Trial Outcomes & Findings for A Study of Abatacept in Patients With Active Crohn's Disease (NCT NCT00406653)
NCT ID: NCT00406653
Last Updated: 2010-09-14
Results Overview
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
TERMINATED
PHASE3
451 participants
At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).
2010-09-14
Participant Flow
Participant milestones
| Measure |
Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP)
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of \~10 mg/kg (weight-tiered).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
ABA ~10 mg/kg, Maintenance Period (MP)
During MP, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
|
Placebo, MP
During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
|
ABA ~10 mg/kg, Open-Label Period (OL)
During OL, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
|
|---|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
65
|
128
|
130
|
128
|
0
|
0
|
0
|
|
Induction Period
COMPLETED
|
50
|
94
|
112
|
102
|
0
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
15
|
34
|
18
|
26
|
0
|
0
|
0
|
|
Maintenance Period
STARTED
|
0
|
0
|
0
|
0
|
44
|
46
|
0
|
|
Maintenance Period
COMPLETED
|
0
|
0
|
0
|
0
|
14
|
10
|
0
|
|
Maintenance Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
30
|
36
|
0
|
|
Open-Label Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
324
|
|
Open-Label Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
324
|
Reasons for withdrawal
| Measure |
Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP)
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of \~10 mg/kg (weight-tiered).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
ABA ~10 mg/kg, Maintenance Period (MP)
During MP, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
|
Placebo, MP
During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
|
ABA ~10 mg/kg, Open-Label Period (OL)
During OL, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
|
|---|---|---|---|---|---|---|---|
|
Induction Period
Adverse Event
|
1
|
10
|
4
|
11
|
0
|
0
|
0
|
|
Induction Period
Lack of Efficacy
|
11
|
14
|
8
|
10
|
0
|
0
|
0
|
|
Induction Period
Lost to Follow-up
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Withdrawal of Consent
|
2
|
5
|
1
|
2
|
0
|
0
|
0
|
|
Induction Period
Subject No Longer Meets Study Criteria
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Induction Period
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Declined participation but followup done
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Induction Period
Given prohibited drug
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Induction Period
Incarcerated
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period
Patient relocated
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Maintenance Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
20
|
26
|
0
|
|
Maintenance Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Maintenance Period
Withdrawal of Consent
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Maintenance Period
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Period
Administrative Reason By Sponsor
|
0
|
0
|
0
|
0
|
4
|
7
|
0
|
|
Maintenance Period
Error in disease score evaluation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-Label Period
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
|
Open-Label Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
160
|
|
Open-Label Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Open-Label Period
Withdrawal of Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Open-Label Period
Subject No Longer Meets Study Criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Period
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Open-Label Period
Administrative Reason By Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
115
|
|
Open-Label Period
Declined participation but followup done
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
|
Open-Label Period
Discontinued by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Period
Refused followup
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Abatacept in Patients With Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
ABA 30/~10 mg/kg, Induction Period (IP)
n=65 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=128 Participants
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of \~10 mg/kg (weight-tiered).
