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

Study Description

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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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	420 participants
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
Estimated Primary Completion Date :	September 28, 2018
Estimated Study Completion Date :	September 28, 2018

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Adverse Events [ Time Frame: Up to 5 years ]
   To evaluate the long-term safety of belimumab in subjects with SLE in Northeast Asia

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01597622 History of Changes
Other Study ID Numbers:	114333
First Posted:	May 14, 2012
Last Update Posted:	March 23, 2018
Last Verified:	March 2018

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