Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes (NCT NCT03714022)

NCT ID: NCT03714022

Last Updated: 2021-01-07

Results Overview

Maximum Observed Serum Concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 140 participants
• Primary outcome timeframe: From drug administration to 70 days following drug administration
• Results posted on: 2021-01-07

Participant Flow

140 participants were randomized and treated.

Participant milestones

Measure	Cohort A (New Process) Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Overall Study STARTED	70	70
Overall Study COMPLETED	66	67
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Cohort A (New Process) Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Overall Study Adverse Event	1	0
Overall Study Consent withdrawal	0	1
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes

Baseline characteristics by cohort

Measure	Cohort A (New Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process	Total n=140 Participants Total of all reporting groups
Age, Continuous	36.4 Years STANDARD_DEVIATION 9.29 • n=5 Participants	36.6 Years STANDARD_DEVIATION 9.37 • n=7 Participants	36.5 Years STANDARD_DEVIATION 9.30 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	44 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	26 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	39 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Maximum Observed Serum Concentration

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Maximum Observed Serum Concentration (Cmax)	237.0341 ug/mL Geometric Coefficient of Variation 26	236.2882 ug/mL Geometric Coefficient of Variation 23

PRIMARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Area under the serum concentration-time curve from time zero extrapolated to infinity

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Area Under the Curve AUC(INF)	35693.8 ug*h/mL Geometric Coefficient of Variation 22	38254.6 ug*h/mL Geometric Coefficient of Variation 16

SECONDARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Time of maximum observed serum concentration

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Time of Maximum Observed Serum Concentration (Tmax)	1.000 Hours Interval 0.47 to 24.0	1.000 Hours Interval 0.25 to 24.0

SECONDARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Area Under the Curve AUC(0-T)	34473.2 ug*h/mL Geometric Coefficient of Variation 22	36671.6 ug*h/mL Geometric Coefficient of Variation 16

SECONDARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Area under the serum concentration-time curve from time zero to 28 days after dosing

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Area Under the Curve AUC(0-28)	28597.9 ug*h/mL Geometric Coefficient of Variation 20	29765.7 ug*h/mL Geometric Coefficient of Variation 15

SECONDARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Total body clearance

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Total Body Clearance (CLT)	0.2642 mL/h/Kg Geometric Coefficient of Variation 21	0.2445 mL/h/Kg Geometric Coefficient of Variation 17

SECONDARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Volume of distribution at steady-state

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Volume of Distribution at Steady-State (Vss)	0.10444 L/Kg Geometric Coefficient of Variation 21	0.10462 L/Kg Geometric Coefficient of Variation 21

SECONDARY outcome

Timeframe: From drug administration to 70 days following drug administration

Population: All treated participants with available concentration-time data

Terminal phase elimination half-life in serum

Outcome measures

Measure	Cohort A (New Process) n=69 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Terminal Phase Elimination Half-life (T-HALF)	357.464 Hours Standard Deviation 78.6519	369.425 Hours Standard Deviation 76.0162

SECONDARY outcome

Timeframe: From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71

Population: All treated participants with available concentration-time data

Positive immunogenicity response to Abatacept was defined if one of the following criteria was met:

1. missing baseline immunogenicity measurement and a positive, post-baseline, laboratory-reported immunogenicity response;

2. a negative laboratory-reported baseline immunogenicity response and a positive, post-baseline, laboratory-reported response;

3. a positive, laboratory-reported, baseline immunogenicity response and a positive, post-baseline, laboratory-reported immunogenicity response with a titer value greater than the baseline titer value.

Outcome measures

Measure	Cohort A (New Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Number of Participants Experiencing Positive Immunogenicity Response to Abatacept	14 Participants	11 Participants

SECONDARY outcome

Timeframe: From drug administration to 56 days following drug administration

Population: All treated participants

Number of participants experiencing different types of Adverse Events (AEs). Peri-infusional AEs: occurring during the 30 minute study drug infusion period Post-infusional AEs: occurring within 24 hours post drug infusion

Outcome measures

Measure	Cohort A (New Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Number of Participants Experiencing Adverse Events Participants with at least 1 Adverse Event	20 Participants	18 Participants
Number of Participants Experiencing Adverse Events Participants with at least 1 peri-infusional Adverse Event	1 Participants	2 Participants
Number of Participants Experiencing Adverse Events Participants with at least 1 post-infusional Adverse Event	4 Participants	3 Participants
Number of Participants Experiencing Adverse Events Participants with Adverse Event related to study drug	8 Participants	7 Participants
Number of Participants Experiencing Adverse Events Death	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events Serious Adverse Events (SAEs)	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events Adverse Events leading to discontinuation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in systolic and diastolic blood pressure values

