Trial Outcomes & Findings for Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients (NCT NCT01001832)
NCT ID: NCT01001832
Last Updated: 2014-02-06
Results Overview
The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have \>=20% fewer tender joints and \>=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug.
COMPLETED
PHASE2/PHASE3
118 participants
Day 169
2014-02-06
Participant Flow
Study started 8 December 2009; short-term period ended 25 February 2011; long-term period ended 26 October 2012.
171 participants were enrolled, 118 participants were randomized and treated in the short-term period.
Participant milestones
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug.
|
Intravenous (IV) Abatacept, 125 mg
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug.
|
|---|---|---|
|
Short-term Period
STARTED
|
59
|
59
|
|
Short-term Period
COMPLETED
|
57
|
56
|
|
Short-term Period
NOT COMPLETED
|
2
|
3
|
|
Long-term Period
STARTED
|
56
|
56
|
|
Long-term Period
COMPLETED
|
52
|
51
|
|
Long-term Period
NOT COMPLETED
|
4
|
5
|
|
Follow-up Period
STARTED
|
52
|
51
|
|
Follow-up Period
COMPLETED
|
34
|
30
|
|
Follow-up Period
NOT COMPLETED
|
18
|
21
|
Reasons for withdrawal
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug.
|
Intravenous (IV) Abatacept, 125 mg
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug.
|
|---|---|---|
|
Short-term Period
Adverse Event
|
2
|
3
|
|
Long-term Period
Adverse Event
|
2
|
1
|
|
Long-term Period
Withdrawal by Subject
|
1
|
0
|
|
Long-term Period
Lack of Efficacy
|
0
|
2
|
|
Long-term Period
Other
|
1
|
2
|
|
Follow-up Period
Withdrawal by Subject
|
1
|
0
|
|
Follow-up Period
Follow-up no longer required /protocol
|
15
|
20
|
|
Follow-up Period
Other
|
2
|
1
|
Baseline Characteristics
Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients
Baseline characteristics by cohort
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug.
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 Years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
55.2 Years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
55.6 Years
STANDARD_DEVIATION 12.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
58 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian (not Japanese)
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Duration of Disease
|
7.5 Years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
5.3 Years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
6.4 Years
STANDARD_DEVIATION 8.3 • n=27 Participants
|
|
Duration of Disease Category
<= 2 years
|
25 Participants
42.4 • n=93 Participants
|
30 Participants
50.8 • n=4 Participants
|
55 Participants
46.6 • n=27 Participants
|
|
Duration of Disease Category
>2 to <= 5 years
|
7 Participants
11.9 • n=93 Participants
|
11 Participants
18.6 • n=4 Participants
|
18 Participants
15.3 • n=27 Participants
|
|
Duration of Disease Category
>5 to <= 10 years
|
10 Participants
16.9 • n=93 Participants
|
6 Participants
10.2 • n=4 Participants
|
16 Participants
13.6 • n=27 Participants
|
|
Duration of Disease Category
>10 years
|
17 Participants
28.8 • n=93 Participants
|
12 Participants
20.3 • n=4 Participants
|
29 Participants
24.6 • n=27 Participants
|
|
Tender Joint Count
|
20.9 Number of joints
STANDARD_DEVIATION 9.3 • n=93 Participants
|
22.3 Number of joints
STANDARD_DEVIATION 9.9 • n=4 Participants
|
21.6 Number of joints
STANDARD_DEVIATION 9.6 • n=27 Participants
|
|
Swollen Joint Count
|
16.4 Number of joints
STANDARD_DEVIATION 7.0 • n=93 Participants
|
17.6 Number of joints
STANDARD_DEVIATION 7.2 • n=4 Participants
|
17.0 Number of joints
STANDARD_DEVIATION 7.1 • n=27 Participants
|
|
DAS28-CRP
|
5.62 Units on a scale
STANDARD_DEVIATION 0.84 • n=93 Participants
|
5.95 Units on a scale
STANDARD_DEVIATION 0.91 • n=4 Participants
|
5.79 Units on a scale
STANDARD_DEVIATION 0.89 • n=27 Participants
|
|
HAQ Score
|
1.28 Units on a scale
STANDARD_DEVIATION 0.690 • n=93 Participants
|
1.32 Units on a scale
STANDARD_DEVIATION 0.64 • n=4 Participants
|
1.30 Units on a scale
STANDARD_DEVIATION 0.66 • n=27 Participants
|
|
Methotrexate dose
|
7.3 mg/week
STANDARD_DEVIATION 1.0 • n=93 Participants
|
7.3 mg/week
STANDARD_DEVIATION 1.0 • n=4 Participants
|
7.3 mg/week
STANDARD_DEVIATION 0.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: Day 169Population: N= All randomized participants who received at least 1 dose of study medication and were analyzed. n=number of participants with ACR20 response at Day 169: 54, 49, respectively. n/N= percentage: 54/59; 49/59.
