Systemic Lupus ErythematosusPhase 4NCT05666336
Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients
A Phase 4 study testing Telitacicept, Hydroxychloroquine and Prednisone in people with Systemic Lupus Erythematosus, run by Fen Li at 1 site in China.
Trial summary
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Telitacicept, Hydroxychloroquine and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2022to 30 Jun 2024
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria 1997 and clinically active disease.
- Patients with good compliance, will sign the informed consent before the test.
- Patients who have received conventional treatment for SLE, and the type and dose of treatment drugs have been stable for at least 30 days.
- Patients who have a positive anti-nuclear antibody test result and SELENA-SLEDAI score ≥8 at screening. If there is a low complement and/or positive anti-dsDNA antibody, the SELENA-SLEDAI score can be defined as ≥ 6 points.
Who cannot join
- Patients with severe lupus nephritis, defined as urinary protein > 6g /24 hours or serum creatinine > 221μmol/L within the last 2 months, or who require hemodialysis.
- Patients with SLE-caused or non-SLE-caused central nervous system disease within the last 2 months.
- Patients with severe condition in blood, important organs including heart, liver, gastrointestinal tract and endocrine system which are not related with SLE.
- Patients who use prednisone ≥100mg/d over 14 days or receive plasma replacement and suffer from active infection within the last 1 month.
- Patients who received any other targeted agents over the past 12 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Xiangya Second Hospital, Central South University
Changsha, Hunan, 410000
Huiyu Nie, 18113519492, niehuiyu2022@163.com
About this study
Official title: Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. The investigators hope to screen predictive biomarkers of efficacy and explore the mechanism of difference in efficacy of Telitacicept with Chinese characteristics by omics.
Read the detailed description
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Due to the poor therapeutic efficacy and prominent adverse reactions after long-term use of glucocorticoid combined immunosuppressants, the development of targeted drug use for SLE has become a hot area of research for several years. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. As another important part of targeted drug use, the research on biomarkers predictive of drug response is also in full swing in the treatment of SLE. The omics technology has unique advantages in screening biomarkers and exploring the mechanism of drug action. The integrated analysis of multi omics can mutually verify and supplement the screening results of a single omics, so as to more systematically and comprehensively analyze the biological molecular functions and regulatory mechanisms. Therefore, this topic selects serum proteomics combined with metabolomics to screen biomarkers for the prediction of the efficacy of Telitacicept, and to explore the mechanism of the difference in the efficacy of Telitacicept, with a view to providing meaningful reference for the exploration of SLE precise treatment.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Telitacicept, Hydroxychloroquine, Prednisone, Methylprednisolone, Cyclophosphamide
- Keywords
- Systemic Lupus Erythematosus, Telitacicept, efficiency, omics
- 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.
TelitaciceptBiological
Also called RC18
It is necessary and will be given by subcutaneous injection of 160mg/week for 24 weeks.
Also called HCQ
It is necessary and will be given by oral administration of 0.2g/day for 24 weeks.
PrednisoneDrug
Also called PRED
It is permitted which can be interchangeable with methylprednisolone. It will be given by oral administration of 30mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
Also called MP
It is permitted which can be interchangeable with prednisone. It will be given by oral administration of 24mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
CyclophosphamideDrug
Also called CTX
It is permitted which can be interchangeable with mycophenolate mofetil or tacrolimus. It will be given by oral administration of 0.8g/month for 24 weeks.
Also called MMF
It is permitted which can be interchangeable with cyclophosphamide or tacrolimus. It will be given by oral administration of 0.5g twice a day for 24 weeks.
TacrolimusDrug
Also called TAC
It is permitted which can be interchangeable with cyclophosphamide or mycophenolate mofetil. It will be given by oral administration of 1mg twice a day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The treatment regimen consists of four drugs, a glucocorticoid plus Telitacicept plus hydroxychloroquine plus an immunosuppressor.
