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Trial record 86 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb

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ClinicalTrials.gov Identifier: NCT01439204
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : February 4, 2014
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Rheumatoid Arthritis
Intervention Biological: Abatacept (BMS-188667)
Enrollment 223
Recruitment Details 10 October 2011 to 11 Feb 2012. Participants who were randomized to an arm were admitted to a clinical facility the day prior to dosing (Day -1) and confined until 24 hours post the single dose; participants followed to Day 71.
Pre-assignment Details Healthy participants who weighed between 60 and 100 kilograms, inclusive. 223 enrolled; 72 randomized to an arm. Reasons for not being randomized: 24 withdrew consent, 5 poor/non-compliance, 111 no longer met study criteria, 11 other. Participants were age and sex matched between treatment arms.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes. A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Period Title: Overall Study
Started 36 36
Completed 32 33
Not Completed 4 3
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             0             2
No longer meets study criteria             1             0
poor/non-compliance             3             0
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA Total
Hide Arm/Group Description A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes. A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes. Total of all reporting groups
Overall Number of Baseline Participants 36 36 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 72 participants
31.6  (10.02) 31.2  (8.90) 31.4  (9.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Female
22
  61.1%
21
  58.3%
43
  59.7%
Male
14
  38.9%
15
  41.7%
29
  40.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Hispanic or Latino
4
  11.1%
6
  16.7%
10
  13.9%
Not Hispanic or Latino
32
  88.9%
30
  83.3%
62
  86.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 36 participants 72 participants
36 36 72
Body Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 36 participants 36 participants 72 participants
78.93  (11.472) 79.39  (11.057) 79.16  (11.189)
[1]
Measure Description: An inclusion criterion was that participants would weigh between 60 and 100 kilograms (kg), inclusive.
1.Primary Outcome
Title Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).
Time Frame Days 1 to 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles. All completers had evaluable PK.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
262
(27%)
255
(21%)
2.Primary Outcome
Title Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Tmax was measured in hours (h).
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Median (Full Range)
Unit of Measure: h
1.00
(0.55 to 2.12)
1.00
(1.00 to 6.00)
3.Primary Outcome
Title Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description AUC (0 - 28) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - 28) was measured in micro grams*hours per milliliter (µg*h/mL).
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
33195
(26%)
35255
(23%)
4.Primary Outcome
Title Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description AUC (0 - T) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - T) was measured in micro grams*hour per milliliter (µg*h/mL).
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
39295
(23%)
41916
(25%)
5.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description AUC (0 - INF) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - INF) was measured in µg*h/mL.
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
40385
(23%)
43229
(27%)
6.Primary Outcome
Title Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). T-HALF was measured in hours (h).
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: h
344  (87.6) 364  (106)
7.Primary Outcome
Title Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg).
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/h/kg
0.237
(24%)
0.219
(24%)
8.Primary Outcome
Title Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
Hide Description Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Vss was measured in liters per kg body weight (L/kg).
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 32 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/kg
0.088
(33%)
0.083
(22%)
9.Secondary Outcome
Title Number of Participants With Positive Abatacept-induced Immunogenicity Response
Hide Description Immunogenicity determination was based on titers of anti-abatacept and anti- cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4-T) antibodies in serum over time. A participant had a positive abatacept-induced immunogenicity if 1 of the following criteria were met: missing baseline measurement and a positive response after baseline; negative baseline response and positive response after baseline; a baseline response and a positive response after baseline that has a titer value strictly greater than the baseline titer value. A validated, sensitive, electrochemiluminescence assay (ECL) method was used to analyze the antibodies in serum. Samples confirmed positive with ECL and with abatacept serum concentrations of less than equal to 1 µg/mL were further analyzed with a validated, in vitro, cell-based bioassay to analyze the sera containing the abatacept neutralizing activity. Samples obtained on Days 29, 57 and 71 post dose of abatacept on Day 1 (baseline).
Time Frame Days 29, 57, 71
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity Data Set: All participants with at least 1 postdose visit.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: participants
4 1
10.Secondary Outcome
Title Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population
Hide Description Blood samples obtained: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71. International Units per liter (U/L); milligram per deciliter (mg/dL); Male(M); Female (F). Reference ranges (low/high) for laboratories for which participants were identified with marked abnormalities during the study: Blood Urea Nitrogen (M/F) 10-20mg/dL ; Creatine Kinase (F) 21-21 U/L,(M) 32-294 U/L; Direct Bilirubin (M/F) 0.1-0.4 mg/dL ; Fasting Glucose (M/F) 70-110 mg/dL; Lactate Dehydrogenase (M/F) 110-209 U/L.
