondary APS patients were enrolled. RTX alone or its continuation with TA was observed for 24weeks，and extended for another 24 weeks. At week 12, the RTX group could be converted to the combination group. The primary end point was the response rate of total antiphospholipid antibody (aPL) at week 12. The secondary end points included the decline rate and value of aPL antibody, aGAPSS score, remission degree of specific clinical indicators, changes in SLE disease activity in SAPS group, and drug safety at week 12 and week 24.
- Conditions
- Antiphospholipid Syndrome
- Being tested
- Telitacicept, Rituximab, Aspirin, Warfarin, Hydroxychloroquine
- Keywords
- Telitacicept, Rituximab
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Also called TA
160mg once a week for 24 weeks
RituximabDrug
Also called RTX
Patients received 200mg of rituximab intravenously at week 0 and week 2.
AspirinDrug
Also called Asp
50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
WarfarinDrug
Also called WF
Warfarin should be used in patients with arterial thrombosis, and rivaroxaban should be replaced if the patient cannot reach the standard or cannot tolerate it
Also called HCQ
200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period
PrednisoneDrug
Also called Pred
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
| Study group | Role | What they receive |
|---|---|---|
| RTX+TA group | Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin Receives: Drug: Telitacicept; Drug: Rituximab; Drug: Aspirin; Drug: Warfarin; Drug: Hydroxychloroquine; Drug: Prednisone | |
| RTX group | Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period Basic treatment：Hydroxychloroquine、Prednisone、Warfarin、Aspirin Receives: Drug: Rituximab; Drug: Aspirin; Drug: Warfarin; Drug: Hydroxychloroquine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieved response(complete response and partial response) in aPL profiles
For the lupus anticoagulant (LAC) test, we defined complete response (CR) as a negative test result and no response(NR) as a positive test result； For the anticardiolipin antibody (aCL)/anti-β2 glycoprotein I (anti-β2GPI)enzyme-linked immunosorbent assay,CR was defined as a titer of<the 95th percentile, partial response (PR) was defined as a titer of 95th -99th , and NR was defined as a titer of >the 99th percentile.
Measured: Week 12
Secondary outcomes (10)
The proportion of patients who achieved response(complete response and partial response) in aPL profiles
For the lupus anticoagulant (LAC) test, we defined complete response (CR) as a negative test result and no response(NR) as a positive test result； For the anticardiolipin antibody (aCL)/anti-β2 glycoprotein I (anti-β2GPI)enzyme-linked immunosorbent assay,CR was defined as a titer of<the 95th percentile, partial response (PR) was defined as a titer of 95th -99th , and NR was defined as a titer of >the 99th percentile.
Measured: Week 24,48
The change of aPL titer
titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody
Measured: week 12 , 24,48
The changes of the positive number of 7 aPL indicators
Change in the number of antibody positives.
Measured: week 12, 24,48
The change of clinical efficacy in subgroups with different symptoms
Thrombocytopenia, haemolytic anemia, nephropathy, heart valve lesions, skin changes (livedo reticularis, leg ulcers)
Measured: Before the screening,baseline and week 12,24,48
The change of aGAPSS score
The aGAPSS was calculated by adding the points corresponding to the risk factors: three for hyperlipidemia, one for arterial hypertension, five for positive anticardiolipin antibodies, four for positive anti-β2 glycoprotein-I antibodies and four for positive lupus anticoagulant test.
Measured: Before the screening,baseline and week 12,24,48
The change of Damage Index for Antiphospholipid Syndrome (DIAPS)
The score is obtained by adding the output rating for each domain. The instrument demonstrated content, criterion, and construct validity being a precise tool to quantify organ damage in APS.
Measured: Before the screening and week 12,24,48
The change of Physician Global Assessment (PGA) score .
PGA is a physician-reported visual analogue scale that provides an overall meas- ure of the subject's current disease activity,the PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity;
Measured: Before the screening,baseline and week 12,24,48
The change of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k) Score
The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE patients in the previous 10 days.
Measured: Before the screening,baseline and week 12,24,48
The percentage of patients with Lupus Low Disease Activity State (LLDAS)
LLDAS is defined as: (1) SLE Disease Activity Index (SLEDAI)-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no haemolytic anaemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) ≤1; (4) a current prednisolone (or equivalent) dose ≤7.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.
Measured: Before the screening,baseline and week 12,24,48
Glucocorticoid (GC) dose and reduction rate
The proportion of patients who received the GC dose at each time point
Measured: Before the screening,baseline and week 4,12,24,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Shu, Qilu Hospital of Shandong University
- Investigators
- Yang Xiaoyun, Dr., Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644210
- Sponsor's protocol ID
- Bioagents in APS QiluH
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 9 Dec 2022
- 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 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy and Safety of Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE ，a Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT05644210
- Acronym / sponsor ID
- Bioagents in APS QiluH
- Conditions
- Antiphospholipid Syndrome
- Keywords
- Telitacicept, Rituximab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Dec 2022 (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.
The aim of this study was to observe the clinical efficacy and safety of rituximab (RTX) combination with telitacicept (TA) in patients of systemic lupus erythematosus secondary antiphospholipid syndrome (APS).
Detailed description
In this multicenter, prospective, observational study, 80 patients with SLE Secondary APS patients were enrolled. RTX alone or its continuation with TA was observed for 24weeks，and extended for another 24 weeks. At week 12, the RTX group could be converted to the combination group. The primary end point was the response rate of total antiphospholipid antibody (aPL) at week 12. The secondary end points included the decline rate and value of aPL antibody, aGAPSS score, remission degree of specific clinical indicators, changes in SLE disease activity in SAPS group, and drug safety at week 12 and week 24.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTX+TA group | – | Drug: Telitacicept, Drug: Rituximab, Drug: Aspirin, Drug: Warfarin, Drug: Hydroxychloroquine, Drug: PrednisoneScreening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2. Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin |
| RTX group | – | Drug: Rituximab, Drug: Aspirin, Drug: Warfarin, Drug: Hydroxychloroquine, Drug: PrednisoneScreening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2. Follow-up period Basic treatment：Hydroxychloroquine、Prednisone、Warfarin、Aspirin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Meet the diagnostic criteria of SLE and related symptoms of secondary APS; 2. Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart; 3. One or more of the following related clinical symptoms: 1. Refractory/recurrent thrombocytopenia; 2. Autoimmune hemolytic anemia; 3. Heart valve disease; 4. Renal involvement; 5. Skin ulcer; 6. arterial or deep vein thrombosis;
Key inclusion criteria (9 listed)
- 1.Patients who meet 2006 Sapporo classification criteria of APS or 2020 nonstandard APS performance；
- 2.Patients who meet 1997 or 2019 SLE classification criteria ;
- 3.Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart;
- 4.with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, nephropathy, valve heart disease ,skin ulcer and arterial or deep vein thrombosis;
- 5.Maintain a stable base treatment regimen for at least 4 weeks before screening; Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine;
Key exclusion criteria (7 listed)
- 1.Patients with other causes of thrombocytopenia, hemolytic anemia, valvular heart disease, kidney disease and skin ulcer symptoms were excluded, such as drugs, infections, blood system diseases, genetic metabolic diseases, etc;
- 2.Severe cardiovascular diseases, kidney, liver and other important organ injuries, serious blood and endocrine system lesions (aplastic anemia, hyperthyroidism crisis, etc.) were excluded; A history of active malignancy (within 5 years) was excluded and chemoradiotherapy was performed; Patients with organ or bone marrow transplantation in the past year were excluded. Exclusion of mentally ill persons;
- 3.A history of allergy to the relevant test drug;
- 4.Patients had recently received a live vaccine or planned to use any live vaccine during the study;
- 5.Ongoing pregnancy;
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 |
|---|---|---|
| TelitaciceptAlso: TA160mg once a week for 24 weeks | Drug | RTX+TA group |
| RituximabAlso: RTXPatients received 200mg of rituximab intravenously at week 0 and week 2. | Drug | RTX group, RTX+TA group |
| AspirinAlso: Asp50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response | Drug | RTX group, RTX+TA group |
| WarfarinAlso: WFWarfarin should be used in patients with arterial thrombosis, and rivaroxaban should be replaced if the patient cannot reach the standard or cannot tolerate it | Drug | RTX group, RTX+TA group |
| HydroxychloroquineAlso: HCQ200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period | Drug | RTX group, RTX+TA group |
| PrednisoneAlso: Pred5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response | Drug | RTX group, RTX+TA group |
Primary outcome
The proportion of patients who achieved response(complete response and partial response) in aPL profiles
Time frame: Week 12
For the lupus anticoagulant (LAC) test, we defined complete response (CR) as a negative test result and no response(NR) as a positive test result； For the anticardiolipin antibody (aCL)/anti-β2 glycoprotein I (anti-β2GPI)enzyme-linked immunosorbent assay,CR was defined as a titer of<the 95th percentile, partial response (PR) was defined as a titer of 95th -99th , and NR was defined as a titer of >the 99th percentile.
10 secondary outcomes
The proportion of patients who achieved response(complete response and partial response) in aPL profiles
Time frame: Week 24,48
The change of aPL titer
Time frame: week 12 , 24,48
The changes of the positive number of 7 aPL indicators
Time frame: week 12, 24,48
The change of clinical efficacy in subgroups with different symptoms
Time frame: Before the screening,baseline and week 12,24,48
The change of aGAPSS score
Time frame: Before the screening,baseline and week 12,24,48
The change of Damage Index for Antiphospholipid Syndrome (DIAPS)
Time frame: Before the screening and week 12,24,48
The change of Physician Global Assessment (PGA) score .
Time frame: Before the screening,baseline and week 12,24,48
The change of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k) Score
Time frame: Before the screening,baseline and week 12,24,48
The percentage of patients with Lupus Low Disease Activity State (LLDAS)
Time frame: Before the screening,baseline and week 12,24,48
Glucocorticoid (GC) dose and reduction rate
Time frame: Before the screening,baseline and week 4,12,24,48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
Related trials for Antiphospholipid Syndrome
Recruiting
Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study
Antiphospholipid Syndrome
RecruitingObservational study
Follow-up Cohort of Patients With Antiphospholipid Syndrome
Antiphospholipid Syndrome (APS)
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Systemic Lupus Erythematosus, Systemic Sclerosis
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
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.
Yang Xiaoyun, Dr. study director
Qilu Hospital of Shandong University
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 Antiphospholipid Syndrome, run by Qilu Hospital of Shandong University 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 9 inclusion and 7 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 9 Dec 2022. 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 Shu Qiang, Dr. (0086-0531-82169654, shuqiang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who achieved response(complete response and partial response) in aPL profiles (time frame: Week 12). 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 9 Dec 2022.