Prednisone(30mg, Qd) or Methylprednisolone(24mg, Qd) plus Telitacicept(160mg, Qw) plus Hydroxychloroquine (0.2g, Qd) plus cyclophosphamide(0.8g, Qm) or Mycophenolate Mofetil (0.5g, Bid) or Tacrolimus (1mg, Bid) The above treatment will continue for 24 weeks. Receives: Biological: Telitacicept; Drug: Hydroxychloroquine; Drug: Prednisone; Drug: Methylprednisolone; Drug: Cyclophosphamide; Drug: Mycophenolate Mofetil; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE Responder Index (SRI) 4 response rate
(1) Definition of SRI4: ≥4 point reduction from baseline in SELENA-SLEDAI score, no worsening (<0.3 point increase from baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or two new BILAG B organ domain scores vs baseline. (2) The patients acquired SRI4 were classified as Good Responders (GR), The patients not acquired SRI4 were classified as Non-Responders (NR).
Measured: week 24
Secondary outcomes (4)
The changes of glucocorticoids dose
The percentage of patients whose average prednisone dose was ≤7.5 mg/day or reduced by ≥25% from baseline.
Measured: week 24
The variation of serum markers
The variation of serum markers including BLyS,APRIL,CD19+B lymphocytes count, anti-dsDNA antibodies, IgG, IgA, IgM, complement3(C3), and complement4(C4) at baseline and after 24 weeks' treatment.
Measured: week 24
Proteomics
Screening and comparison of different proteins
Measured: week 24
Metabonomics
Screening and comparison of different metabolites
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start31 Dec 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fen Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fen Li, Central South University
- Investigators
- Fen Li, doctor, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666336
- Sponsor's protocol ID
- LYF2022151
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.
PubMed 34463932Fan Y, Gao D, Zhang Z. Telitacicept, a novel humanized, recombinant TACI-Fc fusion protein, for the treatment of systemic lupus erythematosus. Drugs Today (Barc). 2022 Jan;58(1):23-32. doi: 10.1358/dot.2022.58.1.3352743.
PubMed 35107091Hruskova Z, Tesar V. Lessons learned from the failure of several recent trials with biologic treatment in systemic lupus erythematosus. Expert Opin Biol Ther. 2018 Sep;18(9):989-996. doi: 10.1080/14712598.2018.1504918. Epub 2018 Jul 31.
PubMed 30040494Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233.
PubMed 20039413Vital EM, Dass S, Buch MH, Henshaw K, Pease CT, Martin MF, Ponchel F, Rawstron AC, Emery P. B cell biomarkers of rituximab responses in systemic lupus erythematosus. Arthritis Rheum. 2011 Oct;63(10):3038-47. doi: 10.1002/art.30466.
PubMed 21618204Pirone C, Mendoza-Pinto C, van der Windt DA, Parker B, O Sullivan M, Bruce IN. Predictive and prognostic factors influencing outcomes of rituximab therapy in systemic lupus erythematosus (SLE): A systematic review. Semin Arthritis Rheum. 2017 Dec;47(3):384-396. doi: 10.1016/j.semarthrit.2017.04.010. Epub 2017 May 5.
PubMed 28602359Cecchi I, Perez-Sanchez C, Sciascia S, Radin M, Arias de la Rosa I, Barbarroja Puerto N, Scudeler L, Perez-Sanchez L, Patino Trives AM, Aguirre Zamorano MA, Menegatti E, Roccatello D, Lopez-Pedrera C. Circulating microRNAs as potential biomarkers for monitoring the response to in vivo treatment with Rituximab in systemic lupus erythematosus patients. Autoimmun Rev. 2020 Apr;19(4):102488. doi: 10.1016/j.autrev.2020.102488. Epub 2020 Feb 13. No abstract available.
PubMed 32062026Davies JC, Midgley A, Carlsson E, Donohue S, Bruce IN, Beresford MW, Hedrich CM. Urine and serum S100A8/A9 and S100A12 associate with active lupus nephritis and may predict response to rituximab treatment. RMD Open. 2020 Jul;6(2):e001257. doi: 10.1136/rmdopen-2020-001257.
PubMed 32723832Davies JC, Carlsson E, Midgley A, Smith EMD, Bruce IN, Beresford MW, Hedrich CM; BILAG-BR and MRC MASTERPLANS Consortia. A panel of urinary proteins predicts active lupus nephritis and response to rituximab treatment. Rheumatology (Oxford). 2021 Aug 2;60(8):3747-3759. doi: 10.1093/rheumatology/keaa851.
