Pilot Study to Evaluate the Safety and Efficacy of Abatac... | NCT02592798 | Trialant
NCT02592798
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Mar 5, 2021Actual
Enrollment
36Actual
Phase
Phase 2
Conditions
Nephrotic Syndrome
Focal Segmental Glomerulosclerosis
Minimal Change Disease
Interventions
Abatacept
Normal Saline
D5W
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02592798
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM101-566
Secondary IDs
ID
Type
Description
Link
2015-005450-36
EudraCT Number
Brief Title
Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
Official Title
A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Feb 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 9, 2016Actual
Primary Completion Date
Jan 28, 2020Actual
Completion Date
Jan 28, 2020Actual
First Submitted Date
Oct 29, 2015
First Submission Date that Met QC Criteria
Oct 29, 2015
First Posted Date
Oct 30, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 19, 2021
Results First Submitted that Met QC Criteria
Feb 10, 2021
Results First Posted Date
Mar 5, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 10, 2021
Last Update Posted Date
Mar 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Nephrotic Syndrome
Focal Segmental Glomerulosclerosis
Minimal Change Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
36Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Abatacept
Experimental
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Drug: Abatacept
Placebo
Placebo Comparator
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Other: Normal Saline
Other: D5W
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Abatacept
Drug
Abatacept IV administered on Day 1, 15, 29 and then every 28 days
Abatacept
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants in Renal Response at Day 113
Renal Response is defined as the presence of all the following criteria:
PROTEINURIA: Reduction of baseline urine protein/creatinine ratio (UPCR) of >= 50% and to less than 3.
RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline.
From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113
From baseline (measured at day 1 of study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)
Mean Change From Baseline in Serum Albumine at Day 113
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Male and female subjects ages ≥ 6 years
Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these
UPCR ≥ 3 at screening
FSGS or MCD confirmed by renal biopsy
eGFR ≥ 45 for children and adults
Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks or have intolerance documented in the source documents maintained at the site
Exclusion Criteria:
Kidney diseases other than FSGS or MCD
Collapsing FSGS
Systemic lupus erythematosus
Diabetes mellitus, both type 1 and type 2
Clinically significant congestive heart failure
Post renal transplantation, including relapsing post-transplant FSGS
Body mass index (BMI): > 40 in subjects ≥ 18 years of age and ≥ 99% percentile for subjects < 18 years of age
Other protocol defined inclusion/exclusion criteria may apply
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Normal Saline administer on Day 1, 15, 29 and then every 28 days
Placebo
D5W
Other
Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days
Placebo
5% Dextrose in Water
From baseline (measured at day 1 of the study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)
Percentage of Participants Achieving Complete Remission at Day 113
Complete Remission is defined as the presence of all the following criteria:
PROTEINURIA: Urine protein/creatinine ratio (UPCR) ≤ 0.3. RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline.
From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Adult Participants
PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:
Fatigue: Short From (SF) Fatigue v1.0 Adult 8a, composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).
Pain Interference: SF Pain Interference v1.0 Adult 8a, (measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).
Physical Function: SF Physical Function v1.2 Adult 8b, composed of 8 questions, each one scored from 1 (Without any difficulty) to 5 (Unable to do). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).
From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Pediatric Participants
PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:
Fatigue: Short From (SF) Fatigue v1.0 Peds 10a, composed of 10 questions, each one scored from 0 (Never) to 4 (Almost Always). Output presented as Total score, ranging from 0 (most desirable outcome) to 40 (least desirable outcome).
Pain Interference: SF Pain Interference v1.0 Peds 8a, ( measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 0 (Never) to 4 (Almost always). Output presented as Total score, ranging from 0 (most desirable outcome) to 32 (least desirable outcome).
Mobility: SF Physical Function-Mobility v1.0 Peds 8a, composed of 8 questions, each one scored from 0 (Not able to do) to 4 (With no trouble). Output presented as Total score, ranging from 0 (least desirable outcome) to 32 (most desirable outcome).