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Blood Pressure Systolic Blood Pressure	-0.3 mmHg Standard Deviation 12.21	2.0 mmHg Standard Deviation 10.72
Change From Baseline in Blood Pressure Diastolic Blood Pressure	-0.8 mmHg Standard Deviation 7.69	-0.7 mmHg Standard Deviation 8.52

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in heart rate values

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Heart Rate	1.6 bpm Standard Deviation 9.99	0 bpm Standard Deviation 9.34

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in respiration rate values

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Respiration Rate	1.0 breath/min Standard Deviation 3.27	0.5 breath/min Standard Deviation 3.63

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in body temperature values

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Body Temperature	-0.01 C Standard Deviation 0.486	-0.06 C Standard Deviation 0.392

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in ECG parameters, including PR interval, QRS interval, QT interval, and QTC Fridericia

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval	1.6 msec Standard Deviation 17.66	-1.8 msec Standard Deviation 10.49
Change From Baseline in Electrocardiogram (ECG) Parameters QRS Interval	1.6 msec Standard Deviation 5.70	-0.0 msec Standard Deviation 5.45
Change From Baseline in Electrocardiogram (ECG) Parameters QT Interval	-1.1 msec Standard Deviation 22.53	-2.1 msec Standard Deviation 17.28
Change From Baseline in Electrocardiogram (ECG) Parameters QTC Fridericia	1.4 msec Standard Deviation 13.20	0.5 msec Standard Deviation 12.70

SECONDARY outcome

Timeframe: From the pre-treatment period to 70 days after start of study medication (approximately 100 days)

Population: All randomized participants

Number of participants experiencing clinically significant physical examination abnormal findings

Outcome measures

Measure	Cohort A (New Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in laboratory test results - Hematology parameters 1

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Laboratory Test Results - Hematology 1 Platelet Count	3.9 x10*9 cells/L Standard Deviation 30.99	-1.6 x10*9 cells/L Standard Deviation 31.81
Change From Baseline in Laboratory Test Results - Hematology 1 Basophils (absolute)	-0.026 x10*9 cells/L Standard Deviation 0.0741	-0.015 x10*9 cells/L Standard Deviation 0.0292
Change From Baseline in Laboratory Test Results - Hematology 1 Eosinophils (absolute)	-0.006 x10*9 cells/L Standard Deviation 0.1006	0.012 x10*9 cells/L Standard Deviation 0.012
Change From Baseline in Laboratory Test Results - Hematology 1 Leukocytes	0.09 x10*9 cells/L Standard Deviation 1.154	-0.07 x10*9 cells/L Standard Deviation 1.225
Change From Baseline in Laboratory Test Results - Hematology 1 Lymphocytes (absolute)	0.073 x10*9 cells/L Standard Deviation 0.5086	-0.028 x10*9 cells/L Standard Deviation 0.3162
Change From Baseline in Laboratory Test Results - Hematology 1 Monocytes (absolute)	-0.045 x10*9 cells/L Standard Deviation 0.1163	-0.033 x10*9 cells/L Standard Deviation 0.1453
Change From Baseline in Laboratory Test Results - Hematology 1 Neutrophils (absolute)	0.083 x10*9 cells/L Standard Deviation 0.9523	-0.011 x10*9 cells/L Standard Deviation 1.0654

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in laboratory test results - Hematology parameters 2

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Laboratory Test Results - Hematology 2 Basophils (relative)	-0.0034 Fraction Standard Deviation 0.00779	-0.0023 Fraction Standard Deviation 0.00462
Change From Baseline in Laboratory Test Results - Hematology 2 Eosinophils (relative)	-0.0008 Fraction Standard Deviation 0.01712	0.0024 Fraction Standard Deviation 0.01372
Change From Baseline in Laboratory Test Results - Hematology 2 Lymphocytes (relative)	0.0107 Fraction Standard Deviation 0.07609	0.0019 Fraction Standard Deviation 0.06250
Change From Baseline in Laboratory Test Results - Hematology 2 Monocytes (relative)	-0.0073 Fraction Standard Deviation 0.01389	-0.0041 Fraction Standard Deviation 0.02072
Change From Baseline in Laboratory Test Results - Hematology 2 Neutrophils (relative)	0.0008 Fraction Standard Deviation 0.08609	0.0021 Fraction Standard Deviation 0.07425

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in laboratory test results - Hematocrit