PubMed 33313921Iaccarino L, Andreoli L, Bocci EB, Bortoluzzi A, Ceccarelli F, Conti F, De Angelis R, De Marchi G, De Vita S, Di Matteo A, Emmi G, Emmi L, Gatto M, Gerli R, Gerosa M, Govoni M, Larosa M, Meroni PL, Mosca M, Pazzola G, Reggia R, Saccon F, Salvarani C, Tani C, Zen M, Frigo AC, Tincani A, Doria A. Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Results of a large, multicentric, nationwide study. J Autoimmun. 2018 Jan;86:1-8. doi: 10.1016/j.jaut.2017.09.004. Epub 2017 Sep 19.
PubMed 28935492Piantoni S, Regola F, Masneri S, Merletti M, Lowin T, Airo P, Tincani A, Franceschini F, Andreoli L, Pongratz G. Characterization of B- and T-Cell Compartment and B-Cell Related Factors Belonging to the TNF/TNFR Superfamily in Patients With Clinically Active Systemic Lupus Erythematosus: Baseline BAFF Serum Levels Are the Strongest Predictor of Response to Belimumab after Twelve Months of Therapy. Front Pharmacol. 2021 May 21;12:666971. doi: 10.3389/fphar.2021.666971. eCollection 2021.
PubMed 34093196Yao X, Ren Y, Zhao Q, Chen X, Jiang J, Liu D, Hu P. Pharmacokinetics analysis based on target-mediated drug distribution for RC18, a novel BLyS/APRIL fusion protein to treat systemic lupus erythematosus and rheumatoid arthritis. Eur J Pharm Sci. 2021 Apr 1;159:105704. doi: 10.1016/j.ejps.2021.105704. Epub 2021 Jan 10.
PubMed 33440243Gordon C, Wofsy D, Wax S, Li Y, Pena Rossi C, Isenberg D. Post Hoc Analysis of the Phase II/III APRIL-SLE Study: Association Between Response to Atacicept and Serum Biomarkers Including BLyS and APRIL. Arthritis Rheumatol. 2017 Jan;69(1):122-130. doi: 10.1002/art.39809. Epub 2016 Dec 2.
PubMed 27390168Merrill JT, Wallace DJ, Wax S, Kao A, Fraser PA, Chang P, Isenberg D; ADDRESS II Investigators. Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study. Arthritis Rheumatol. 2018 Feb;70(2):266-276. doi: 10.1002/art.40360.
PubMed 29073347Stohl W, Hilbert DM. The discovery and development of belimumab: the anti-BLyS-lupus connection. Nat Biotechnol. 2012 Jan 9;30(1):69-77. doi: 10.1038/nbt.2076.
PubMed 22231104
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05666336
- Acronym / sponsor ID
- LYF2022151
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Telitacicept, efficiency, omics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fen LiUniversity, hospital or other
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 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.
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. The investigators hope to screen predictive biomarkers of efficacy and explore the mechanism of difference in efficacy of Telitacicept with Chinese characteristics by omics.
Detailed description
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Due to the poor therapeutic efficacy and prominent adverse reactions after long-term use of glucocorticoid combined immunosuppressants, the development of targeted drug use for SLE has become a hot area of research for several years. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. As another important part of targeted drug use, the research on biomarkers predictive of drug response is also in full swing in the treatment of SLE. The omics technology has unique advantages in screening biomarkers and exploring the mechanism of drug action. The integrated analysis of multi omics can mutually verify and supplement the screening results of a single omics, so as to more systematically and comprehensively analyze the biological molecular functions and regulatory mechanisms. Therefore, this topic selects serum proteomics combined with metabolomics to screen biomarkers for the prediction of the efficacy of Telitacicept, and to explore the mechanism of the difference in the efficacy of Telitacicept, with a view to providing meaningful reference for the exploration of SLE precise treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Telitacicept, Drug: Hydroxychloroquine, Drug: Prednisone, Drug: Methylprednisolone, Drug: Cyclophosphamide, Drug: Mycophenolate Mofetil, Drug: TacrolimusThe treatment regimen consists of four drugs, a glucocorticoid plus Telitacicept plus hydroxychloroquine plus an immunosuppressor. Prednisone(30mg, Qd) or Methylprednisolone(24mg, Qd) plus Telitacicept(160mg, Qw) plus Hydroxychloroquine (0.2g, Qd) plus cyclophosphamide(0.8g, Qm) or Mycophenolate Mofetil (0.5g, Bid) or Tacrolimus (1mg, Bid) The above treatment will continue for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria 1997 and clinically active disease.
- Patients with good compliance, will sign the informed consent before the test.
- Patients who have received conventional treatment for SLE, and the type and dose of treatment drugs have been stable for at least 30 days.
- Patients who have a positive anti-nuclear antibody test result and SELENA-SLEDAI score ≥8 at screening. If there is a low complement and/or positive anti-dsDNA antibody, the SELENA-SLEDAI score can be defined as ≥ 6 points.
Key exclusion criteria (5 listed)
- Patients with severe lupus nephritis, defined as urinary protein > 6g /24 hours or serum creatinine > 221μmol/L within the last 2 months, or who require hemodialysis.
- Patients with SLE-caused or non-SLE-caused central nervous system disease within the last 2 months.
- Patients with severe condition in blood, important organs including heart, liver, gastrointestinal tract and endocrine system which are not related with SLE.
- Patients who use prednisone ≥100mg/d over 14 days or receive plasma replacement and suffer from active infection within the last 1 month.
- Patients who received any other targeted agents over the past 12 months.
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: RC18It is necessary and will be given by subcutaneous injection of 160mg/week for 24 weeks. | Biological | Experimental Group |
| HydroxychloroquineAlso: HCQIt is necessary and will be given by oral administration of 0.2g/day for 24 weeks. | Drug | Experimental Group |
| PrednisoneAlso: PREDIt is permitted which can be interchangeable with methylprednisolone. It will be given by oral administration of 30mg/day from beginning and be lowed dosage during the treatment of 24 weeks. | Drug | Experimental Group |
| MethylprednisoloneAlso: MPIt is permitted which can be interchangeable with prednisone. It will be given by oral administration of 24mg/day from beginning and be lowed dosage during the treatment of 24 weeks. | Drug | Experimental Group |
| CyclophosphamideAlso: CTXIt is permitted which can be interchangeable with mycophenolate mofetil or tacrolimus. It will be given by oral administration of 0.8g/month for 24 weeks. | Drug | Experimental Group |
| Mycophenolate MofetilAlso: MMFIt is permitted which can be interchangeable with cyclophosphamide or tacrolimus. It will be given by oral administration of 0.5g twice a day for 24 weeks. | Drug | Experimental Group |
| TacrolimusAlso: TACIt is permitted which can be interchangeable with cyclophosphamide or mycophenolate mofetil. It will be given by oral administration of 1mg twice a day for 24 weeks. | Drug | Experimental Group |
Primary outcome
SLE Responder Index (SRI) 4 response rate
Time frame: week 24
(1) Definition of SRI4: ≥4 point reduction from baseline in SELENA-SLEDAI score, no worsening (<0.3 point increase from baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or two new BILAG B organ domain scores vs baseline. (2) The patients acquired SRI4 were classified as Good Responders (GR), The patients not acquired SRI4 were classified as Non-Responders (NR).
4 secondary outcomes
The changes of glucocorticoids dose
Time frame: week 24
The variation of serum markers
Time frame: week 24
Proteomics
Time frame: week 24
Metabonomics
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 34463932Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.
- Background: PubMed 35107091Fan Y, Gao D, Zhang Z. Telitacicept, a novel humanized, recombinant TACI-Fc fusion protein, for the treatment of systemic lupus erythematosus. Drugs Today (Barc). 2022 Jan;58(1):23-32. doi: 10.1358/dot.2022.58.1.3352743.
- Background: PubMed 30040494Hruskova Z, Tesar V. Lessons learned from the failure of several recent trials with biologic treatment in systemic lupus erythematosus. Expert Opin Biol Ther. 2018 Sep;18(9):989-996. doi: 10.1080/14712598.2018.1504918. Epub 2018 Jul 31.
- Background: PubMed 20039413Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233.
- Background: PubMed 21618204Vital EM, Dass S, Buch MH, Henshaw K, Pease CT, Martin MF, Ponchel F, Rawstron AC, Emery P. B cell biomarkers of rituximab responses in systemic lupus erythematosus. Arthritis Rheum. 2011 Oct;63(10):3038-47. doi: 10.1002/art.30466.
