Trial Outcomes & Findings for Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg (NCT NCT00705367)

NCT ID: NCT00705367

Last Updated: 2013-07-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: From Day 1 of double-blind period to 1st dose of long-term period
• Results posted on: 2013-07-30

Participant Flow

Thirteen (13) participants were enrolled in the short-term period of the study. Four (4/13, 30.8%) of these participants were not randomized: 3 (23.1%) no longer met study criteria after screening, and 1 (7.7%) withdrew consent. All 9 participants who completed the short-term period entered the long-term period.

Participant milestones

Measure	Abatacept, 30/10 mg/kg Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study	Placebo/Abatacept,10 mg/kg Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
Short-term Period STARTED	6	3
Short-term Period COMPLETED	6	3
Short-term Period NOT COMPLETED	0	0
Long-term Extension Period STARTED	9	0
Long-term Extension Period COMPLETED	0	0
Long-term Extension Period NOT COMPLETED	9	0

Reasons for withdrawal

Measure	Abatacept, 30/10 mg/kg Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study	Placebo/Abatacept,10 mg/kg Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
Long-term Extension Period Adverse Event	2	0
Long-term Extension Period Withdrawal by Subject	2	0
Long-term Extension Period Lack of Efficacy	1	0
Long-term Extension Period No longer met study criteria	1	0
Long-term Extension Period Administrative reason by sponsor	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours	Total n=9 Participants Total of all reporting groups
Age Continuous	32.50 years STANDARD_DEVIATION 8.76 • n=5 Participants	41.33 years STANDARD_DEVIATION 8.33 • n=7 Participants	35.44 years STANDARD_DEVIATION 9.21 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment China	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Duration of Lupus Nephritis	41.23 months STANDARD_DEVIATION 32.90 • n=5 Participants	85.26 months STANDARD_DEVIATION 65.03 • n=7 Participants	55.90 months STANDARD_DEVIATION 47.10 • n=5 Participants
Duration of Systemic Lupus Erythematosus (SLE)	7.20 years STANDARD_DEVIATION 5.06 • n=5 Participants	11.11 years STANDARD_DEVIATION 3.18 • n=7 Participants	8.50 years STANDARD_DEVIATION 4.73 • n=5 Participants
Weight	58.83 kg STANDARD_DEVIATION 10.38 • n=5 Participants	63.67 kg STANDARD_DEVIATION 4.04 • n=7 Participants	60.44 kg STANDARD_DEVIATION 8.79 • n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 of double-blind period to 1st dose of long-term period

Population: All participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs Deaths	0 Participants	0 Participants
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs SAEs	0 Participants	0 Participants
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs AEs	3 Participants	1 Participants
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs Discontinued due to AEs	0 Participants	0 Participants
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs Acute infusional AEs	0 Participants	0 Participants
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs Peri-infusional AEs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 of double-blind period to 1st dose of long-term period

Population: All participants who received at least 1 dose of study medication.

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).

Outcome measures

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours
Short-term Period: Number of Adverse Events (AEs) Related to Study Drug Dizziness (mild)	1 Events	0 Events
Short-term Period: Number of Adverse Events (AEs) Related to Study Drug Oropharyngeal pain (mild)	1 Events	0 Events
Short-term Period: Number of Adverse Events (AEs) Related to Study Drug Diarrhea (mild)	0 Events	1 Events

PRIMARY outcome

Timeframe: Day 1 predose and postdose and Day 2

Population: All participants who received at least 1 dose of study medication.

Vital sign measurements are summarized without regard to position (sitting, standing, supine).

Outcome measures

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours
Short-term Period: MeanSystolic and Diastolic Blood Pressure Systolic blood pressure: Day 2	127.5 mm Hg Standard Deviation 13.69	126.7 mm Hg Standard Deviation 11.55
Short-term Period: MeanSystolic and Diastolic Blood Pressure Systolic blood pressure: Day 1 predose	129.0 mm Hg Standard Deviation 20.47	133.0 mm Hg Standard Deviation 8.89
Short-term Period: MeanSystolic and Diastolic Blood Pressure Systolic blood pressure: Day 1 postdose	125.8 mm Hg Standard Deviation 19.58	131.7 mm Hg Standard Deviation 9.29
Short-term Period: MeanSystolic and Diastolic Blood Pressure Diastolic blood pressure: Day 1 predose	84.2 mm Hg Standard Deviation 8.86	78.3 mm Hg Standard Deviation 12.06
Short-term Period: MeanSystolic and Diastolic Blood Pressure Diastolic blood pressure: Day 1 postdose	82.7 mm Hg Standard Deviation 9.58	82.7 mm Hg Standard Deviation 14.22
Short-term Period: MeanSystolic and Diastolic Blood Pressure Diastolic blood pressure: Day 2	79.5 mm Hg Standard Deviation 8.69	78.3 mm Hg Standard Deviation 10.41

PRIMARY outcome

Timeframe: Day 1 predose and postdose and Day 2

Population: All participants who received at least 1 dose of study medication.

Vital signs measurements are summarized without regard to position (sitting, standing, supine).

Outcome measures

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours
Short-term Period: Mean Heart Rate Day 1 predose	77.0 beats per minute Standard Deviation 8.49	81.0 beats per minute Standard Deviation 10.15
Short-term Period: Mean Heart Rate Day 1 postdose	81.2 beats per minute Standard Deviation 4.83	87.7 beats per minute Standard Deviation 19.60
Short-term Period: Mean Heart Rate Day 2	83.5 beats per minute Standard Deviation 4.46	84.0 beats per minute Standard Deviation 5.29

PRIMARY outcome

Timeframe: Day 1 predose and postdose and Day 2

Population: All participants who received at least 1 dose of study medication.

Vital sign measurements are summarized without regard to position (sitting, standing, supine).

Outcome measures

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours
Short-term Period: Mean Respirations Rate Day 1 predose	17.7 Respirations per minute Standard Deviation 2.07	19.7 Respirations per minute Standard Deviation 2.08
Short-term Period: Mean Respirations Rate Day 1 postdose	18.7 Respirations per minute Standard Deviation 1.63	20.3 Respirations per minute Standard Deviation 2.52
Short-term Period: Mean Respirations Rate Day 2	14.0 Respirations per minute Standard Deviation 3.35	17.3 Respirations per minute Standard Deviation 1.15

PRIMARY outcome

Timeframe: Day 1 predose and postdose and Day 2

Population: All participants who received at least 1 dose of study medication.

Vital sign measurements are summarized without regard to position (sitting, standing, supine).

Outcome measures

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours
Short-term Period: Mean Temperature Day 1 predose	36.7 Degrees Celsius Standard Deviation 0.51	36.7 Degrees Celsius Standard Deviation 0.15
Short-term Period: Mean Temperature Day 1 postdose	36.8 Degrees Celsius Standard Deviation 0.59	36.9 Degrees Celsius Standard Deviation 0.26
Short-term Period: Mean Temperature Day 2	36.9 Degrees Celsius Standard Deviation 0.11	36.9 Degrees Celsius Standard Deviation 0.12

PRIMARY outcome

Timeframe: Screening and Days 1 and 2

Population: All participants who received at least 1 dose of study drug

Laboratory tests consisted of complete blood count, chemistry, and urinalysis.

Outcome measures

Measure	Abatacept (30 mg/kg) n=6 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo n=3 Participants Infusion, Intravenous, single dose, 24 hours
Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities Laboratory Abnormalities	0 Participants	0 Participants
Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities ECG Abnormalities	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 15 to 56 days post last dose of the long-term period

Population: All participants who received at least 1 infusion of abatacept during the open-label long-term extension period of the study.

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.

Outcome measures

Measure	Abatacept (30 mg/kg) n=9 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo Infusion, Intravenous, single dose, 24 hours
Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs Deaths	0 Participants	—
Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs SAEs	0 Participants	—
Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs Discontinuations due to AEs	2 Participants	—
Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs AEs	8 Participants	—
Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs Treatment-related AEs	6 Participants	—

SECONDARY outcome

Timeframe: Days 15, 29, 85, 169, 253 and 337

Population: All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.

Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.

Outcome measures

Measure	Abatacept (30 mg/kg) n=9 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo Infusion, Intravenous, single dose, 24 hours
Minimum (Cmin) Plasma Concentration of Abatacept Day 15 (n=6)	55.47 ug/mL Standard Deviation 29.356	—
Minimum (Cmin) Plasma Concentration of Abatacept Day 29 (N=9)	42.69 ug/mL Standard Deviation 12.534	—
Minimum (Cmin) Plasma Concentration of Abatacept Day 85 (n=8)	18.54 ug/mL Standard Deviation 11.492	—
Minimum (Cmin) Plasma Concentration of Abatacept Day 169 (n=7)	22.66 ug/mL Standard Deviation 10.312	—
Minimum (Cmin) Plasma Concentration of Abatacept Day 253 (n=7)	28.24 ug/mL Standard Deviation 13.883	—
Minimum (Cmin) Plasma Concentration of Abatacept Day 337 (n=4)	25.98 ug/mL Standard Deviation 6.833	—

SECONDARY outcome

Timeframe: Postdosing Day 1

Population: All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.

Cmax is a drug's maximum, or peak, concentration observed after its administration.

Outcome measures

Measure	Abatacept (30 mg/kg) n=4 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo Infusion, Intravenous, single dose, 24 hours
Maximum (Cmax) Plasma Concentration of Abatacept	463.10 ug/mL Geometric Coefficient of Variation 17	—

SECONDARY outcome

Timeframe: Days 15 to 56 days post last dose of the long-term period

Population: All participants who received at least 1 dose of study medication.