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Laboratory Test Results - Hematology 3	-0.0017 Proportion of Blood Volume Standard Deviation 0.01845	0.0014 Proportion of Blood Volume Standard Deviation 0.01767

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in laboratory test results - Chemistry parameters 1

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Laboratory Test Results - Chemistry 1 Alanine Aminotransferase (ALT)	0.6 U/L Standard Deviation 9.01	-1.3 U/L Standard Deviation 8.50
Change From Baseline in Laboratory Test Results - Chemistry 1 Alkaline Phosphatase (ALP)	-3.0 U/L Standard Deviation 7.52	-0.4 U/L Standard Deviation 8.86
Change From Baseline in Laboratory Test Results - Chemistry 1 Aspartate Aminotransferase (AST)	1.1 U/L Standard Deviation 15.89	-1.1 U/L Standard Deviation 4.11
Change From Baseline in Laboratory Test Results - Chemistry 1 Lactate Dehydrogenase (LD)	1.4 U/L Standard Deviation 47.60	-3.2 U/L Standard Deviation 18.30

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in laboratory test results - Chemistry parameters 2

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Laboratory Test Results - Chemistry 2 Bilirubin, Total	-0.25 umol/L Standard Deviation 3.467	-0.54 umol/L Standard Deviation 3.297
Change From Baseline in Laboratory Test Results - Chemistry 2 Creatinine	-2.2 umol/L Standard Deviation 9.72	-1.5 umol/L Standard Deviation 8.58
Change From Baseline in Laboratory Test Results - Chemistry 2 Bilirubin, Direct	-0.01 umol/L Standard Deviation 0.804	-0.09 umol/L Standard Deviation 0.759

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in laboratory test results - Chemistry parameters 3

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Laboratory Test Results - Chemistry 3 Blood Urea Nitrogen	0.29 mmol/L Standard Deviation 1.264	0.12 mmol/L Standard Deviation 1.125
Change From Baseline in Laboratory Test Results - Chemistry 3 Calcium, Total	-0.027 mmol/L Standard Deviation 0.0809	-0.012 mmol/L Standard Deviation 0.0787
Change From Baseline in Laboratory Test Results - Chemistry 3 Chloride, Serum	0.4 mmol/L Standard Deviation 1.83	-0.1 mmol/L Standard Deviation 2.01
Change From Baseline in Laboratory Test Results - Chemistry 3 Magnesium, Serum	-0.011 mmol/L Standard Deviation 0.0610	-0.015 mmol/L Standard Deviation 0.0666
Change From Baseline in Laboratory Test Results - Chemistry 3 Phosphorus, Inorganic	-0.010 mmol/L Standard Deviation 0.1537	-0.040 mmol/L Standard Deviation 0.1431
Change From Baseline in Laboratory Test Results - Chemistry 3 Potassium, Serum	-0.13 mmol/L Standard Deviation 0.266	-0.23 mmol/L Standard Deviation 0.311
Change From Baseline in Laboratory Test Results - Chemistry 3 Sodium, Serum	-0.1 mmol/L Standard Deviation 2.22	-0.2 mmol/L Standard Deviation 2.09
Change From Baseline in Laboratory Test Results - Chemistry 3 Glucose, Serum	0.04 mmol/L Standard Deviation 0.516	0.04 mmol/L Standard Deviation 0.383
Change From Baseline in Laboratory Test Results - Chemistry 3 Uric Acid	0.006 mmol/L Standard Deviation 0.0425	0.004 mmol/L Standard Deviation 0.0341

SECONDARY outcome

Timeframe: From baseline (last result before start of study medication) to 70 days after start of study medication

Population: All treated participants with available measurements

Mean Change from Baseline in laboratory test results - hematology and chemistry parameters 4

Outcome measures

Measure	Cohort A (New Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=67 Participants Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 Hemoglobin (g/L)	-0.6 g/L Standard Deviation 6.06	0.4 g/L Standard Deviation 5.57
Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 Albumin (g/L)	-0.9 g/L Standard Deviation 2.53	-0.3 g/L Standard Deviation 2.39
Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 Protein, Total (g/L)	-1.2 g/L Standard Deviation 4.50	-0.4 g/L Standard Deviation 4.32

Adverse Events

Cohort A (New Process)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort B (Current Process)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cohort A (New Process) n=70 participants at risk Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process	Cohort B (Current Process) n=70 participants at risk Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
Infections and infestations Nasopharyngitis	8.6% 6/70 • From drug administration to 70 days following drug administration	4.3% 3/70 • From drug administration to 70 days following drug administration

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

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