Last updated: 07/17/2024 15:21:25
A Continuation Trial for Subjects with Lupus that Completed Protocol HGS1006-C1056 or HGS1006-C1057
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects with Systemic Lupus Erythematosus (SLE) who completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057
Trial description: This is a long-term continuation study to provide continuing treatment to subjects with SLE.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with Adverse events (AE)
Timeframe: Up to 9 years
AE rates by System Organ Class (SOC) During the Study
Timeframe: Up to 9 years
Number of participants with Serious Adverse events (SAE)
Timeframe: Up to 9 years
SAE rates by SOC During the Study
Timeframe: Up to 9 years
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Hematocrit at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Calcium (Ca), Carbon dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Blood urea nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in BUN and Glucose at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Timeframe: Baseline and up to 9 years
Change from Baseline in alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) levels
Timeframe: Baseline and up to 9 years
Change from Baseline in bilirubin (bili) levels
Timeframe: Baseline and up to 9 years
Change from Baseline in immunoglobulin G (IgG) levels
Timeframe: Baseline and up to 9 years
Number of participants with immunogenic response by year
Timeframe: Up to 9 years
Number of participants with IgG values below the lower limit of normal by year
Timeframe: Up to 9 years
Number of participants with shifts from Baseline in Prednisone and other steroids dose by visit
Timeframe: Up to 9 years
Number of participants with any SLICC/ ACR Damage Index worsening (change > 0) from Baseline by visit
Timeframe: Up to 9 years
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
738
Primary completion date:
2016-09-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bruce I, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D .Long-term Organ Damage Accrual and Safety in Patients with SLE Treated with Belimumab Plus Standard of Care.Lupus .2016;25(7):699-709.
Ronald F Van Vollenhoven, Sandra V Navarra, Roger A Levy, Mathew Thomas, Amy Heath, Todd Lustine, Anthony Adamkovic, James Fettiplace, Mei-Lun Wang, Beulah Ji, and David Roth.Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.Rheumatology (Oxford).2019
Ronald F Van Vollenhoven, Sandra V Navarra, Roger A Levy, Mathew Thomas, Amy Heath, Todd Lustine, Anthony Adamkovic, James Fettiplace, Mei-Lun Wang, Beulah Ji, and David Roth.Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.Rheumatology (Oxford).2020;59(2):281-291
DOI: http://dx.doi.org/10.1093/rheumatology/kez279
PMID: 31302695
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GSK
Study date(s)
May 2008 to December 2016
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.
- Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.
Inclusion and exclusion criteria
Inclusion criteria:
- Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.
Exclusion criteria:
- Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.
Trial location(s)
Location
GSK Investigational Site
Brno - Bohunice, Czech Republic, 625 00
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1280AEB
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1015
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1417EYG
Status
Study Complete
Location
GSK Investigational Site
Dalin Township, Chiayi county, Taiwan, 662
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Gueishan Township,Taoyuan County, Taiwan, 333
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Hradec Králové, Czech Republic, 500 05
Status
Study Complete
Location
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
Status
Study Complete
Location
GSK Investigational Site
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, B1904CFH,
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Status
Study Complete
Location
GSK Investigational Site
Ponce, Puerto Rico, Puerto Rico, 00716
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 22411-001
Status
Study Complete
Location
GSK Investigational Site
San Luis Potosí, San Luis Potosí, Mexico, 78240
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Tucumán, Argentina, T4000AXL
Status
Study Complete
Location
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 04039-901
Status
Study Complete
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04032-060
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04266-010
Status
Study Complete
Location
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 2570017
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2016-09-12
Actual study completion date
2016-09-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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