- Background: PubMed 28602359Pirone C, Mendoza-Pinto C, van der Windt DA, Parker B, O Sullivan M, Bruce IN. Predictive and prognostic factors influencing outcomes of rituximab therapy in systemic lupus erythematosus (SLE): A systematic review. Semin Arthritis Rheum. 2017 Dec;47(3):384-396. doi: 10.1016/j.semarthrit.2017.04.010. Epub 2017 May 5.
- Background: PubMed 32062026Cecchi I, Perez-Sanchez C, Sciascia S, Radin M, Arias de la Rosa I, Barbarroja Puerto N, Scudeler L, Perez-Sanchez L, Patino Trives AM, Aguirre Zamorano MA, Menegatti E, Roccatello D, Lopez-Pedrera C. Circulating microRNAs as potential biomarkers for monitoring the response to in vivo treatment with Rituximab in systemic lupus erythematosus patients. Autoimmun Rev. 2020 Apr;19(4):102488. doi: 10.1016/j.autrev.2020.102488. Epub 2020 Feb 13. No abstract available.
- Background: PubMed 32723832Davies JC, Midgley A, Carlsson E, Donohue S, Bruce IN, Beresford MW, Hedrich CM. Urine and serum S100A8/A9 and S100A12 associate with active lupus nephritis and may predict response to rituximab treatment. RMD Open. 2020 Jul;6(2):e001257. doi: 10.1136/rmdopen-2020-001257.
- Background: PubMed 33313921Davies JC, Carlsson E, Midgley A, Smith EMD, Bruce IN, Beresford MW, Hedrich CM; BILAG-BR and MRC MASTERPLANS Consortia. A panel of urinary proteins predicts active lupus nephritis and response to rituximab treatment. Rheumatology (Oxford). 2021 Aug 2;60(8):3747-3759. doi: 10.1093/rheumatology/keaa851.
- Background: PubMed 28935492Iaccarino L, Andreoli L, Bocci EB, Bortoluzzi A, Ceccarelli F, Conti F, De Angelis R, De Marchi G, De Vita S, Di Matteo A, Emmi G, Emmi L, Gatto M, Gerli R, Gerosa M, Govoni M, Larosa M, Meroni PL, Mosca M, Pazzola G, Reggia R, Saccon F, Salvarani C, Tani C, Zen M, Frigo AC, Tincani A, Doria A. Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Results of a large, multicentric, nationwide study. J Autoimmun. 2018 Jan;86:1-8. doi: 10.1016/j.jaut.2017.09.004. Epub 2017 Sep 19.
- Background: PubMed 34093196Piantoni S, Regola F, Masneri S, Merletti M, Lowin T, Airo P, Tincani A, Franceschini F, Andreoli L, Pongratz G. Characterization of B- and T-Cell Compartment and B-Cell Related Factors Belonging to the TNF/TNFR Superfamily in Patients With Clinically Active Systemic Lupus Erythematosus: Baseline BAFF Serum Levels Are the Strongest Predictor of Response to Belimumab after Twelve Months of Therapy. Front Pharmacol. 2021 May 21;12:666971. doi: 10.3389/fphar.2021.666971. eCollection 2021.
- Background: PubMed 33440243Yao X, Ren Y, Zhao Q, Chen X, Jiang J, Liu D, Hu P. Pharmacokinetics analysis based on target-mediated drug distribution for RC18, a novel BLyS/APRIL fusion protein to treat systemic lupus erythematosus and rheumatoid arthritis. Eur J Pharm Sci. 2021 Apr 1;159:105704. doi: 10.1016/j.ejps.2021.105704. Epub 2021 Jan 10.
- 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.
Fen Li, doctor principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telitacicept, Hydroxychloroquine and Prednisone in people with Systemic Lupus Erythematosus, run by Fen Li 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 4 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 17 Jan 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.
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 Fen Li, doctor (0086-731-85295255, lifen0731@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE Responder Index (SRI) 4 response rate (time frame: week 24). 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 NCT05666336, which also lists 26 linked publications.
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 17 Jan 2024.