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
Last Update Posted : October 9, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: Belimumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 143 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 |
Actual Primary Completion Date : | September 13, 2018 |
Actual Study Completion Date : | September 13, 2018 |

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.
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Drug: Belimumab
10 mg/kg administered intravenously over 1 hour every 4 weeks |
- Adverse Events [ Time Frame: Up to 5 years ]To evaluate the long-term safety of belimumab in subjects with SLE in Northeast Asia

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

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
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, 150-713 | |
GSK Investigational Site | |
Suwon, Kyonggi-do, Korea, Republic of, 443-721 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01597622 History of Changes |
Other Study ID Numbers: |
114333 |
First Posted: | May 14, 2012 Key Record Dates |
Last Update Posted: | October 9, 2018 |
Last Verified: | October 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 |