|
ABA 3 mg/kg, IP
n=130 Participants
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
|
Placebo, IP
n=128 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
36.0 years
STANDARD_DEVIATION 11.12 • n=93 Participants
|
38.6 years
STANDARD_DEVIATION 12.90 • n=4 Participants
|
36.9 years
STANDARD_DEVIATION 13.35 • n=27 Participants
|
38.0 years
STANDARD_DEVIATION 12.98 • n=483 Participants
|
37.6 years
STANDARD_DEVIATION 12.81 • n=36 Participants
|
|
Age, Customized
<30 years
|
23 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
152 Participants
n=36 Participants
|
|
Age, Customized
Between 30 and 50 years
|
35 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
220 Participants
n=36 Participants
|
|
Age, Customized
>50 years
|
7 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
79 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
83 Participants
n=483 Participants
|
277 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
174 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
45 participants
n=4 Participants
|
46 participants
n=27 Participants
|
38 participants
n=483 Participants
|
153 participants
n=36 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
15 participants
n=36 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
3 participants
n=27 Participants
|
1 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Region of Enrollment
India
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
8 participants
n=36 Participants
|
|
Region of Enrollment
France
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
7 participants
n=27 Participants
|
7 participants
n=483 Participants
|
28 participants
n=36 Participants
|
|
Region of Enrollment
Czech Republic
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
5 participants
n=36 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=93 Participants
|
4 participants
n=4 Participants
|
0 participants
n=27 Participants
|
3 participants
n=483 Participants
|
8 participants
n=36 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
3 participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=93 Participants
|
18 participants
n=4 Participants
|
22 participants
n=27 Participants
|
27 participants
n=483 Participants
|
75 participants
n=36 Participants
|
|
Region of Enrollment
Brazil
|
3 participants
n=93 Participants
|
7 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
22 participants
n=36 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=93 Participants
|
7 participants
n=4 Participants
|
9 participants
n=27 Participants
|
13 participants
n=483 Participants
|
31 participants
n=36 Participants
|
|
Region of Enrollment
Korea, Democratic People's Republic of
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
4 participants
n=36 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=93 Participants
|
4 participants
n=4 Participants
|
10 participants
n=27 Participants
|
2 participants
n=483 Participants
|
17 participants
n=36 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=93 Participants
|
10 participants
n=4 Participants
|
13 participants
n=27 Participants
|
13 participants
n=483 Participants
|
42 participants
n=36 Participants
|
|
Region of Enrollment
South Africa
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
13 participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
3 participants
n=483 Participants
|
7 participants
n=36 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
1 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Inadequate Response/Intolerance to Prior Anti-Tumor Necrosis Factor (TNF) Agent Therapy
Inadequate Response/Intolerance To Prior Agents
|
42 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
282 Participants
n=36 Participants
|
|
Inadequate Response/Intolerance to Prior Anti-Tumor Necrosis Factor (TNF) Agent Therapy
No Inadequate Response/Intolerance To Prior Agents
|
23 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
169 Participants
n=36 Participants
|
|
Crohn's Disease (CD) Duration
|
8.4 Years
STANDARD_DEVIATION 7.49 • n=93 Participants
|
9.9 Years
STANDARD_DEVIATION 8.74 • n=4 Participants
|
9.2 Years
STANDARD_DEVIATION 7.98 • n=27 Participants
|
9.8 Years
STANDARD_DEVIATION 8.29 • n=483 Participants
|
9.5 Years
STANDARD_DEVIATION 8.21 • n=36 Participants
|
|
Crohn's Disease Activity Index (CDAI)
|
320.6 points
STANDARD_DEVIATION 61.59 • n=93 Participants
|
318.9 points
STANDARD_DEVIATION 65.08 • n=4 Participants
|
317.9 points
STANDARD_DEVIATION 59.87 • n=27 Participants
|
320.7 points
STANDARD_DEVIATION 72.09 • n=483 Participants
|
319.4 points
STANDARD_DEVIATION 65.03 • n=36 Participants
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
|
119.9 units on a scale
STANDARD_DEVIATION 26.22 • n=93 Participants
|
117.3 units on a scale
STANDARD_DEVIATION 30.60 • n=4 Participants
|
121.1 units on a scale
STANDARD_DEVIATION 28.0 • n=27 Participants
|
119.6 units on a scale
STANDARD_DEVIATION 31.17 • n=483 Participants
|
119.5 units on a scale
STANDARD_DEVIATION 29.36 • n=36 Participants
|
PRIMARY outcome
Timeframe: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).Population: All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=64 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=128 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=129 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=125 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85
|
11 participants
|
13 participants
|
20 participants
|
18 participants
|
PRIMARY outcome
Timeframe: Day MP-365 (12 months) of maintenance therapyPopulation: All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. The Maintenance Period was not sized based on power considerations, and thus, no formal statistical hypothesis testing was performed.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=42 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=45 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)
|
10 participants
|
5 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Between Day OL-1 and Day OL-617Population: All participants who received at least 1 infusion of open-label study medication at any time, based on a participant's received treatment (As Treated Analysis Population). The OL was not sized based on power considerations.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=324 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
AEs
|
267 participants
|
—
|
—
|
—
|
|
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Related AEs
|
128 participants
|
—
|
—
|
—
|
|
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Deaths
|
