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BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

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ClinicalTrials.gov Identifier: NCT01597622
Recruitment Status : Completed
First Posted : May 14, 2012
Results First Posted : January 9, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Belimumab Phase 3

Detailed Description:
This is a multicentre, continuation study of belimumab plus standard of care (SOC) in SLE subjects who completed the Phase III BEL113750 protocol in Northeast Asia or who completed the open-label extension of the HGS1006-C1115 protocol in Japan. This study provides subjects who complete the BEL113750 study the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their SOC SLE therapy. Subjects participating in this continuation protocol will continue to be monitored for safety and efficacy, as measured by the SLE responder index. Subjects who complete 48 weeks of treatment on the BEL113750 study and who meet inclusion/exclusion criteria, and provide informed consent, will be given the option to enter the continuation study. All subjects will receive belimumab 10 mg/kg IV infused over 1 hour every 4 weeks. Subjects recruited into this study will continue to receive treatment with belimumab until such time as belimumab becomes commercially available in a subject's country of participation, or the subject elects to participate in another belimumab continuation study for SLE, or until either the subject's physician withdraws the subject from the study, or upon the decision by the sponsor to discontinue further development of belimumab for SLE.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BEL114333, a Multicenter, Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in Japan
Actual Study Start Date : June 11, 2012
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Arm Intervention/treatment
Experimental: Open-label Belimumab
Belimumab 10 mg/kg administered intravenously every 4 weeks. All study subjects will receive standard SLE therapies during the study. Subjects will continue to receive belimumab treatment until such time belimumab becomes commercially available in a subject's country of participation, or the subject elects to participate in another belimumab continuation study for SLE, or until either the subject's physician withdraws the subject from the study, or upon the decision by the sponsor to discontinue further development of belimumab for SLE.
Drug: Belimumab
10 mg/kg administered intravenously over 1 hour every 4 weeks




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Up to 6 calendar years and 9 months ]
    Any untoward medical occurrence in participant, temporally associated with use of medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death,life threatening,requires hospitalization or prolongation of existing hospitalization,results in disability/incapacity,congenital anomaly/birth defect,medically important were categorized as SAE. Number of participants who had any AE(includes those having non-serious and/or serious AEs) or any SAE are presented.Treatment-emergent AEs are defined as AEs that started on or after first dose of belimumab treatment and for those participants who were randomized to placebo in parent study,ongoing AEs that started before first open-label belimumab dose(in either C1115 open-label extension or BEL114333),worsened (severity,seriousness,relatedness) at any point during the open-label treatment.Timeframe includes exposure in parent study/upto16 weeks post infusion in current study(114333).


Secondary Outcome Measures :
  1. Percentage of SLE Responder Index (SRI) Responders by Study Visit [ Time Frame: Study Years 1 to 7: At Week 24 and 48 Visits, Year 8: only Week 24 Visit ]
    SRI response is composite index, defined as percent of participants with>=4 point reduction from Baseline in safety of estrogen in lupus national assessment systemic lupus erythematosus disease activity index (SELENA-SLEDAI) score and no worsening (increase of <0.30 points from Baseline) in physicians global assessment(PGA) &no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0(no activity) to 3(severe activity). BILAG has no range. Baseline is last available value prior to first belimumab exposure. Year 8 Week 24 visit is the Exit Visit obtained by slotting the Exit Visit to Week 24. Timeframe includes exposure in parent study/upto 4 weeks post infusion (Exit visit) in current study (114333).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed the BEL113750 Protocol in Northeast Asia through Week 48 OR have completed the open-label extension of C1115 in Japan.
  • Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in BEL113750 OR be able to receive the first dose of IV belimumab 1 week (plus a 1 week visit window) after the last dose of open-label SC belimumab in C1115..

Exclusion Criteria:

  • Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.
  • Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study.

Information from the National Library of Medicine

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): NCT01597622


Locations
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Japan
GSK Investigational Site
Chiba, Japan, 275-8580
GSK Investigational Site
Ehime, Japan, 791-0295
GSK Investigational Site
Fukuoka, Japan, 807-8555
GSK Investigational Site
Fukuoka, Japan, 810-8563
GSK Investigational Site
Hiroshima, Japan, 730-8619
GSK Investigational Site
Hiroshima, Japan, 739-0002
GSK Investigational Site
Hokkaido, Japan, 060-8604
GSK Investigational Site
Hokkaido, Japan, 060-8648
GSK Investigational Site
Hyogo, Japan, 675-8545
GSK Investigational Site
Miyagi, Japan, 980-8574
GSK Investigational Site
Nagasaki, Japan, 857-1195
GSK Investigational Site
Okayama, Japan, 710-8522
GSK Investigational Site
Okinawa, Japan, 901-0243
GSK Investigational Site
Tochigi, Japan, 321-0293
GSK Investigational Site
Tokyo, Japan, 104-8560
GSK Investigational Site
Tokyo, Japan, 113-8431
GSK Investigational Site
Tokyo, Japan, 160-8582
GSK Investigational Site
Tokyo, Japan, 162-8655
Korea, Republic of
GSK Investigational Site
Busan, Korea, Republic of, 602-715
GSK Investigational Site
Busan, Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 700-721
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 133-792
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of, 150-713
GSK Investigational Site
Suwon, Kyonggi-do, Korea, Republic of, 443-721
Sponsors and Collaborators
GlaxoSmithKline
Human Genome Sciences Inc.
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Statistical Analysis Plan  [PDF] May 31, 2019
Study Protocol  [PDF] May 16, 2014

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01597622    
Other Study ID Numbers: 114333
First Posted: May 14, 2012    Key Record Dates
Results First Posted: January 9, 2020
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=20307
Keywords provided by GlaxoSmithKline:
SELENA
belimumab
Lupus
systemic lupus erythematosus
PGA
BLys
SLE Flare Index
continuation
phase III
BILAG
extension
efficacy
SRI
B cell
SLEDAI
safety
Asia
B lymphocyte
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs