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The purpose of this study was to explore the clinical and immunological efficacy of Telitacicept and low dose IL-2 on systemic lupus erythematosus.
Given that Telitacicept and low dose IL2 have been widespreadly applied in the treatment of systemic lupus erythematosus, this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of Telitacicept and low dose IL-2. 160mg Telitacicept and 1 million IU IL2 were regularly administered according to different circumstances. Then, the investigators evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telitacicept and low dose IL2 | Experimental | 160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks. Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL2 was injected once a week for 12 weeks subcutaneously. |
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| Telitacicept | Active Comparator | 160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks. |
|
| low dose IL2 | Active Comparator | Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL2 was injected once a week for 12 weeks subcutaneously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Drug | 160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of SLE Responder Index (SRI)4 response | The number of participants who achieved SRI4 response at week 24. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | The number of participants with Adverse Events throughout the study were accessed. | Week 24 |
| Autoantibody change from baseline | Blood samples were collected at indicated time-points for analysis of autoantibodies like anti-double stranded deoxyribonucleic Acid(dsDNA). Baseline is defined as the Day 0 visit from parent studies. |
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Inclusion Criteria:
Male or female >18 years of age at screening visits
Patients meet the American-European Consensus Group 2002 classification criteria of SLE.
The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:
Exclusion Criteria:
Any subject meeting any of the following criteria should be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Liu, Dr | Contact | +8613661345637 | mikle317@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li | Peking University Institute of Rheuamotology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
| C035529 | RC-18 |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Interleukin-2 | Drug | Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks. |
|
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| Week 12 and 24 |
| Change of complement C3 and C4 Levels from baseline | Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. | Week 12 and 24 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |