Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg

Lupus Nephritis Clinical Trial

Official title:

A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705367
• Other study ID #: IM101-217
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2008
• Last updated: July 23, 2013
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis

• Stable renal disease

• No flaring of other organ systems in a minimum of the last 3 months

Exclusion Criteria:

• Unstable lupus nephritis and serum creatinine >3 mg/dL

• Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis

• Severe unstable, refractory, or progressive SLE

• History of cancer

• Participants at risk for tuberculosis

• Autoimmune disease other than SLE as main diagnosis

• Human immunodeficiency virus or herpes zoster infection

• Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Placebo
Infusion, Intravenous, single dose, Day 1
• Abatacept
Infusion, Intravenous, 30mg/kg, single dose, Day 1
• Abatacept
Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study

Locations

Country	Name	City	State
China	Local Institution	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

References & Publications (1)

Liu MF, Wang CR, Lin LC, Wu CR. CTLA-4 gene polymorphism in promoter and exon-1 regions in Chinese patients with systemic lupus erythematosus. Lupus. 2001;10(9):647-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.	From Day 1 of double-blind period to 1st dose of long-term period	Yes
Primary	Short-term Period: Number of Adverse Events (AEs) Related to Study Drug	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).	From Day 1 of double-blind period to 1st dose of long-term period	Yes
Primary	Short-term Period: MeanSystolic and Diastolic Blood Pressure	Vital sign measurements are summarized without regard to position (sitting, standing, supine).	Day 1 predose and postdose and Day 2	Yes
Primary	Short-term Period: Mean Heart Rate	Vital signs measurements are summarized without regard to position (sitting, standing, supine).	Day 1 predose and postdose and Day 2	Yes
Primary	Short-term Period: Mean Respirations Rate	Vital sign measurements are summarized without regard to position (sitting, standing, supine).	Day 1 predose and postdose and Day 2	Yes
Primary	Short-term Period: Mean Temperature	Vital sign measurements are summarized without regard to position (sitting, standing, supine).	Day 1 predose and postdose and Day 2	Yes
Primary	Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities	Laboratory tests consisted of complete blood count, chemistry, and urinalysis.	Screening and Days 1 and 2	Yes
Secondary	Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs	AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.	Days 15 to 56 days post last dose of the long-term period	Yes
Secondary	Minimum (Cmin) Plasma Concentration of Abatacept	Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.	Days 15, 29, 85, 169, 253 and 337	No
Secondary	Maximum (Cmax) Plasma Concentration of Abatacept	Cmax is a drug's maximum, or peak, concentration observed after its administration.	Postdosing Day 1	No
Secondary	Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests	preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): >3g/dL drop from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/L): <0.67*LLN or >1.5*ULN, or <100,000/mm^3 or if preRX	Days 15 to 56 days post last dose of the long-term period	Yes
Secondary	Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)	preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): <65 or >220. Glucose, fasting(mg/dL): <0.8*LLN or >1.5* ULN; if preRX	Days 15 to 56 days post last dose of the long-term period	Yes
Secondary	Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)	ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3X*ULN, or if preRX>ULN, use >4*preRX; GGT (/L): >*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; BUN (mg/dL):>2*preRX; sodium: <.95*LLN, >1.05*ULN, <.95* preRX if	Days 15 to 56 days post last dose of the long-term period	Yes
Secondary	Long-term Period: Number of Participants With Abatacept-specific Antibodies	Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.	Day15 to 56 days post last dose of the long-term period	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm