Trial Outcomes & Findings for Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis (NCT NCT02557100)
NCT ID: NCT02557100
Last Updated: 2020-09-03
Results Overview
Percentage of participants who experienced an AE
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
up to 85 days post last dose, approximately 40 weeks
Results posted on
2020-09-03
Participant Flow
80 participants randomized and treated.
Participant milestones
| Measure |
Treatment A
Abatacept Single Blind Treatment Period
|
Treatment B
Adalimumab Single Blind Treatment Period
|
Treatment C
Cumulative Abatacept Period
|
|---|---|---|---|
|
Single Blind Treatment Period
STARTED
|
40
|
40
|
0
|
|
Single Blind Treatment Period
COMPLETED
|
40
|
36
|
0
|
|
Single Blind Treatment Period
NOT COMPLETED
|
0
|
4
|
0
|
|
Transition to Open Label
STARTED
|
40
|
36
|
0
|
|
Transition to Open Label
COMPLETED
|
0
|
0
|
0
|
|
Transition to Open Label
NOT COMPLETED
|
40
|
36
|
0
|
|
Cumulative Abatacept Period
STARTED
|
0
|
0
|
76
|
|
Cumulative Abatacept Period
COMPLETED
|
0
|
0
|
72
|
|
Cumulative Abatacept Period
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Treatment A
Abatacept Single Blind Treatment Period
|
Treatment B
Adalimumab Single Blind Treatment Period
|
Treatment C
Cumulative Abatacept Period
|
|---|---|---|---|
|
Single Blind Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Single Blind Treatment Period
Death
|
0
|
1
|
0
|
|
Single Blind Treatment Period
Request to Discontinue
|
0
|
1
|
0
|
|
Single Blind Treatment Period
Adverse Event
|
0
|
1
|
0
|
|
Transition to Open Label
Entered Cumulative Abatacept Period
|
40
|
36
|
0
|
|
Cumulative Abatacept Period
Other Reasons
|
0
|
0
|
1
|
|
Cumulative Abatacept Period
Lost to Follow-up
|
0
|
0
|
2
|
|
Cumulative Abatacept Period
Request to Discontinue
|
0
|
0
|
1
|
Baseline Characteristics
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
Cumulative Abatacept Period
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.2 Years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
44.7 Years
STANDARD_DEVIATION 16.30 • n=7 Participants
|
—
|
46.0 Years
STANDARD_DEVIATION 14.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
—
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
—
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
—
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
—
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
—
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 85 days post last dose, approximately 40 weeksPopulation: All Treated Participants
Percentage of participants who experienced an AE
Outcome measures
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 Participants
Cumulative Abatacept Period
|
|---|---|---|---|
|
Percentage of Adverse Events (AEs)
|
55.0 Percentage of participant with AEs
|
70.0 Percentage of participant with AEs
|
57.9 Percentage of participant with AEs
|
PRIMARY outcome
Timeframe: up to 85 days post last dose, approximately 40 weeksPopulation: All treated participants
Percentage of participants who experienced an SAEs
Outcome measures
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 Participants
Cumulative Abatacept Period
|
|---|---|---|---|
|
Percentage of Participants With an Serious Adverse Events (SAEs)
|
2.5 Percentage of participants with SAEs
|
5.0 Percentage of participants with SAEs
|
5.3 Percentage of participants with SAEs
|
PRIMARY outcome
Timeframe: up to 85 days post last dose, approximately 40 weeksPopulation: All Treated Participants
Percentage of participants who experienced an (AEsDc)
Outcome measures
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 Participants
Cumulative Abatacept Period
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
|
0 Percentage of participants with AEsDC
|
2.5 Percentage of participants with AEsDC
|
0 Percentage of participants with AEsDC
|
PRIMARY outcome
Timeframe: up to 85 days post last dose, approximately 40 weeksPopulation: All Treated Participants
Percentage of participants who experienced an (SAEsDc)
Outcome measures
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 Participants
Cumulative Abatacept Period
|
|---|---|---|---|
|
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
|
0 Percentage of participants with SAEsDc
|
2.5 Percentage of participants with SAEsDc
|
0 Percentage of participants with SAEsDc
|
PRIMARY outcome
Timeframe: up to 85 days post last dose, approximately 40 weeksPopulation: All Treated Participants
Percentage of participants who experienced an DRAEs
Outcome measures
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 Participants
Cumulative Abatacept Period
|
|---|---|---|---|
|
Percentage of Drug Related Adverse Events (DRAEs)
|
30.0 Percentage of participants with DRAEs
|
27.5 Percentage of participants with DRAEs
|
22.4 Percentage of participants with DRAEs
|
PRIMARY outcome
Timeframe: up to 85 days post last dose, approximately 40 weeksPopulation: All Treated Participants
Percentage of participants who experienced an DRSAEs
Outcome measures
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 Participants
Cumulative Abatacept Period
|
|---|---|---|---|
|
Percentage of Drug Related Serious Adverse Events (DRSAEs)
|
0 Percentage of Participants with DRSAEs
|
2.5 Percentage of Participants with DRSAEs
|
0 Percentage of Participants with DRSAEs
|
PRIMARY outcome
Timeframe: up to 85 days post last dose, approximately 40 weeksPopulation: All Treated Participants
Number of participants who experienced Death
Outcome measures
| Measure |
Treatment A
n=40 Participants
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 Participants
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 Participants
Cumulative Abatacept Period
|
|---|---|---|---|
|
Number of Deaths
|
0 Number of Deaths
|
1 Number of Deaths
|
0 Number of Deaths
|
Adverse Events
Treatment A
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Treatment B
Serious events: 2 serious events
Other events: 28 other events
Deaths: 1 deaths
Treatment C
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A
n=40 participants at risk
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 participants at risk
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 participants at risk
Cumulative Abatacept Period
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
2.5%
1/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
1.3%
1/76 • up to 85 days post last dose, approximately 40 weeks
|
|
General disorders
Sudden Death
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
2.5%
1/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Infections and infestations
Varicella
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
2.5%
1/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Nervous system disorders
Cerebral Infarction
|
2.5%
1/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
1.3%
1/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
1.3%
1/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
1.3%
1/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
1.3%
1/76 • up to 85 days post last dose, approximately 40 weeks
|
Other adverse events
| Measure |
Treatment A
n=40 participants at risk
Abatacept Single Blind Treatment Period
|
Treatment B
n=40 participants at risk
Adalimumab Single Blind Treatment Period
|
Treatment C
n=76 participants at risk
Cumulative Abatacept Period
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40 • up to 85 days post last dose, approximately 40 weeks
|
35.0%
14/40 • up to 85 days post last dose, approximately 40 weeks
|
13.2%
10/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
4/40 • up to 85 days post last dose, approximately 40 weeks
|
5.0%
2/40 • up to 85 days post last dose, approximately 40 weeks
|
6.6%
5/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
4/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
6.6%
5/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
7.5%
3/40 • up to 85 days post last dose, approximately 40 weeks
|
15.0%
6/40 • up to 85 days post last dose, approximately 40 weeks
|
11.8%
9/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.0%
2/40 • up to 85 days post last dose, approximately 40 weeks
|
12.5%
5/40 • up to 85 days post last dose, approximately 40 weeks
|
9.2%
7/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
2/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
2.6%
2/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • up to 85 days post last dose, approximately 40 weeks
|
5.0%
2/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
1/40 • up to 85 days post last dose, approximately 40 weeks
|
7.5%
3/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
5.0%
2/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/76 • up to 85 days post last dose, approximately 40 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/40 • up to 85 days post last dose, approximately 40 weeks
|
5.0%
2/40 • up to 85 days post last dose, approximately 40 weeks
|
0.00%
0/76 • up to 85 days post last dose, approximately 40 weeks
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60