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The main objective of this study is to compare the pharmacokinetics (PK) of the abatacept drug product converted from drug substance by a new drug substance process (Treatment A) relative to the current drug substance process (Treatment B) following a single dose (750 mg) intravenous (IV) infusion in healthy participants.
Participants will be admitted to the clinical facility the day prior to dosing (Day -1) and will be confined until at least 24 hours post-dose. On Day 1, eligible participants will be randomized in a 1:1 ratio to either Treatment A or Treatment B. The randomization will be stratified by weight categories: >= 60 to < 70 kg, >= 70 to < 80 kg, >= 80 to < 90 kg, and >= 90 to <= 100 kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive abatacept at a single dose of 750 mg as IV infusion on Day 1 converted from drug substance by a new process. |
|
| Treatment B | Active Comparator | Participants will receive abatacept at a single dose 750 mg as IV infusion on Day 1 converted from drug substance by converted from drug substance by the current process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Participants will receive abatacept at a single dose 750 mg as IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Maximum Observed Serum Concentration | From drug administration to 70 days following drug administration |
| Area Under the Curve AUC(INF) | Area under the serum concentration-time curve from time zero extrapolated to infinity | From drug administration to 70 days following drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Observed Serum Concentration (Tmax) | Time of maximum observed serum concentration | From drug administration to 70 days following drug administration |
| Area Under the Curve AUC(0-T) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States | ||
| PPD Development, LP |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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140 participants were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A (New Process) | Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process |
| FG001 | Cohort B (Current Process) | Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A (New Process) | Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process |
| BG001 | Cohort B (Current Process) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Serum Concentration (Cmax) | Maximum Observed Serum Concentration | All treated participants with available concentration-time data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | From drug administration to 70 days following drug administration |
|
From drug administration to 70 days following drug administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A (New Process) | Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2018 | Dec 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2019 | Dec 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration
| From drug administration to 70 days following drug administration |
| Area Under the Curve AUC(0-28) | Area under the serum concentration-time curve from time zero to 28 days after dosing | From drug administration to 70 days following drug administration |
| Total Body Clearance (CLT) | Total body clearance | From drug administration to 70 days following drug administration |
| Volume of Distribution at Steady-State (Vss) | Volume of distribution at steady-state | From drug administration to 70 days following drug administration |
| Terminal Phase Elimination Half-life (T-HALF) | Terminal phase elimination half-life in serum | From drug administration to 70 days following drug administration |
| Number of Participants Experiencing Positive Immunogenicity Response to Abatacept | Positive immunogenicity response to Abatacept was defined if one of the following criteria was met:
| From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71 |
| Number of Participants Experiencing Adverse Events | 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 | From drug administration to 56 days following drug administration |
| Change From Baseline in Blood Pressure | Mean Change from Baseline in systolic and diastolic blood pressure values | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Heart Rate | Mean Change from Baseline in heart rate values | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Respiration Rate | Mean Change from Baseline in respiration rate values | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Body Temperature | Mean Change from Baseline in body temperature values | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Electrocardiogram (ECG) Parameters | Mean Change from Baseline in ECG parameters, including PR interval, QRS interval, QT interval, and QTC Fridericia | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities | Number of participants experiencing clinically significant physical examination abnormal findings | From the pre-treatment period to 70 days after start of study medication (approximately 100 days) |
| Change From Baseline in Laboratory Test Results - Hematology 1 | Mean Change from Baseline in laboratory test results - Hematology parameters 1 | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Laboratory Test Results - Hematology 2 | Mean Change from Baseline in laboratory test results - Hematology parameters 2 | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Laboratory Test Results - Hematology 3 | Mean Change from Baseline in laboratory test results - Hematocrit | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Laboratory Test Results - Chemistry 1 | Mean Change from Baseline in laboratory test results - Chemistry parameters 1 | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Laboratory Test Results - Chemistry 2 | Mean Change from Baseline in laboratory test results - Chemistry parameters 2 | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Laboratory Test Results - Chemistry 3 | Mean Change from Baseline in laboratory test results - Chemistry parameters 3 | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 | Mean Change from Baseline in laboratory test results - hematology and chemistry parameters 4 | From baseline (last result before start of study medication) to 70 days after start of study medication |
| Austin |
| Texas |
| 78744 |
| United States |
| FDA Safety Alerts and Recalls | View source |
| Lost to Follow-up |
|
Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | Area Under the Curve AUC(INF) | Area under the serum concentration-time curve from time zero extrapolated to infinity | All treated participants with available concentration-time data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*h/mL | From drug administration to 70 days following drug administration |
|
|
|
|
| Secondary | Time of Maximum Observed Serum Concentration (Tmax) | Time of maximum observed serum concentration | All treated participants with available concentration-time data | Posted | Median | Full Range | Hours | From drug administration to 70 days following drug administration |
|
|
|
| Secondary | Area Under the Curve AUC(0-T) | Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration | All treated participants with available concentration-time data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*h/mL | From drug administration to 70 days following drug administration |
|
|
|
|
| Secondary | Area Under the Curve AUC(0-28) | Area under the serum concentration-time curve from time zero to 28 days after dosing | All treated participants with available concentration-time data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*h/mL | From drug administration to 70 days following drug administration |
|
|
|
|
| Secondary | Total Body Clearance (CLT) | Total body clearance | All treated participants with available concentration-time data | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h/Kg | From drug administration to 70 days following drug administration |
|
|
|
| Secondary | Volume of Distribution at Steady-State (Vss) | Volume of distribution at steady-state | All treated participants with available concentration-time data | Posted | Geometric Mean | Geometric Coefficient of Variation | L/Kg | From drug administration to 70 days following drug administration |
|
|
|
| Secondary | Terminal Phase Elimination Half-life (T-HALF) | Terminal phase elimination half-life in serum | All treated participants with available concentration-time data | Posted | Mean | Standard Deviation | Hours | From drug administration to 70 days following drug administration |
|
|
|
| Secondary | Number of Participants Experiencing Positive Immunogenicity Response to Abatacept | Positive immunogenicity response to Abatacept was defined if one of the following criteria was met:
| All treated participants with available concentration-time data | Posted | Count of Participants | Participants | From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71 |
|
|
|
| Secondary | Number of Participants Experiencing Adverse Events | 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 | All treated participants | Posted | Count of Participants | Participants | From drug administration to 56 days following drug administration |
|
|
|
| Secondary | Change From Baseline in Blood Pressure | Mean Change from Baseline in systolic and diastolic blood pressure values | All treated participants with available measurements | Posted | Mean | Standard Deviation | mmHg | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Heart Rate | Mean Change from Baseline in heart rate values | All treated participants with available measurements | Posted | Mean | Standard Deviation | bpm | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Respiration Rate | Mean Change from Baseline in respiration rate values | All treated participants with available measurements | Posted | Mean | Standard Deviation | breath/min | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Body Temperature | Mean Change from Baseline in body temperature values | All treated participants with available measurements | Posted | Mean | Standard Deviation | C | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters | Mean Change from Baseline in ECG parameters, including PR interval, QRS interval, QT interval, and QTC Fridericia | All treated participants with available measurements | Posted | Mean | Standard Deviation | msec | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities | Number of participants experiencing clinically significant physical examination abnormal findings | All randomized participants | Posted | Count of Participants | Participants | From the pre-treatment period to 70 days after start of study medication (approximately 100 days) |
|
|
|
| Secondary | Change From Baseline in Laboratory Test Results - Hematology 1 | Mean Change from Baseline in laboratory test results - Hematology parameters 1 | All treated participants with available measurements | Posted | Mean | Standard Deviation | x10*9 cells/L | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Laboratory Test Results - Hematology 2 | Mean Change from Baseline in laboratory test results - Hematology parameters 2 | All treated participants with available measurements | Posted | Mean | Standard Deviation | Fraction | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Laboratory Test Results - Hematology 3 | Mean Change from Baseline in laboratory test results - Hematocrit | All treated participants with available measurements | Posted | Mean | Standard Deviation | Proportion of Blood Volume | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Laboratory Test Results - Chemistry 1 | Mean Change from Baseline in laboratory test results - Chemistry parameters 1 | All treated participants with available measurements | Posted | Mean | Standard Deviation | U/L | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Laboratory Test Results - Chemistry 2 | Mean Change from Baseline in laboratory test results - Chemistry parameters 2 | All treated participants with available measurements | Posted | Mean | Standard Deviation | umol/L | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Laboratory Test Results - Chemistry 3 | Mean Change from Baseline in laboratory test results - Chemistry parameters 3 | All treated participants with available measurements | Posted | Mean | Standard Deviation | mmol/L | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| Secondary | Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 | Mean Change from Baseline in laboratory test results - hematology and chemistry parameters 4 | All treated participants with available measurements | Posted | Mean | Standard Deviation | g/L | From baseline (last result before start of study medication) to 70 days after start of study medication |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 6 |
| 70 |
| EG001 | Cohort B (Current Process) | Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process | 0 | 70 | 0 | 70 | 3 | 70 |
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| Participants with at least 1 post-infusional Adverse Event |
|
| Participants with Adverse Event related to study drug |
|
| Death |
|
| Serious Adverse Events (SAEs) |
|
| Adverse Events leading to discontinuation |
|
| QT Interval |
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| QTC Fridericia |
|
| Eosinophils (absolute) |
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| Leukocytes |
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| Lymphocytes (absolute) |
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| Monocytes (absolute) |
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| Neutrophils (absolute) |
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| Lymphocytes (relative) |
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| Monocytes (relative) |
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| Neutrophils (relative) |
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| Aspartate Aminotransferase (AST) |
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| Lactate Dehydrogenase (LD) |
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| Creatinine |
|
| Chloride, Serum |
|
| Magnesium, Serum |
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| Phosphorus, Inorganic |
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| Potassium, Serum |
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| Sodium, Serum |
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| Glucose, Serum |
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| Uric Acid |
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| Protein, Total (g/L) |
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