Time Frame Day 2 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: participants
Creatine Kinase (high) Day 2 (N=36) 1 0
Creatine Kinase (high) Day 15 (N=36,34) 1 0
Creatine Kinase (high) Day 29 (N=34,33) 2 1
Creatine Kinase (high) Day 57 (N=31,33) 1 1
Creatine Kinase (high) Day 71 (N=36,34) 1 2
Lactate Dehydrogenase (high) Day 2 (N=36) 0 1
Blood urea nitrogen (high) Day 15 (N=36,34) 1 0
Blood urea nitrogen (high) Day 29 (N=34) 0 1
Blood urea nitrogen (high) Day 71 (N=36,34) 2 0
Bilirubin Direct (high) Day 29 (N=34) 0 3
Bilirubin Direct (high) Day 71 (N=36,34) 0 1
Fasting Glucose (high) Day 71 (N=36,34) 1 0
11.Secondary Outcome
Title Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population
Hide Description Blood samples obtained: Days 2, 4, 8, 15, 22, 29, 43, 57 and 71. Male(M); Female (F). Reference ranges (low/high) for laboratory parameters for which participants were identified with marked abnormalities during the study: Leukocytes (quantitative White blood cells) (M/F) 4-11*10^3/microliters (µL); Neutrophils (absolute)(M/F) 1.4- 8.2*10^3/µL.
Time Frame Day 2 to Day 72
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: participants
Any marked abnormalities Day 2 (N=36) 0 0
Any marked abnormalities Day 15 (n=36,34) 0 0
Leukocytes (high) Day 29 (N=34,33) 0 1
Leukocytes (high) Day 57 (N=31,33) 0 1
Leukocytes (high) Day 71 (N=36,34) 1 1
Neutrophils (absolute) (high) Day 71 (N=36,34) 1 1
12.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure - Safety Population
Hide Description Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug (safety population) and had systolic assessment were included in the analysis. Days 1 and 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1 (1 hour post dose) (N=36) -6.3  (9.73) -4.5  (9.06)
Day 2 (N=36) -3.0  (12.31) -1.4  (10.35)
Day 15 (N=36,34) -1.1  (12.09) 0.3  (8.12)
Day 29 (N=33) -2.3  (10.94) -0.2  (9.65)
Day 57 (N=31,33) 1.0  (11.96) 3.4  (9.48)
Day 71 (N=36,34) 2.2  (12.09) 2.9  (9.87)
13.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population
Hide Description Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug (safety population) and had diastolic assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1 (1 hour post dose) N=36 -4.9  (5.91) -4.1  (5.78)
Day 2 (N=36) -2.3  (8.98) -0.6  (6.02)
Day 15 (N=36,34) -1.4  (7.45) 1.0  (7.29)
Day 29 (N=33) -1.9  (6.37) 0.9  (7.08)
Day 57 (N=31,33) 0.4  (7.48) 3.5  (7.56)
Day 71 (N=36,34) 1.6  (8.59) 4.0  (5.78)
14.Secondary Outcome
Title Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population
Hide Description 12-lead electrocardiograms were performed on a supine participant (5 minutes supine) at baseline (baseline = screening; Days -21 to -2) and at Day 71. QT interval and QTc were measured in mille seconds (msec). A change from baseline QT and QTc (corrected for heart rate by Fridericia formula) greater than (>) 30 msec or less than (<) 60 msec were presented, as well as values over 450 and 500 msec. QT interval on ECG image defined as: time from the beginning of the QRS (complex consisting of Q, R and S waves) to the end of the T wave.
Time Frame Day 1 to Day 71
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had at least one ECG value.
Arm/Group Title 750 mg Abatacept From Lonza, NH 750 mg Abatacept From Devens, MA
Hide Arm/Group Description:
A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: participants
Change from baseline in QT >60 msec 0 1
Change from baseline in QT >30 msec < 60 msec 5 4
Change from baseline in QTc >60 msec 0 0
Change from baseline in QTc >30 msec < 60 msec 2 2
QT > 500 msec 0 0
QT > 450 msec 0 1
QTcF >450 msec 0 0
Time Frame Day 1 to Day 71
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 750 mg Abatacept From Devens, MA 750 mg Abatacept From Lonza, NH
Hide Arm/Group Description A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes. A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
All-Cause Mortality
750 mg Abatacept From Devens, MA 750 mg Abatacept From Lonza, NH
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
750 mg Abatacept From Devens, MA 750 mg Abatacept From Lonza, NH
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
750 mg Abatacept From Devens, MA 750 mg Abatacept From Lonza, NH
Affected / at Risk (%) Affected / at Risk (%)
Total   11/36 (30.56%)   12/36 (33.33%) 
Eye disorders     
Vision blurred  1  0/36 (0.00%)  2/36 (5.56%) 
Gastrointestinal disorders     
Diarrhoea  1  2/36 (5.56%)  1/36 (2.78%) 
Infections and infestations     
Upper respiratory tract infection  1  1/36 (2.78%)  2/36 (5.56%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/36 (0.00%)  2/36 (5.56%) 
Nervous system disorders     
Dizziness  1  2/36 (5.56%)  2/36 (5.56%) 
Headache  1  5/36 (13.89%)  6/36 (16.67%) 
Renal and urinary disorders     
Dysuria  1  0/36 (0.00%)  2/36 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  3/36 (8.33%)  2/36 (5.56%) 
Cough  1  2/36 (5.56%)  4/36 (11.11%) 
Nasal congestion  1  3/36 (8.33%)  0/36 (0.00%) 
Rhinorrhoea  1  0/36 (0.00%)  3/36 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01439204     History of Changes
Other Study ID Numbers: IM101-292
First Submitted: September 21, 2011
First Posted: September 23, 2011
Results First Submitted: November 4, 2013
Results First Posted: February 4, 2014
Last Update Posted: March 19, 2014