From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period
Number of Participants Experiencing Adverse Events
This outcome describes the number of participants experiencing various types of any grade Adverse Events (AEs).
The Cumulative Abatacept Safety Period starts at the time of the first dose of Abatacept (either in the Double-Blind Period or in the Open Label Period) and lasts 56 days after the last dose of Abatacept
From first dose in the indicated period to 56 days following last dose in the indicated period (169 days for the Double-Blind Period, up to 337 days for the Cumulative Abatacept Safety Period)
Number of Participants Experiencing Adverse Events of Special Interest
Number of participants experiencing various types of Adverse Events of interest, including infections, malignancies, autoimmune disorders, and infusional related reactions.
From first dose on day 1 to 56 days following last dose (approximately 330 days)
Percentage of Participants With Positive Antibody Response Relative to Baseline
A positive response relative to baseline is defined as a positive response at a post-baseline visit that has a titer value greater than the positive baseline titer value. If the baseline titer is missing or negative, any post-baseline positive titer value is considered a positive response relative to baseline.
Immunogenicity response is presented as the total of immunogenicity response for "CTLA4 and possibly Ig" and "Ig and/or Junction Region".
From baseline (day 1) to 168 days following last dose (up to 15 months). Results at day 113 from first dose, day 56, day 84 and day 168 after last dose are presented
Minimum Blood Plasma Concentration (Cmin) of Abatacept - Adult Participants
From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113
Minimum Blood Plasma Concentration (Cmin) of Abatacept - Pediatric Participants
From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113
Maximum Observed Serum Concentration (Cmax) of Abatacept
Day 85 after first dose in the Double Blind Period
Area Under the Serum Concentration Time Curve Over a Dosing Interval (AUC(TAU)) of Abatacept
From Day 85 to Day 113 in the Double Blind Period
Time to Reach Peak Serum Concentration (Tmax(h)) of Abatacept
Day 85 after first dose in the Double Blind Period
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
FG00017 subjects
FG00119 subjects
COMPLETED
FG00014 subjects
FG00113 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
Type
Comment
Reasons
Pregnancy
FG0001 subjects
FG0010 subjects
No longer meeting study criteria
FG0000 subjects
FG0011 subjects
Lack of Efficacy
FG0001 subjects
FG0013 subjects
Adverse Event
FG0001 subjects
FG0012 subjects
Transition From DB1 to DB2
Type
Comment
Milestone Data
STARTED
FG00014 subjects
FG00113 subjects
COMPLETED
FG00011 subjects
FG00111 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
Type
Comment
Reasons
Skipped DB2 and moved into subsequent OLE
FG0003 subjects
FG0012 subjects
Double-Blind Period 2 (DB2)
Type
Comment
Milestone Data
STARTED
FG00011 subjects
FG00111 subjects
COMPLETED
FG0006 subjects
FG0019 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
Type
Comment
Reasons
Other reasons
FG0001 subjects
FG0010 subjects
Participant request to discontinue
FG0001 subjects
FG001
Transition From DB2 to OLE
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0019 subjects
COMPLETED
FG0005 subjects
FG0019 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
Type
Comment
Reasons
Other reasons
FG0001 subjects
FG0010 subjects
Open Label Period (OLE)
Type
Comment
Milestone Data
STARTED
The starting pool of OLE period consists of participants who completed the Double-Blind Period + participants who escaped from DB1 and/or DB2 to OLE period
FG00010 subjects
FG00113 subjects
COMPLETED
FG0006 subjects
FG0014 subjects
NOT COMPLETED
FG0004 subjects
FG0019 subjects
Type
Comment
Reasons
Other reasons
FG0000 subjects
FG0012 subjects
Participant request to discontinue
FG0001 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
BG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00017
BG00119
BG00236
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00022.5± 13.21
BG00128.7± 19.35
BG00225.8± 16.80
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG00112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Percentage of Participants in Renal Response at Day 113
Renal Response is defined as the presence of all the following criteria:
PROTEINURIA: Reduction of baseline urine protein/creatinine ratio (UPCR) of >= 50% and to less than 3.
RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline.
All treated participants with available measurements
Posted
Number
95% Confidence Interval
Percent of Participants
From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG00017
OG00119
Title
Denominators
Categories
Double-Blind Period Day 113
ParticipantsOG00013
ParticipantsOG00113
Title
Measurements
OG0000.0(0.0 to 24.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Final Values)
-7.7
2-Sided
95
-46.8
33.3
Abatacept - Placebo for Double-Blind Period Day 113
Superiority
OG000
OG001
Secondary
Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113
All treated participants with available measurements
Posted
Mean
Standard Error
mg/mg
From baseline (measured at day 1 of study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG000
Secondary
Mean Change From Baseline in Serum Albumine at Day 113
All treated participants with available measurements
Posted
Mean
Standard Error
g/dL
From baseline (measured at day 1 of the study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving Complete Remission at Day 113
Complete Remission is defined as the presence of all the following criteria:
PROTEINURIA: Urine protein/creatinine ratio (UPCR) ≤ 0.3. RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline.
All treated participants with available measurements
Posted
Number
95% Confidence Interval
Percent of Participants
From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Secondary
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Adult Participants
PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:
Fatigue: Short From (SF) Fatigue v1.0 Adult 8a, composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).
Pain Interference: SF Pain Interference v1.0 Adult 8a, (measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).
Physical Function: SF Physical Function v1.2 Adult 8b, composed of 8 questions, each one scored from 1 (Without any difficulty) to 5 (Unable to do). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).
All treated participants with available measurements
Posted
Mean
Standard Error
Score on a scale
From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Secondary
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Pediatric Participants
PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:
Fatigue: Short From (SF) Fatigue v1.0 Peds 10a, composed of 10 questions, each one scored from 0 (Never) to 4 (Almost Always). Output presented as Total score, ranging from 0 (most desirable outcome) to 40 (least desirable outcome).
Pain Interference: SF Pain Interference v1.0 Peds 8a, ( measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 0 (Never) to 4 (Almost always). Output presented as Total score, ranging from 0 (most desirable outcome) to 32 (least desirable outcome).
Mobility: SF Physical Function-Mobility v1.0 Peds 8a, composed of 8 questions, each one scored from 0 (Not able to do) to 4 (With no trouble). Output presented as Total score, ranging from 0 (least desirable outcome) to 32 (most desirable outcome).
All treated participants with available measurements
Posted
Mean
Standard Error
Score on a scale
From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Secondary
Number of Participants Experiencing Adverse Events
This outcome describes the number of participants experiencing various types of any grade Adverse Events (AEs).
The Cumulative Abatacept Safety Period starts at the time of the first dose of Abatacept (either in the Double-Blind Period or in the Open Label Period) and lasts 56 days after the last dose of Abatacept
All treated participants
Posted
Count of Participants
Participants
From first dose in the indicated period to 56 days following last dose in the indicated period (169 days for the Double-Blind Period, up to 337 days for the Cumulative Abatacept Safety Period)
ID
Title
Description
OG000
Abatacept During Double-Blind Period
Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
OG001
Placebo During Double-Blind Period
Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
OG002
Abatacept During Cumulative Abatacept Safety Period
Any participants receiving at least 1 dose of Abatacept, starting either in the Double-Blind Period or in the Open Label Period
Secondary
Number of Participants Experiencing Adverse Events of Special Interest
Number of participants experiencing various types of Adverse Events of interest, including infections, malignancies, autoimmune disorders, and infusional related reactions.
All treated participants
Posted
Count of Participants
Participants
From first dose on day 1 to 56 days following last dose (approximately 330 days)
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
Secondary
Percentage of Participants With Positive Antibody Response Relative to Baseline
A positive response relative to baseline is defined as a positive response at a post-baseline visit that has a titer value greater than the positive baseline titer value. If the baseline titer is missing or negative, any post-baseline positive titer value is considered a positive response relative to baseline.
Immunogenicity response is presented as the total of immunogenicity response for "CTLA4 and possibly Ig" and "Ig and/or Junction Region".
All treated participants with available measurements
Posted
Number
Percent of Participants
From baseline (day 1) to 168 days following last dose (up to 15 months). Results at day 113 from first dose, day 56, day 84 and day 168 after last dose are presented
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Secondary
Minimum Blood Plasma Concentration (Cmin) of Abatacept - Adult Participants
All adult participants receiving Abatacept during the Double Blind Period with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG000
Secondary
Minimum Blood Plasma Concentration (Cmin) of Abatacept - Pediatric Participants
All pediatric participants receiving Abatacept during the Double Blind Period with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG000
Secondary
Maximum Observed Serum Concentration (Cmax) of Abatacept
All participants receiving Abatacept during the Double Blind Period with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Day 85 after first dose in the Double Blind Period
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG000
Secondary
Area Under the Serum Concentration Time Curve Over a Dosing Interval (AUC(TAU)) of Abatacept
All participants receiving Abatacept during the Double Blind Period with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
ug*h/mL
From Day 85 to Day 113 in the Double Blind Period
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG000
Secondary
Time to Reach Peak Serum Concentration (Tmax(h)) of Abatacept
All participants receiving Abatacept during the Double Blind Period with available measurements
Posted
Mean
Standard Deviation
Hours
Day 85 after first dose in the Double Blind Period
ID
Title
Description
OG000
Abatacept
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
OG001
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG000
Time Frame
From first dose to 100 days following administration of last dose (approximately 1 year)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Abatacept During Double-Blind Period 1 (DB1)
Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
0
17
5
17
13
17
EG001
Placebo During Double-Blind Period 1 (DB1)
Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
0
19
4
19
15
19
EG002
Abatacept During Double-Blind Period 2 (DB2)
Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
0
11
0
11
7
11
EG003
Placebo During Double-Blind Period 2 (DB2)
Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
0
11
2
11
8
11
EG004
Abatacept During Open Label Period (OLE)
Abatacept IV administered every 28 days
0
23
6
23
16
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG0031 affected11 at risk
EG0040 affected23 at risk
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Periorbital swelling
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Generalised oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Renal disorder
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG0031 affected11 at risk
EG0041 affected23 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Nephrogenic anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0004 affected17 at risk
EG0013 affected19 at risk
EG0020 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected17 at risk
EG0012 affected19 at risk
EG0021 affected11 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0005 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Complication associated with device
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Energy increased
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Face oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Feeling cold
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Malaise
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Nodule
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0004 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected19 at risk
EG0020 affected11 at risk
EG003
Pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Swelling
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Furuncle
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0021 affected11 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Heat cramps
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0002 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Blood pressure increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Influenza A virus test positive
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Respiratory syncytial virus test positive
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Weight increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0021 affected11 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected17 at risk
EG0015 affected19 at risk
EG0021 affected11 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Polymenorrhoea
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0021 affected11 at risk
EG003
