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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01597622
First received: May 10, 2012
Last updated: July 7, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Systemic Lupus Erythematosus
Drug: Belimumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    To evaluate the long-term safety of belimumab in subjects with SLE in Northeast Asia


Estimated Enrollment: 420
Study Start Date: June 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597622

Locations
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, 710-0824
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
GSK Investigational Site
Suwon, Kyonggi-do, Korea, Republic of, 443-721
Sponsors and Collaborators
GlaxoSmithKline
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01597622     History of Changes
Other Study ID Numbers: 114333 
Study First Received: May 10, 2012
Last Updated: July 7, 2016
Health Authority: Japan: Pharmaceutical and Medical Device Agency

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:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016