Phase 3
Completed N=677
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
Source: ClinicalTrials.gov NCT01345253 ↗Enrolled (actual)
677
Serious AEs
17.5%
Results posted
Dec 2016
Primary outcomePrimary: Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase. — 40.1; 53.8 Percentage of participants — p=0.0001
◆ Published Evidence
Established
41citations · ~21 / year
Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials.
Summary
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.
Linked Publications (5)
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Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials.
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Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials.
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Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials.
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Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo-controlled trial in North East Asia.
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Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase. |
40.1; 53.8 | 0.0001 sig |
| SECONDARY Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase. |
42.2; 55.7 | 0.0001 sig |
| SECONDARY Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase. |
23.5; 32.4 | 0.0116 sig |
| SECONDARY Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase. |
0.0; 0.0 | 0.0288 sig |
| SECONDARY Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase. |
NA; NA | 0.0004 sig |
| SECONDARY Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase |
66.0; 69.6; 72.3; 70.9; 71.7; 76.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years and older.
- Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
- Have active SLE disease.
- Have positive anti-nuclear antibody (ANA) test results.
- Are on a stable SLE treatment regimen.
- Females of childbearing age are willing to use appropriate contraception
Exclusion Criteria
- Have received treatment with any B cell targeted therapy at any time.
- Have received a biologic investigational agent in the past year.
- Have received 3 or more courses of systemic corticosteroids in the past year.
- Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0.
- Have severe lupus kidney disease.
- Have active central nervous system (CNS) lupus.
- Have had a major organ transplant.
- Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
- Have a planned surgical procedure.
- Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix.
- Have required management of acute or chronic infections in the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.
- Have an IgA deficiency.
- Have severe laboratory Abnormalities.
- Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
- Suicidal behavior or ideation.
Data sourced from ClinicalTrials.gov (NCT01345253) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.