Alopecia areata
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0020 affected11 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected19 at risk
EG0021 affected11 at risk
EG003
Skin lesion inflammation
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected19 at risk
EG0020 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected19 at risk
EG0020 affected11 at risk
EG003
Amendment 02 of the Clinical Protocol (18 April 2018) modified the study design, so that the Double-Blind Period (DB) would not include anymore 2 consecutive periods (DB1 and DB2). However, for transparency and completeness reasons, in the Participant Flow and Adverse Events sections data about DB1 and DB2 are reported separately.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D005921
Glomerulonephritis
D009393
Nephritis
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069594
Abatacept
D000077330
Saline Solution
D005947
Glucose
D014867
Water
Ancestor Terms
ID
Term
D018796
Immunoconjugates
D000906
Antibodies
D007136
Immunoglobulins
D012712
Serum Globulins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D005916
Globulins
D000077324
Crystalloid Solutions
D007552
Isotonic Solutions
D012996
Solutions
D004364
Pharmaceutical Preparations
D006601
Hexoses
D009005
Monosaccharides
D000073893
Sugars
D002241
Carbohydrates
D006878
Hydroxides
D000468
Alkalies
D007287
Inorganic Chemicals
D000838
Anions
D007477
Ions
D004573
Electrolytes
D010087
Oxides
D017601
Oxygen Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
No longer meeting study criteria
FG0001 subjects
FG0010 subjects
Lack of Efficacy
FG0001 subjects
FG0012 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
0 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
Lack of Efficacy
FG0003 subjects
FG0015 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
20
Male
BG0009
BG0017
BG00216
7
Not Hispanic or Latino
BG00015
BG00114
BG00229
Unknown or Not Reported
BG0000
BG0010
BG0020
0
Asian
BG0000
BG0010
BG0020
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
Black or African American
BG0004
BG0013
BG0027
White
BG00013
BG00114
BG00227
More than one race
BG0000
BG0010
BG0020
Unknown or Not Reported
BG0000
BG0012
BG0022
OG0017.7(0.2 to 36.0)
Open Label Period Day 113
ParticipantsOG0008
ParticipantsOG0019
Title
Measurements
OG00012.5(0.3 to 52.7)
OG00133.3(7.5 to 70.1)
Mean Difference (Final Values)
-20.8
2-Sided
95
-63.3
24.3
Abatacept - Placebo for Open Label Period Day 113
Superiority
17
OG00119
Title
Denominators
Categories
Double-Blind Period Day 113
ParticipantsOG00013
ParticipantsOG00113
Title
Measurements
OG0000.12± 0.5738
OG001-0.25± 0.7914
Open Label Period Day 113
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG0001.98± 1.1598
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Final Values)
0.37
2-Sided
95
-1.6495
2.3855
Abatacept - Placebo for Double-Blind Period Day 113
Superiority
OG000
OG001
Mean Difference (Final Values)
1.95
2-Sided
95
-1.7933
5.6954
Abatacept - Placebo for Open Label Period Day 113
Superiority
17
OG00119
Title
Denominators
Categories
Double-Blind Period Day 113
ParticipantsOG00011
ParticipantsOG00112
Title
Measurements
OG0000.08± 0.1016
OG001-0.05± 0.0892
Open Label Period Day 113
ParticipantsOG0009
ParticipantsOG0019
Title
Measurements
OG0000.21± 0.1829
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Final Values)
0.13
2-Sided
95
-0.1483
0.4119
Abatacept - Placebo for Double-Blind Period Day 113
Superiority
OG000
OG001
Mean Difference (Final Values)
0.12
2-Sided
95
-0.5107
0.7551
Abatacept - Placebo for Open Label Period Day 113
Superiority
Participants
OG00017
OG00119
Title
Denominators
Categories
Double-Blind Period Day 113
ParticipantsOG00013
ParticipantsOG00113
Title
Measurements
OG0000.0(0.0 to 24.7)
OG0010.0(0.0 to 24.7)
Open Label Period Day 113
ParticipantsOG0008
ParticipantsOG0019
Title
Measurements
OG00012.5(0.3 to 52.7)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Final Values)
1.4
2-Sided
95
-44.7
44.7
Abatacept - Placebo for Open Label Period Day 113
Superiority
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days
Units
Counts
Participants
OG0009
OG00111
Title
Denominators
Categories
Fatigue
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG000-5.56± 2.2907
OG001-4.87± 2.6125
Pain Interference
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG000-4.88± 2.6395
OG001
Physical Function
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG0000.78± 1.7350
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Final Values)
-0.69
2-Sided
95
-8.1395
6.7645
Abatacept - Placebo for Fatigue
Superiority
OG000
OG001
Mean Difference (Final Values)
-3.70
2-Sided
95
-13.9402
6.5402
Abatacept - Placebo for Pain interference
Superiority
OG000
OG001
Mean Difference (Final Values)
-1.00
2-Sided
95
-6.5736
4.5736
Abatacept - Placebo for Physical function
Superiority
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Open Label Period (OLE): Abatacept IV administered every 28 days