Clinical trial NCT00712933: A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Belimumab
Antibodies
Systemic Lupus Erythematosus
Lupus
Autoimmune Diseases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-07-10
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Detailed description: This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AE)
timeFrame: Up to 9 years
measure: AE Rates by System Organ Class (SOC) During the Study
timeFrame: Up to 9 years
measure: Number of Participants With Serious Adverse Events (SAE)
timeFrame: Up to 9 years
measure: SAE Rates by SOC During the Study
timeFrame: Up to 9 years
measure: 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
measure: 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
measure: Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
timeFrame: Baseline and up to 9 years
measure: Change From Baseline in Hematocrit at the Indicated Time Points
timeFrame: Baseline and up to 9 years
measure: Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
timeFrame: Baseline and up to 9 years
measure: 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
measure: Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
timeFrame: Baseline and up to 9 years
measure: Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
timeFrame: Baseline and up to 9 years
measure: Change From Baseline in BUN and Glucose at the Indicated Time Points
timeFrame: Baseline and up to 9 years
measure: Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
timeFrame: Baseline and up to 9 years
measure: 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
measure: Change From Baseline in Bilirubin (Bili) Levels
timeFrame: Baseline and up to 9 years
measure: Change From Baseline in Immunoglobulin G (IgG) Levels
timeFrame: Baseline and up to 9 years
measure: Number of Participants With Immunogenic Response by Year
timeFrame: Up to 9 years
measure: Number of Participants With IgG Values Below the Lower Limit of Normal by Year
timeFrame: Up to 9 years
measure: Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
timeFrame: Up to 9 years
measure: Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
timeFrame: Up to 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Salvador
country: Brazil
facility: GSK Investigational Site
state: Bahía
city: Goiania
country: Brazil
facility: GSK Investigational Site
state: Goiás
city: Juiz de Fora
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Recife
country: Brazil
facility: GSK Investigational Site
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Campinas
country: Brazil
facility: GSK Investigational Site
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Bucaramanga
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Brno - Bohunice
country: Czechia
facility: GSK Investigational Site
city: Hradec Králové
country: Czechia
facility: GSK Investigational Site
city: Olomouc
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Suresnes
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Kiel
country: Germany
facility: GSK Investigational Site
city: Chai Wan
country: Hong Kong
facility: GSK Investigational Site
city: New Territories
country: Hong Kong
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Hyderabad, Andhra Pradesh
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: Secunderabad
country: India
facility: GSK Investigational Site
city: Trivandrum
country: India
facility: GSK Investigational Site
city: Beer Sheva
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Petach Tikva
country: Israel
facility: GSK Investigational Site
city: Ramat-Gan
country: Israel
facility: GSK Investigational Site
city: Rehovot
country: Israel
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon, Kyonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: San Luis Potosí
country: Mexico
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Surco
country: Peru
facility: GSK Investigational Site
state: Lima
city: Callao
country: Peru
facility: GSK Investigational Site
city: Lima 27
country: Peru
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Davao City
country: Philippines
facility: GSK Investigational Site
city: Las Pinas
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Sampaloc Manila
country: Philippines
facility: GSK Investigational Site
city: Konskie
country: Poland
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucuresti
country: Romania
facility: GSK Investigational Site
city: Bucuresti
country: Romania
facility: GSK Investigational Site
city: Cluj Napoca
country: Romania
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Piestany
country: Slovakia
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Dalin Township, Chiayi County
country: Taiwan
facility: GSK Investigational Site
city: Gueishan Township,Taoyuan County
country: Taiwan
facility: GSK Investigational Site
city: Hualien
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bruce IN, 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 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.
citation: van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
citation: Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1):e000412. doi: 10.1136/lupus-2020-000412.