Clinical Trials List
2013-05-01 - 2017-12-31
Phase III
Terminated4
Study ended1
ICD-10M32.14
Glomerular disease in systemic lupus erythematosus
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil (MMF) and Corticosteroids in Subjects with Active Class III or IV Lupus Nephritis
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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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
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yi-Ming Chen Division of Rheumatology
- 謝祖怡 Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- Chung-Ming Huang 風濕免疫科
- Jiunn-Horng Chen 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
follow-up period. The primary endpoint will be assessed at Day 365.
Inclution Criteria
a) SLE as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincidentally. The 4 criteria need not be present at the time of study entry (see Appendix 1).
b) Urine protein creatinine ratio (UPCR) ≥ 1.0 at Screening
c) Biopsy within 12 months prior to screening visit indicating active proliferative lupus
glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-G (C)] or WHO 1982 Classification Class III or IV (excluding IIIc, IVd) (see Appendix 2). NOTE:
If no prior biopsy was done for the subject at the time of the screening visit yet, the procedure can be performed during the screening period as a study procedure.
d) Evidence of active disease within 3 months of Screening, based on at least one of the following:
i) Renal Flare (defined in Section 5.4.1.4)
ii) UPCR ≥ 3 at Screening
iii) Active urine sediment, defined as at least one of the following:
• ≥ 5 red blood cells (RBC) per high power field (hpf)
• ≥ 5 white blood cells (WBC) per hpf
• presence of cellular casts
iv) Biopsy within 3 months prior to screening visit indicating active proliferative lupus
glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S
(C) and IV-G (C)] or WHO 1982 Classification Class III or IV (excluding IIIc, IVd)
(see Appendix 2). NOTE: If no prior biopsy was done for the subject at the time of the screening visit yet, the procedure can be performed during the screening period as a study procedure.
Subjects may be re-screened for urinary sediment and/or proteinuria ONCE within 2 weeks of the original screening visit.
e) Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L). Subjects not meeting this criterion but meeting all other inclusion and exclusion criteria may be re-screened for serum creatinine ONCE within 2 week of the original screening visit.
Exclusion Criteria
a) Subjects with drug-induced SLE, as opposed to idiopathic SLE.
b) Subjects with autoimmune disease other than SLE as their main diagnosis (eg; RA, MS).
c) Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic,
hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.
d) Active CNS lupus (BILAG A or B) with the exception of fatigue or mild stable cognitive dysfunction (screening MRI or other imaging of the brain is not required to rule-out CNS disease in subjects who have no clinical features suggesting active CNS disease).
e) Subjects who are diagnosed as end-stage renal disease.
f) Subjects with persistent non-lupus related pyuria or hematuria (eg, hemorrhagic cystitis).
g) Subjects with a degree of tubulo-interstitial changes that suggests a significant and irreversible decrease in renal function.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
400 participants