1 participants
|
—
|
—
|
—
|
|
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
SAEs
|
86 participants
|
—
|
—
|
—
|
|
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Related SAEs
|
21 participants
|
—
|
—
|
—
|
|
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Discontinuation due to AE
|
16 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Between Day OL-1 and Day OL-617Population: All participants who received at least 1 infusion of open-label study medication at any time, based on a participant's received treatment (As Treated Analysis Population)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=324 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
All Infections
|
144 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Serious Infections
|
13 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Opportunistic Infections (OI)-Total
|
2 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
OI-oral candidiasis
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
OI-gastroenteritis Cryptosporidial
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-Total
|
5 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-basal cell carcinoma
|
2 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-breast cancer
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-squamous cell carcinoma
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-chronic lymphocytic leukemia
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-Total
|
11 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-erythema nodosum
|
7 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-psoriasis
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-pernicious anemia
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-antiphospholipid syndrome
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-ankylosing spondylitis
|
1 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Acute Infusional AEs
|
10 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Peri-infusional AEs
|
24 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapyPopulation: All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=64 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=128 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=129 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=126 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)
|
5 participants
|
5 participants
|
6 participants
|
8 participants
|
SECONDARY outcome
Timeframe: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapyPopulation: All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=125 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=129 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=128 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=64 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship
|
18 participants
|
20 participants
|
13 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline, Day IP-85Population: All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period with both Baseline and post-Baseline measurements.
The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-Baseline - Baseline value.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=60 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=116 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=124 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=121 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)
|
0.79 units on a scale
Standard Deviation 3.974
|
11.10 units on a scale
Standard Deviation 2.858
|
7.53 units on a scale
Standard Deviation 2.765
|
13.4 units on a scale
Standard Deviation 2.798
|
SECONDARY outcome
Timeframe: Day IP-1 through Day IP-85Population: All participants who received at least 1 infusion of study medication during the Induction Period, based on a participant's received treatment (As Treated Analysis Population)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=65 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=128 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=130 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=128 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Related SAEs
|
2 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
|
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Discontinuation due to AE
|
1 Participants
|
11 Participants
|
5 Participants
|
12 Participants
|
|
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
AEs
|
49 Participants
|
97 Participants
|
96 Participants
|
95 Participants
|
|
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Related AEs
|
24 Participants
|
47 Participants
|
46 Participants
|
40 Participants
|
|
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
SAEs
|
11 Participants
|
22 Participants
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day IP-1 through Day IP-85Population: All participants who received at least 1 infusion of study medication during the IP, based on a participant's received treatment (As Treated Analysis Population)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=65 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=128 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=130 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=128 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
All Infections
|
13 participants
|
33 participants
|
31 participants
|
42 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Serious Infections
|
2 participants
|
9 participants
|
4 participants
|
3 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Opportunistic Infections
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-Total
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-squamous cell carcinoma
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Malignancies-breast cancer
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-Total
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-erythema
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Autoimmune Disorders-psoriasis
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Acute Infusional AEs
|
3 participants
|
3 participants
|
4 participants
|
5 participants
|
|
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Peri-infusional AEs
|
13 participants
|
22 participants
|
15 participants
|
16 participants
|
SECONDARY outcome
Timeframe: For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85); For participants treated in OL directly after IP: Day IP-1 to Day OL-1; For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)Population: All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.
