Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

NCT05644210 | Unknown

• 1 other identifier: Bioagents in APS QiluH
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Antiphospholipid Syndrome

Keywords

Telitacicept; Rituximab

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (10)

• The proportion of patients who achieved response(complete response and partial response) in aPL profiles

  Week 24,48

• The change of aPL titer

  week 12 , 24,48

• The changes of the positive number of 7 aPL indicators

  week 12, 24,48

• The change of clinical efficacy in subgroups with different symptoms

  Before the screening,baseline and week 12,24,48

• The change of aGAPSS score

  Before the screening,baseline and week 12,24,48

Other Outcomes (1)

• The number of participants experiencing adverse events

  Before the screening,baseline and week 4,12,24,48

Study Arms (2)

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

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

Drug: Rituximab; Drug: Aspirin; Drug: Warfarin; Drug: Hydroxychloroquine; Drug: Prednisone

Interventions

Telitacicept DRUG

160mg once a week for 24 weeks

Also known as: TA

RTX+TA group

Rituximab DRUG

Patients received 200mg of rituximab intravenously at week 0 and week 2.

Also known as: RTX

RTX group; RTX+TA group

Aspirin DRUG

50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response

Also known as: Asp

RTX group; RTX+TA group

Warfarin DRUG

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 known as: WF

RTX group; RTX+TA group

Hydroxychloroquine DRUG

200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period

Also known as: HCQ

RTX group; RTX+TA group

Prednisone DRUG

5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response

Also known as: Pred

RTX group; RTX+TA group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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;

You may qualify if:

• Patients who meet 2006 Sapporo classification criteria of APS or 2020 nonstandard APS performance；
• Patients who meet 1997 or 2019 SLE classification criteria ;
• Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart;
• 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;
• Maintain a stable base treatment regimen for at least 4 weeks before screening; Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine;
• No response, intolerance or dependence on glucocorticoids and immunosuppressants;
• Patients who had previously used beliumab or Telitacicept could be enrolled in the study after 12 weeks of discontinuation;
• Age ≥18 years;
• Signed Informed consent.

You may not qualify if:

• 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;
• A history of allergy to the relevant test drug;
• Patients had recently received a live vaccine or planned to use any live vaccine during the study;
• Ongoing pregnancy;
• Patients who were participants in clinical trials of other immunosuppressive agents/biologics within 24 weeks;
• Other conditions that the investigator considers would make the candidate unsuitable for the study;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, Shandong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood, saliva and stool

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

telitacicept; Rituximab; Aspirin; Agouti Signaling Protein; Warfarin; Hydroxychloroquine; Prednisone; prednylidene

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chloroquine; Aminoquinolines; Quinolines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yang Xiaoyun, Dr.

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Shu Qiang, Dr.

CONTACT

0086-0531-82169654; shuqiang@sdu.edu.cn

Zhang Xiaoyu

CONTACT

0086-0531-82169654; 1146978430@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 9, 2022
• Study Start: October 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 9, 2022

Record last verified: 2022-11

Locations

CN (1)