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

Outcome measures

Measure	Abatacept (30 mg/kg) n=9 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo Infusion, Intravenous, single dose, 24 hours
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute basophils (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Hemoglobin (low)	1 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Hemoglobin (high)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Hematocrit (low)	1 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Hematocrit (high)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Erythrocytes (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Erythrocytes (high)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Platelet count (low or high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Leukocytes (low)	1 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Leukocytes (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Neutrophils +bands (absolute) (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Neutrophils +bands (absolute) (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute lymphocytes (low)	6 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute lymphocytes (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute monocytes (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute monocytes (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute basophils (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute eosinophils (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Absolute eosinophils (high)	0 Participants	—

SECONDARY outcome

Timeframe: Days 15 to 56 days post last dose of the long-term period

Population: All participants who received at least 1 dose of study medication.

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<LLN, use <0.8*preRX or >ULN; if preRX>ULN, use >2.0*preRX or <LLN. Protein, total (g/dL): <0.9*LLN or >1.1*ULN; if preRX<LLN, use 0.9*preRX or >ULN if preRX >ULN, use 1.1*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX<LLN use <0.75*preRX. Uric acid (mg/dL): >1.5*ULN; if preRX>ULN use >2*preRX. Protein, urine: if missing preRX, use>=2; if >=4; if preRX=0 or 0.5, use >=2; if preRX=1, use >=3, or if preRX=2 or 3, use >= 4. Glucose, urine: if preRX missing, use >=2; if >=4, or if preRX=0 or 0.5 use >=2,or if preRX=1, use >=3, or if preRX=2 or 3 use >=4. Blood, urine: if preRX missing, use>= 2, or if >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3; if preRX=2 or 3 use >=4. WBC, urine (hpf): if missing preRX, use>= 2, or if >= 4, or if preRX =0 or 0.5 use >=2, or if preRX=1 use >=3, or if preRX=2 or 3 use >=4.

Outcome measures

Measure	Abatacept (30 mg/kg) n=9 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo Infusion, Intravenous, single dose, 24 hours
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Glucose, serum (low)	2 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Glucose, serum (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Glucose, fasting serum (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Glucose, fasting serum (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Protein, total (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Protein, total (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Albumin (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Albumin (high)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Uric acid (low)	NA Participants Not evaluable	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Uric acid (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Protein, urine (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Protein, urine (high)	1 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Glucose, urine (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Glucose, urine (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Blood, urine (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Blood, urine (high)	5 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) WBC, urine (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) White blood cell (WBC) count, urine (high)	3 Participants	—

SECONDARY outcome

Timeframe: Days 15 to 56 days post last dose of the long-term period

Population: All participants who received at least 1 dose of study medication.

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:

Outcome measures

Measure	Abatacept (30 mg/kg) n=9 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo Infusion, Intravenous, single dose, 24 hours
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Alkaline phosphatase (ALP) (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) ALP (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Aspartate aminotransferase (AST) (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) AST (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Alanine aminotransferase (ALT) (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) ALT (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) G-glutamyl transferase (GGT) (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) GGT (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Bilirubin, total (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Bilirubin, total (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Blood urea nitrogen (BUN) (low)	NA Participants Not evaluated	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) BUN (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Sodium, serum (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Sodium, serum (high)	1 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Potassium, serum (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Potassium, serum (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Chloride, serum (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Chloride, serum (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Calcium, total (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Calcium, total (high)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Phosphorus, inorganic (low)	0 Participants	—
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) Phosphorus, inorganic (high)	2 Participants	—

SECONDARY outcome

Timeframe: Day15 to 56 days post last dose of the long-term period

Population: All participants who received at least 1 dose of abatacept and had an immunogenicity test result.

Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.

Outcome measures

Measure	Abatacept (30 mg/kg) n=9 Participants Infusion, Intravenous, 30 mg/kg, single dose, 24 hours	Placebo Infusion, Intravenous, single dose, 24 hours
Long-term Period: Number of Participants With Abatacept-specific Antibodies	0 Participants	—

Adverse Events

Abatacept 30 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Abatacept 30 mg/kg n=6 participants at risk	Placebo n=3 participants at risk
Nervous system disorders DIZZINESS	16.7% 1/6	0.00% 0/3
Gastrointestinal disorders VOMITING	16.7% 1/6	0.00% 0/3
Gastrointestinal disorders DIARRHOEA	16.7% 1/6	33.3% 1/3
Gastrointestinal disorders ABDOMINAL PAIN	16.7% 1/6	0.00% 0/3
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	16.7% 1/6	0.00% 0/3

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER