Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (PLUTO)
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|ClinicalTrials.gov Identifier: NCT01649765|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: belimumab 10mg/kg Other: placebo||Phase 2|
Access to an investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus|
|Actual Study Start Date :||September 7, 2012|
|Actual Primary Completion Date :||January 24, 2018|
|Estimated Study Completion Date :||February 16, 2028|
Experimental: Arm 1
belimumab 10mg/kg IV monthly
Drug: belimumab 10mg/kg
belimumab 10mg/kg IV monthly
Placebo Comparator: Arm 2
Normal Saline IV monthly
Normal Saline 250 ml
Other Name: Normal Saline
- SLE Response Index (SRI) [ Time Frame: Week 52 ]>/=4 point reduction from baseline in SELENA SLEDAI score, and No worsening (increase of < 0.30 points from baseline) in Physician's Global Assessment (PGA), and No new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
- Proportion of subjects meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE [ Time Frame: Week 52 ]Proportion of subjects meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement. a. At least 50% improvement in any 2 of 5 endpoints and no more than 1 of the remaining worsening by more than 30%. 1. Percent change in Parent's Global Assessment (ParentGA). 2. Percent change in Physician's Global Assessment (PGA). 3. Percent change in SELENA SLEDAI score. 4. Change in PedsQL physical functioning domain. 5. Percent change in 24 hour proteinuria.
- Proportion of subjects with a sustained SRI response [ Time Frame: Week 52 ]Proportion of subjects with a sustained SRI response (defined as having a response on the primary efficacy endpoints at Weeks 44, 48, and 52)
- Proportion of subjects with a sustained Parent Global Assessment response [ Time Frame: Week 52 ]Proportion of subjects with a sustained Parent Global Assessment response (defined as having >0.7 improvement at Weeks 44, 48, and 52 compared at baseline).
- Number and percent of subjects with Adverse Events (AEs) [ Time Frame: 52 weeks ]All adverse events, severity, study agent related events, AEs leading to permanent discontinuation of study agent.
- Number and percent of subjects with Serious Adverse Events (SAEs) [ Time Frame: 52 weeks ]All Serious Adverse Events, severity, study agent related events, SAEs leading to permanent discontinuation of study agent, SAEs resulting in death.
- Summary of Pharmacokinetics Profile (AUC, Cmax, Cmin) [ Time Frame: 52 weeks ]AUC, Cmax, Cmin compared to adult Pharmacokinetics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649765
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|