Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
- Registration Number
- NCT00705367
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Abatacept, 30 mg/kg Abatacept - Abatacept, 10 mg/kg Abatacept Open-label long-term extension phase
- Primary Outcome Measures
Name Time Method Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs From Day 1 of double-blind period to 1st dose of long-term period 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.
Short-term Period: Number of Adverse Events (AEs) Related to Study Drug From Day 1 of double-blind period to 1st dose of long-term period 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).
Short-term Period: MeanSystolic and Diastolic Blood Pressure Day 1 predose and postdose and Day 2 Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Heart Rate Day 1 predose and postdose and Day 2 Vital signs measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Respirations Rate Day 1 predose and postdose and Day 2 Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Temperature Day 1 predose and postdose and Day 2 Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities Screening and Days 1 and 2 Laboratory tests consisted of complete blood count, chemistry, and urinalysis.
- Secondary Outcome Measures
Name Time Method Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs Days 15 to 56 days post last dose of the long-term period 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.
Minimum (Cmin) Plasma Concentration of Abatacept Days 15, 29, 85, 169, 253 and 337 Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.
Maximum (Cmax) Plasma Concentration of Abatacept Postdosing Day 1 Cmax is a drug's maximum, or peak, concentration observed after its administration.
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Days 15 to 56 days post last dose of the long-term period 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\<LLN, use \<0.5\*preRX and \<100,000/mm\^3; leukocytes (\*10\^3 c/uL): \<0.75\*LLN, \>1.25\*ULN, \<0.8\*preRX if preRX \<LLN or \>1.2\*preRX if preRX \>ULN; \>ULN if preRX \<LLN, \<LLN if \>ULN preRX; neutrophils+bands (\*10\^3 c/uL): if value \<1.00\*10\^3 c/uL; lymphocytes (\*10\^3 c/uL): if value \<0.750\*10\^3 c/uL or if value \>7.50\*10\^3 c/uL; monocytes (\*10\^3 c/uL): if value \>2000/mm\^3; basophils (\*10\^3 c/uL): if value \>400/mm\^3; eosinophils (\*10\^3 c/uL): if value\> 0.750\*10\^3 c/uL
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Days 15 to 56 days post last dose of the long-term period 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 \<LLN preRX, \>1.05\*preRX if \>ULN preRX; \>ULN if \<LLN preRX, \<LLN if \>ULN preRX; potassium: chloride: calcium: phosphorous:
Long-term Period: Number of Participants With Abatacept-specific Antibodies Day15 to 56 days post last dose of the long-term period Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.
Trial Locations
- Locations (1)
Local Institution
🇨🇳Shanghai, Shanghai, China