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Clinical Trials BETA
Clinical trials referenced in this document:
nct01649765 at ClinicalTrials.govnct00657007 at ClinicalTrials.govDocuments that mention this clinical trial
P128 Efficacy of intravenous belimumab in children with systemic lupus erythematosus with markers of high disease activity: across-trial comparison with adult belimumab studies
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FRI0181 THE PLUTO STUDY: INTRAVENOUS BELIMUMAB IN CHILDREN WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2019-EULAR.4884
THU0503 PLUTO TRIAL: SENSITIVITY ANALYSES OF SRI4 RESPONSE WITH BELIMUMAB VS PLACEBO IN PAEDIATRIC PATIENTS WITH CHILDHOOD-ONSET SYSTEMIC LUPUS ERYTHEMATOSUS (CSLE)
https://doi.org/10.1136/ANNRHEUMDIS-2020-EULAR.4441
Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial (Results)
https://doi.org/10.1136/ANNRHEUMDIS-2020-217101
SAT0505 PLUTO TRIAL OF INTRAVENOUS BELIMUMAB IN PAEDIATRIC PATIENTS WITH CHILDHOOD-ONSET SYSTEMIC LUPUS ERYTHEMATOSUS (cSLE): PATIENT RESPONSES OVER TIME
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Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/RMDOPEN-2021-001747
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/S40268-021-00363-2
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https://doi.org/10.1136/ANNRHEUMDIS-2018-213198
nct00071487 at ClinicalTrials.govDocuments that mention this clinical trial
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
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Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/S40268-021-00369-W
nct01345253 at ClinicalTrials.govDocuments that mention this clinical trial
Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/RMDOPEN-2021-001747
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/S40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/S40268-021-00369-W
OP0232 Sustained safety and efficacy over 10 years with belimumab (BEL) plus standard systemic lupus erythematosus (SLE) therapy (SOC) in patients with SLE
https://doi.org/10.1136/ANNRHEUMDIS-2017-EULAR.6430
nct01516450 at ClinicalTrials.govDocuments that mention this clinical trial
Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/RMDOPEN-2021-001747
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https://doi.org/10.1007/S40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/S40268-021-00369-W
Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea
https://doi.org/10.1136/RMDOPEN-2021-001629
A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea
https://doi.org/10.1136/ANNRHEUMDIS-2017-211631
nct00410384 at ClinicalTrials.govDocuments that mention this clinical trial
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/S40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/S40268-021-00369-W
nct00424476 at ClinicalTrials.govDocuments that mention this clinical trial
FRI0205 ANTIMALARIAL AGENTS IMPROVE PHYSICAL FUNCTIONING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2019-EULAR.6430
P128 Efficacy of intravenous belimumab in children with systemic lupus erythematosus with markers of high disease activity: across-trial comparison with adult belimumab studies
https://doi.org/10.1136/LUPUS-2020-EUROLUPUS.172
Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme
https://doi.org/10.1136/LUPUS-2020-000459
Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
https://doi.org/10.1080/14712598.2019.1561856
POS0762 CAN THE SLE-DAS SUBSTITUTE BILAG TO MEASURE LUPUS DISEASE ACTIVITY IN CLINICAL TRIALS? POST-HOC ANALYSIS OF THE BLISS-76 TRIAL
https://doi.org/10.1136/ANNRHEUMDIS-2021-EULAR.3162
Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study
https://doi.org/10.1136/LUPUS-2020-000412
A Retrospective Administrative Claims Database Evaluation of the Utilization of Belimumab in US Managed Care Settings
https://doi.org/10.1016/J.CLINTHERA.2015.10.008
FRI0175 PREDICTORS OF LOW DISEASE ACTIVITY AND CLINICAL REMISSION FOLLOWING BELIMUMAB TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2019-EULAR.6376
OP0297 THE SLE-DAS ENABLES ACCURATE AND USER-FRIENDLY DEFINITIONS OF REMISSION AND CATEGORIES OF LUPUS DISEASE ACTIVITY: DERIVATION AND VALIDATION STUDY IN 1190 SLE PATIENTS
https://doi.org/10.1136/ANNRHEUMDIS-2021-EULAR.1677
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https://doi.org/10.1136/ANNRHEUMDIS-2018-214043
POS0101 ADVERSE HEALTH-RELATED QUALITY OF LIFE OUTCOME DESPITE ADEQUATE CLINICAL RESPONSE TO TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2021-EULAR.1472
FRI0168 ASSOCIATION OF OVERWEIGHT/OBESITY WITH IMPAIRED HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2020-EULAR.4016
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https://doi.org/10.1136/ANNRHEUMDIS-2021-220363
FRI0198 ANTIMALARIAL AGENTS DIMINISH WHILE METHOTREXATE, AZATHIOPRINE AND MYCOPHENOLIC ACID INCREASE BAFF LEVELS IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2019-EULAR.6414
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https://doi.org/10.1136/ANNRHEUMDIS-2018-214427
Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/RMDOPEN-2021-001747
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https://doi.org/10.1007/S40268-021-00363-2
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https://doi.org/10.1136/BMJOPEN-2019-032334
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https://doi.org/10.1007/S40268-021-00369-W
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https://doi.org/10.1136/ANNRHEUMDIS-2019-215650
Effect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus
https://doi.org/10.1136/ANNRHEUMDIS-2019-216367
148 Antimalarial agents and other immunosuppressants influence BAFF levels in opposite directions in patients with systemic lupus erythematosus
https://doi.org/10.1136/LUPUS-2019-LSM.148
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
https://doi.org/10.1136/ANNRHEUMDIS-2018-214880
nct02880852 at ClinicalTrials.govDocuments that mention this clinical trial
FRI0205 ANTIMALARIAL AGENTS IMPROVE PHYSICAL FUNCTIONING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2019-EULAR.6430
Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial
https://doi.org/10.1016/S0140-6736(10)61354-2
P128 Efficacy of intravenous belimumab in children with systemic lupus erythematosus with markers of high disease activity: across-trial comparison with adult belimumab studies
https://doi.org/10.1136/LUPUS-2020-EUROLUPUS.172
Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme
https://doi.org/10.1136/LUPUS-2020-000459
Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
https://doi.org/10.1080/14712598.2019.1561856
Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study
https://doi.org/10.1136/LUPUS-2020-000412
A Retrospective Administrative Claims Database Evaluation of the Utilization of Belimumab in US Managed Care Settings
https://doi.org/10.1016/J.CLINTHERA.2015.10.008
FRI0175 PREDICTORS OF LOW DISEASE ACTIVITY AND CLINICAL REMISSION FOLLOWING BELIMUMAB TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2019-EULAR.6376
Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis
https://doi.org/10.1136/ANNRHEUMDIS-2018-214043
POS0101 ADVERSE HEALTH-RELATED QUALITY OF LIFE OUTCOME DESPITE ADEQUATE CLINICAL RESPONSE TO TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2021-EULAR.1472
FRI0168 ASSOCIATION OF OVERWEIGHT/OBESITY WITH IMPAIRED HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2020-EULAR.4016
FRI0198 ANTIMALARIAL AGENTS DIMINISH WHILE METHOTREXATE, AZATHIOPRINE AND MYCOPHENOLIC ACID INCREASE BAFF LEVELS IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/ANNRHEUMDIS-2019-EULAR.6414
Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus
https://doi.org/10.1136/ANNRHEUMDIS-2018-214427
Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/RMDOPEN-2021-001747
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/S40268-021-00363-2
Clinical trial data sharing: here’s the challenge
https://doi.org/10.1136/BMJOPEN-2019-032334
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/S40268-021-00369-W
How to use the Lupus Low Disease Activity State (LLDAS) in clinical trials
https://doi.org/10.1136/ANNRHEUMDIS-2019-215650
Effect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus
https://doi.org/10.1136/ANNRHEUMDIS-2019-216367
148 Antimalarial agents and other immunosuppressants influence BAFF levels in opposite directions in patients with systemic lupus erythematosus
https://doi.org/10.1136/LUPUS-2019-LSM.148
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
https://doi.org/10.1136/ANNRHEUMDIS-2018-214880
nct01583530 at ClinicalTrials.govDocuments that mention this clinical trial
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/S40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/S40268-021-00369-W
Documents that mention this clinical trial
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/S40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/S40268-021-00369-W
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Funding
Funding for this research was provided by:
GSK
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Text and Data Mining valid from 2021-10-09
Version of Record valid from 2021-10-09
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Article History
Accepted: 7 September 2021
First Online: 9 October 2021
Declarations
:
: This study was funded by GSK, which contributed to the design, collection, analysis, and interpretation of the data; contributed to the decision to submit the paper for publication; and supported the authors in the development of the manuscript. Medical writing support was provided by Olga Conn, PhD, of Fishawack Indicia Ltd., UK, funded by GSK.
: XZ is an employee of GSK and holds stocks and shares in the company. T-IL and PM were employees of GSK and held stocks and shares in the company at the time of the study. MZ is an intern of GSK.
: Not required for the current study; all anonymized data were aggregated from the original studies.
: Not required for the current study; obtained for the original studies.
: All authors approved the content of the submitted manuscript for publication.
: GSK is committed to publicly disclosing the results of GSK-sponsored clinical research that evaluates GSK medicines and as such was involved in the decision to submit. Anonymized individual patient data and study documents can be requested for further research from ExternalRef removed.
: Available in the electronic supplementary material.
: XZ and PM contributed to the conception and design of the study. T-IL and MZ contributed to the data sorting and NONMEM dataset. MZ contributed to the model updating. All authors contributed to data analysis or interpretation.