A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition identified specific anti-ABA reactivity. Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig) category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=63 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=123 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=127 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)
Total
|
4 participants
|
7 participants
|
12 participants
|
—
|
|
IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)
CTLA4/Possibly Ig
|
1 participants
|
0 participants
|
6 participants
|
—
|
|
IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)
Ig and/or Ig Junction
|
3 participants
|
7 participants
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapyPopulation: Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=42 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=86 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=76 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=77 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)
|
9 participants
|
8 participants
|
2 participants
|
10 participants
|
SECONDARY outcome
Timeframe: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapyPopulation: Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=42 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=86 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=76 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=77 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF
|
3 participants
|
2 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapyPopulation: Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=77 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=76 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
n=86 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
n=42 Participants
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship
|
10 participants
|
2 participants
|
8 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Between Day IP-85 and Day MP-365Population: All participants who received at least 1 infusion of study medication during the Maintenance Period, based on a participant's received treatment (As Treated Analysis Population)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=44 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=46 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
Related SAEs
|
0 Participants
|
1 Participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
AEs
|
31 Participants
|
32 Participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
Related AEs
|
12 Participants
|
15 Participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
Deaths
|
0 Participants
|
0 Participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
SAEs
|
5 Participants
|
9 Participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
Discontinuation due to AE
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Between Day IP-85 and Day MP-365Population: All participants who received at least 1 infusion of study medication during the MP, based on a participant's received treatment (As Treated Analysis Population)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=44 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=46 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Autoimmune Disorders-Total
|
2 participants
|
1 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
All Infections
|
16 participants
|
18 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Serious Infections
|
1 participants
|
1 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Opportunistic Infections
|
0 participants
|
0 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Malignancies
|
0 participants
|
0 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Autoimmune Disorders-psoriasis
|
2 participants
|
0 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Autoimmune Disorders-erythema
|
0 participants
|
1 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Acute Infusional AEs
|
1 participants
|
0 participants
|
—
|
—
|
|
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Peri-infusional AEs
|
2 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: For participants not entering OL: All measurements after Day MP-1 (including follow-up visits); For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1)Population: All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population. The placebo group was constituted by participants who received abatacept in the IP and underwent drug withdrawal in the MP.
A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=44 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=40 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
MP; Number of Participants With Positive Antibody Response to Abatacept
Total
|
7 participants
|
14 participants
|
—
|
—
|
|
MP; Number of Participants With Positive Antibody Response to Abatacept
CTLA4/Possibly Ig
|
2 participants
|
8 participants
|
—
|
—
|
|
MP; Number of Participants With Positive Antibody Response to Abatacept
Ig and/or Ig Junction
|
5 participants
|
8 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day MP-365Population: All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=42 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
n=45 Participants
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.
|
11 participants
|
7 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day MP-169Population: Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for the cohort of participants with clinical remission at both Day MP-169 and Day MP-365 was not conducted for the MP as planned.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day MP-365Population: Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day MP-365Population: Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.
The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-baseline - Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day MP-365Population: On/after Day MP-1, a recommended tapering of corticosteroids was planned if participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned
Participants who received corticosteroid therapy (e.g. prednisone or budesonide) were to maintain a stable dose until Day MP-1. On or after Day MP-1, a recommended tapering regimen of corticosteroid therapy was planned if the participant was in remission (i.e., CDAI score \< 150), or if the participant's condition had satisfactorily improved according to investigators clinical assessment. Other CD therapy was to remain at a stable dose throughout the Maintenance Period, with the exception of decreases due to drug-related toxicities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day MP-365Population: On/after Day MP-1, a defined tapering of corticosteroids was planned if the participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score is based partly on entries from participant's Diary (7 days before evaluation) which is kept while on study. CDAI scores range from 0 to \~600. Clinical response=CDAI reduction ≥100 or absolute CDAI \<150. Clinical remission=CDAI \<150. Moderate to severe disease=CDAI ≥220 and ≤450.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day MP-365Population: Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical response in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day MP-365Population: Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical remission in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between Day OL-1 and Day OL-617Population: Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of corticosteroid use in participants was not conducted for the OL as planned.
Background corticosteroid therapy included prednisone or budesonide.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day OL-169Population: All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=163 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169
Clinical Response
|
84 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169
Clinical Remission
|
55 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day OL-365Population: All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=69 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365
Clinical Response
|
35 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365
Clinical Remission
|
24 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)Population: All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.
A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
Outcome measures
| Measure |
ABA 30/~10 mg/kg, IP
n=314 Participants
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA ~10 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of \~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (weight-tiered; \~10 mg/kg group).
|
ABA 3 mg/kg, IP
During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
|
Placebo, IP
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
|---|---|---|---|---|
|
OL; Number of Participants With Positive Antibody Response to Abatacept
Total
|
71 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Positive Antibody Response to Abatacept
CTLA4/Possibly Ig
|
46 participants
|
—
|
—
|
—
|
|
OL; Number of Participants With Positive Antibody Response to Abatacept
Ig and/or Ig Junction
|
29 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Between Day OL-1 and Day OL-617Population: Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of pharmacogenomic marker activity in participants was not conducted for the OL as planned.
Changes in the expression of individual ribonucleic acid (RNA) transcripts were to be evaluated from whole blood using both microarray transcriptional profiling and quantitative polymerase chain reaction (PCR) methods. Peripheral RNA transcriptional profiling was to be used only to identify individual RNA transcripts that differ in expression with respect to time, treatment and outcome.
Outcome measures
Outcome data not reported
Adverse Events
ABA 30/~10mg/kg (IP)
ABA 3mg/kg (IP)
ABA ~10mg/kg (IP)
ABA ~10mg/kg (MP)
ABA ~10mg/kg (OL)
Placebo (IP)
Placebo (MP)
Serious adverse events
| Measure |
ABA 30/~10mg/kg (IP)
n=65 participants at risk
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA 3mg/kg (IP)
n=130 participants at risk
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
|
ABA ~10mg/kg (IP)
n=128 participants at risk
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of \~10 mg/kg (weight-tiered).
|
ABA ~10mg/kg (MP)
n=44 participants at risk
During MP, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
|
ABA ~10mg/kg (OL)
n=324 participants at risk
During OL, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
|
Placebo (IP)
n=128 participants at risk
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
Placebo (MP)
n=46 participants at risk
During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
EPISCLERITIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/65
|
0.00%
0/130
|
1.6%
2/128
|
0.00%
0/44
|
0.31%
1/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Psychiatric disorders
DEPRESSION
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Immune system disorders
TYPE I HYPERSENSITIVITY
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Immune system disorders
ANTIPHOSPHOLIPID SYNDROME
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Nervous system disorders
COMPLEX REGIONAL PAIN SYNDROME
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
2.2%
1/46
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
ACUTE ABDOMEN
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/65
|
1.5%
2/130
|
0.00%
0/128
|
2.3%
1/44
|
0.93%
3/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
ILEAL STENOSIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
7.7%
5/65
|
6.9%
9/130
|
7.0%
9/128
|
4.5%
2/44
|
10.8%
35/324
|
7.8%
10/128
|
6.5%
3/46
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/65
|
0.77%
1/130
|
0.78%
1/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
SMALL INTESTINAL STENOSIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
GASTROINTESTINAL DYSPLASIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
2.2%
1/46
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.5%
1/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.93%
3/324
|
0.00%
0/128
|
2.2%
1/46
|
|
Infections and infestations
ABSCESS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/65
|
0.77%
1/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
BRONCHITIS
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
2.3%
1/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/65
|
0.00%
0/130
|
1.6%
2/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/65
|
2.3%
3/130
|
3.1%
4/128
|
0.00%
0/44
|
0.93%
3/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
PELVIC ABSCESS
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
VULVAL ABSCESS
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
ACARODERMATITIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.93%
3/324
|
0.00%
0/128
|
2.2%
1/46
|
|
Renal and urinary disorders
URETHRAL CYST
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
2.3%
1/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
BURNS SECOND DEGREE
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
2.3%
1/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
THERAPEUTIC AGENT TOXICITY
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/65
|
0.77%
1/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/65
|
0.77%
1/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
General disorders
PYREXIA
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
General disorders
ASTHENIA
|
1.5%
1/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.00%
0/324
|
0.00%
0/128
|
0.00%
0/46
|
|
General disorders
CHEST PAIN
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.78%
1/128
|
2.2%
1/46
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/65
|
0.00%
0/130
|
0.78%
1/128
|
0.00%
0/44
|
0.00%
0/324
|
0.78%
1/128
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/65
|
0.77%
1/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.62%
2/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PITUITARY TUMOUR BENIGN
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
0.00%
0/65
|
0.00%
0/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/65
|
1.5%
2/130
|
0.00%
0/128
|
0.00%
0/44
|
0.31%
1/324
|
0.00%
0/128
|
0.00%
0/46
|
Other adverse events
| Measure |
ABA 30/~10mg/kg (IP)
n=65 participants at risk
During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of \~10 mg/kg (10 mg/kg group).
|
ABA 3mg/kg (IP)
n=130 participants at risk
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
|
ABA ~10mg/kg (IP)
n=128 participants at risk
During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of \~10 mg/kg (weight-tiered).
|
ABA ~10mg/kg (MP)
n=44 participants at risk
During MP, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
|
ABA ~10mg/kg (OL)
n=324 participants at risk
During OL, abatacept administered IV at a dose of \~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
|
Placebo (IP)
n=128 participants at risk
During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
|
Placebo (MP)
n=46 participants at risk
During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
10.8%
7/65
|
9.2%
12/130
|
10.2%
13/128
|
4.5%
2/44
|
9.3%
30/324
|
6.2%
8/128
|
6.5%
3/46
|
|
Nervous system disorders
DIZZINESS
|
6.2%
4/65
|
3.1%
4/130
|
2.3%
3/128
|
0.00%
0/44
|
0.93%
3/324
|
2.3%
3/128
|
2.2%
1/46
|
|
Gastrointestinal disorders
NAUSEA
|
9.2%
6/65
|
8.5%
11/130
|
7.0%
9/128
|
11.4%
5/44
|
10.8%
35/324
|
7.0%
9/128
|
4.3%
2/46
|
|
Gastrointestinal disorders
VOMITING
|
7.7%
5/65
|
2.3%
3/130
|
1.6%
2/128
|
6.8%
3/44
|
7.1%
23/324
|
6.2%
8/128
|
8.7%
4/46
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.2%
4/65
|
2.3%
3/130
|
5.5%
7/128
|
6.8%
3/44
|
8.0%
26/324
|
5.5%
7/128
|
6.5%
3/46
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
1.5%
1/65
|
0.77%
1/130
|
0.78%
1/128
|
6.8%
3/44
|
0.93%
3/324
|
0.00%
0/128
|
0.00%
0/46
|
|
Infections and infestations
INFLUENZA
|
1.5%
1/65
|
1.5%
2/130
|
2.3%
3/128
|
2.3%
1/44
|
4.0%
13/324
|
2.3%
3/128
|
6.5%
3/46
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/65
|
0.77%
1/130
|
1.6%
2/128
|
6.8%
3/44
|
1.9%
6/324
|
1.6%
2/128
|
0.00%
0/46
|
|
Infections and infestations
NASOPHARYNGITIS
|
1.5%
1/65
|
5.4%
7/130
|
1.6%
2/128
|
2.3%
1/44
|
7.7%
25/324
|
3.9%
5/128
|
8.7%
4/46
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.5%
1/65
|
4.6%
6/130
|
2.3%
3/128
|
2.3%
1/44
|
5.6%
18/324
|
5.5%
7/128
|
2.2%
1/46
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.5%
1/65
|
3.8%
5/130
|
0.00%
0/128
|
6.8%
3/44
|
7.7%
25/324
|
4.7%
6/128
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.2%
4/65
|
1.5%
2/130
|
0.78%
1/128
|
2.3%
1/44
|
3.1%
10/324
|
1.6%
2/128
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.8%
7/65
|
6.9%
9/130
|
5.5%
7/128
|
6.8%
3/44
|
8.3%
27/324
|
6.2%
8/128
|
6.5%
3/46
|
|
General disorders
FATIGUE
|
7.7%
5/65
|
6.2%
8/130
|
3.1%
4/128
|
6.8%
3/44
|
6.8%
22/324
|
7.8%
10/128
|
0.00%
0/46
|
|
General disorders
PYREXIA
|
13.8%
9/65
|
3.1%
4/130
|
3.9%
5/128
|
0.00%
0/44
|
6.5%
21/324
|
7.8%
10/128
|
8.7%
4/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER