Clinical Trials List
2013-04-01 - 2022-12-05
Phase IV
Recruiting1
Terminated7
ICD-10M32.0
Drug-induced systemic lupus erythematosus
ICD-10M32.10
Systemic lupus erythematosus, organ or system involvement unspecified
ICD-10M32.11
Endocarditis in systemic lupus erythematosus
ICD-10M32.12
Pericarditis in systemic lupus erythematosus
ICD-10M32.13
Lung involvement in systemic lupus erythematosus
ICD-10M32.14
Glomerular disease in systemic lupus erythematosus
ICD-10M32.15
Tubulo-interstitial nephropathy in systemic lupus erythematosus
ICD-10M32.19
Other organ or system involvement in systemic lupus erythematosus
ICD-10M32.8
Other forms of systemic lupus erythematosus
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-9710.0
Systemic lupus erythematosus
A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, AutoantibodyPositive Systemic Lupus Erythematosus Receiving Belimumab
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Human Genome Sciences, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 郭宏輝 Division of Rheumatology
- Yao-Fan Fang Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林靖麒 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳忠仁 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林世昌 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 劉峰誠 風濕免疫科
- 朱士傑 風濕免疫科
- Tsung-Yun Hou 風濕免疫科
- 陳政宏 風濕免疫科
- 郭三元 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
15 Recruiting
Co-Principal Investigator
- KO-JEN LI Division of Rheumatology
- CHENG-HAN WU Division of Rheumatology
- PING-NING HSU Division of Rheumatology
- 余家利 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The table below describes the safety endpoints and measures collected in the study.
All-cause mortality
Serious Infections (including serious opportunistic infections and any event of TB or TB reactivation)
Non-serious opportunistic infections and other infections of interest (Appendix 2)
Malignancies (excluding NMSC)
Non-melanoma skin cancers
Psychiatric events suggesting serious mood disorders and anxiety
Suicidality (using C-SSRS; Appendix 4 and Appendix 5)
Serious Infusion and Hypersensitivity Reactions
All SAEs
The major efficacy endpoint is:
• Percent of subjects whose average prednisone (or equivalent) dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52 (in the subgroup of subjects receiving > 7.5 mg/day of prednisone (or equivalent) at baseline).
Inclution Criteria
2. Have a diagnosis of SLE, refer to ACR revised criteria for the classification of SLE
(Appendix 1) as a guide for diagnosis of SLE.
3. Active, autoantibody positive SLE (autoantibody positive is defined as the presence of
ANA or anti-dsDNA antibodies).
4. Are on a SLE treatment regimen consisting of any of the following medications (alone or in combination):
• Corticosteroids
• Other immunomodulatory agents including methotrexate, azathioprine, leflunomide,
mycophenolate (including mycophenolate mofetil, mycophenolate mofetil
hydrochloride, and mycophenolate sodium), calcineurin inhibitors (eg, tacrolimus,
cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide.
• Anti-malarials [eg, hydroxychloroquine, chloroquine, quinacrine (mepacrine)]
5. A female subject is eligible to enter the study if she is:
• Not pregnant or nursing;
• Of non-childbearing potential (ie, women who had a hysterectomy, are
postmenopausal which is defined as 1 year without menses, have both ovaries
surgically removed or have current documented tubal ligation or any other permanent
method of female sterilization); or
• Of childbearing potential (ie, women with functional ovaries and no documented
impairment of oviductal or uterine function that would cause sterility). This category
includes women with oligomenorrhoea [even severe], women who are perimenopausal
or have just begun to menstruate. These women must have a negative urine pregnancy
test at screening, and agree to 1 of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the
1st dose of study agent until 16 weeks after the last dose of study agent; or
- Consistent and correct use of 1 of the following acceptable methods of birth
control for 1 month prior to the start of the study agent, during the study and
16 weeks after the last dose of study agent:
◦ Implants of levonorgestrel or etonogestrel;
◦ Injectable progesterone;
◦ Any intrauterine device (IUD) with a documented failure rate of less than 1%
per year;
◦ Oral contraceptives (either combined or progesterone only);
◦ Ethinyl estradiol/Etonogestrel vaginal ring;
◦ Double barrier method: condom and occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/suppository;
◦ Transdermal contraceptive patch;
◦ Male partner who is sterile prior to the female subject’s entry into the study
and is the sole sexual partner for the female subject.
Note: MMF and other forms of mycophenolate affect the metabolism of oral
contraceptives and may reduce their effectiveness. As such, women receiving
mycophenolate who are using oral contraceptives for birth control should employ
an additional method (eg, barrier method).
6. Have the ability to understand the requirements of the study, provide written informed
consent, including consent for the use and disclosure of research-related health
information, and comply with the study data collection procedures.
Exclusion Criteria
2. Have received treatment with B cell targeted therapy (eg, rituximab, other anti-CD20
agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion
protein [BR3], TACI-Fc, anti-BAFF [LY2127399]) within 364 days of Day 0.
3. Have received any of the following within 90 days of Day 0:
• Any biologic agent (eg, adalimumab, etanercept, infliximab, anakinra) other than
B cell targeted therapy (see Exclusion Criterion 2).
• Plasmapheresis.
4. Have received any of the following within 60 days of Day 0:
• A non-biologic investigational agent.
5. Have received any of the following within 30 days of Day 0:
• A live vaccine.
6. Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
7. Have required management of acute or chronic infections, as follows:
• Currently on any suppressive therapy for a chronic infection (such as tuberculosis,
pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical
mycobacteria).
• Hospitalization for treatment of infection within 60 days of Day 0.
• Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or
anti-parasitic agents) within 60 days of Day 0.
8. Have severe lupus kidney disease (defined by proteinuria > 6 g/24 hour or equivalent
using spot urine protein to creatinine ratio, or serum creatinine > 2.5 mg/dL), or have
severe active nephritis requiring acute therapy, or have required hemodialysis or high-dose prednisone or equivalent (> 100 mg/day) within 90 days of Day 0.
9. Have severe active central nervous system (CNS) lupus (including seizures, psychosis,
organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis)
requiring therapeutic intervention.
10. Known HIV infection.
11. Current or history of hepatitis B or hepatitis C infection.
The Estimated Number of Participants
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Taiwan
175 participants
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Global
5000 participants