The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have \>=20% fewer tender joints and \>=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period
|
91.5 Percentage of participants
Interval 81.3 to 97.2
|
83.1 Percentage of participants
Interval 71.0 to 91.6
|
PRIMARY outcome
Timeframe: Day 533Population: m=Long term period participants who received at least one dose of drug and were ACR responders in short term period: ACR20= 49, 46; ACR50= 35, 34; ACR70= 20, 16. n=number of paticipants with sustained ACR response at Day 533. n/m = percentage
The ACR score indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score= a percentage. To qualify for a score of 20, 50 or 70 (ACR20, ACR50 or ACR70), the patient must have \>=20%, \>=50% or \>=70%, respectively, fewer tender joints and \>=20%, \>=50% or \>=70%, respectively, fewer swollen joints and show 20%, 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Treatment groups represent treatment received in the short term period. Percentage calculated as n/m with n=number of paticipants with sustained ACR response at Day 533; m= long term participants who received at least one dose of drug and were ACR responders in the short term period.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=49 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=46 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period
ACR 20 (n/m= 47/49; 45/46)
|
95.9 percentage of participants
Interval 86.0 to 99.5
|
97.8 percentage of participants
Interval 88.5 to 99.9
|
|
Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period
ACR 50 (n/m= 30/35; 32/34)
|
85.7 percentage of participants
Interval 69.7 to 95.2
|
94.1 percentage of participants
Interval 80.3 to 99.3
|
|
Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period
ACR 70 (n/m= 15/20; 15/16)
|
75.0 percentage of participants
Interval 50.9 to 91.3
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
PRIMARY outcome
Timeframe: Baseline to Day 533Population: Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period.
Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=52 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=51 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period
|
-0.71 units on a scale
Interval -0.87 to -0.55
|
-0.71 units on a scale
Interval -0.89 to -0.52
|
PRIMARY outcome
Timeframe: Day 533Population: N=number of participants treated with at least 1 dose of study drug and with HAQ data available. n=number of participants with HAQ response. n/N = 41/52 and 31/51 in SC and IV arms, respectively. Treatment groups represent treatment received in the short term period.
The Health Assessment Questionnaire (HAQ) disability index assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The higher the number the worse the outcome. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. HAQ response=reduction of at least 0.30 units in HAQ score from baseline. The percentage of participants with a reduction of at least 0.30 units in their HAQ score from baseline is presented. Baseline is Day 1 of the study or last non-missing pre-treatment value. Treatment groups represent treatment received in the short term period.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=52 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=51 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period
|
78.8 percentage of participants
Interval 65.3 to 88.9
|
60.8 percentage of participants
Interval 46.1 to 74.2
|
PRIMARY outcome
Timeframe: Baseline to Day 533Population: Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed.
The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS \>5.1 implies active disease; \<3.2, well controlled disease; and \<2.6, remission.). Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=52 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=51 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period
|
-3.27 units on a scale
Interval -3.58 to -2.97
|
-3.49 units on a scale
Interval -3.82 to -3.17
|
SECONDARY outcome
Timeframe: Day 169Population: m= All participants who received at least 1 dose of study medication in short term period and had data available. n= participants with ACR50 or ACR70 response in the short term period. n/m= percentage
The American College of Rheumatology (ACR) scores of 50 and 70 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score represents a percentage. To qualify for an ACR50 or ACR70 scores, the patient must have \>=50% or \>=70%, respectively, fewer tender joints and \>=50% or \>=70%, respectively, fewer swollen joints and show 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation).
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period
ACR50 (n/m=39/59, 37/59)
|
66.1 Percentage of participants
Interval 52.6 to 77.9
|
62.7 Percentage of participants
Interval 49.1 to 75.0
|
|
Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period
ACR70 (n/m=22/59, 18/59)
|
37.3 Percentage of participants
Interval 25.0 to 50.9
|
30.5 Percentage of participants
Interval 19.2 to 43.9
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All participants who received at least 1 dose of study medication were analyzed.
Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period
|
-0.62 Units on a scale
Interval -0.74 to -0.49
|
-0.61 Units on a scale
Interval -0.73 to -0.49
|
SECONDARY outcome
Timeframe: Day 169Population: N=All randomized participants who received at least 1 dose of study medication in short term period. n=number of participants with HAQ response in short term period; n/N=percentage of participants: 41/59 and 30/59
The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. The HAQ-DI response is defined as a reduction of at least 0.30 units in HAQ score from baseline.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Percentage of Participants With HAQ Response at Day 169 in the Short Term Period
|
69.5 Percentage of participants
Interval 56.1 to 80.8
|
50.8 Percentage of participants
Interval 37.5 to 64.1
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsPopulation: All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed.
The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS \>5.1 implies active disease; \<3.2, well controlled disease; and \<2.6, remission.). Baseline is Day 1 or last non-missing pre-treatment value.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants
|
-2.97 Units on a scale
Interval -3.25 to -2.7
|
-2.75 Units on a scale
Interval -3.03 to -2.48
|
SECONDARY outcome
Timeframe: Day 169Population: m=All randomized participants who received at least 1 dose of study medication and with LDAS and REM data available. n= number of participants with LDAS and REM. n/m=percentage of participants.
EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (\<) 2.6.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=57 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=57 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period
LDAS (n/m= 40/57, 38/57)
|
70.2 Percentage of participants
Interval 56.6 to 81.6
|
66.7 Percentage of participants
Interval 52.9 to 78.6
|
|
Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period
REM (n/m= 29/57, 23/57)
|
50.9 Percentage of participants
Interval 37.3 to 64.4
|
40.4 Percentage of participants
Interval 27.6 to 54.2
|
SECONDARY outcome
Timeframe: Day 533Population: m=All treated participants in the long term period in the analysis with available LDAS and REM data. n=number of participants with either EULAR-defined LDAS response or EULAR-defined REM response. n/m = percentage of participants
EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP\<2.6.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=52 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=51 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period
REM (n/m= 33/52; 32/51)
|
63.5 percentage of participants
Interval 49.0 to 76.4
|
62.7 percentage of participants
Interval 48.1 to 75.9
|
|
Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period
LDAS (n/m= 45/52, 42/51)
|
86.5 percentage of participants
Interval 74.2 to 94.4
|
82.4 percentage of participants
Interval 69.1 to 91.6
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All randomized participants who received at least 1 dose of study medication.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
AEs
|
45 Participants
|
49 Participants
|
|
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Discontinuations due to AEs
|
3 Participants
|
3 Participants
|
|
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Deaths
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
SAEs
|
4 Participants
|
3 Participants
|
|
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Treatment-related SAEs
|
3 Participants
|
2 Participants
|
|
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Discontinuations due to SAEs
|
3 Participants
|
1 Participants
|
|
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Treatment-related AEs
|
31 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 533 and up to 56 days following last dose in Long-Term periodPopulation: All randomized participants who received at least 1 dose of study medication.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
SAEs
|
5 Participants
|
5 Participants
|
|
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Treatment-related SAEs
|
4 Participants
|
3 Participants
|
|
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Deaths
|
1 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Discontinuation due to SAEs
|
1 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
AEs
|
49 Participants
|
49 Participants
|
|
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Treatment-related AEs
|
31 Participants
|
32 Participants
|
|
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
Discontinuation due to AEs
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All randomized participants who received at least 1 dose of study medication.
lower limit of normal(LLN); upper limit of normal(ULN); pretreatment(preRX). Hemoglobin (g/dL): \>3 g/dL decrease from preRX; hematocrit (%): \<0.75\*preRX; erythrocytes (\*10\^6 c/uL): \<0.75\*preRX; platelet count (\*10\^9 c/uL): \<0.67\*LLN or \>1.5\*ULN, of if preRX\<LLN, use 0.5\*preRX and \<100,000/mm\^3; leukocytes (\*10\^3 c/uL): \<0.75\*LLN or \>1.25\*ULN, or if preRX \<LLN, use \<0.8\*preRX or \>ULN, or if preRX\>ULN, use \>1.2\*preRX or \<LLN; neutrophils+bands (\*10\^3 c/uL): if value \<1.0\*10\^3 c/uL; eosinophils (\*10\^3 c/uL): if value \>0.750\*10\^3 c/uL; basophils (\*10\^3 c/uL): if value \>400/mm\^3; monocytes (\*10\^3 c/uL): if value \>2000/mm\^3; lymphocytes (\*10\^3 c/uL): if value \<0.750\*10\^3 c/uL or if value \>7.50\*10\^3 c/uL.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Neutrophils + bands (absolute), low
|
1 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hemoglobin, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hemoglobin, high
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hematocrit, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hematocrit, high
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Erythrocytes, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Erythrocytes, high
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Platelet count, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Platelet count, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Leukocytes, low
|
1 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Leukocytes, high
|
2 Participants
|
3 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Neutrophils + bands (absolute), high
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Eosinophils (absolute), low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Eosinophils (absolute), high
|
1 Participants
|
2 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Basophils (absolute), low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Basophils (absolute), high
|
1 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Monocytes (absolute), low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Monocytes (absolute), high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Lymphocytes (absolute), low
|
8 Participants
|
10 Participants
|
|
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Lymphocytes (absolute), high
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 533Population: All randomized participants who received at least 1 dose of study medication.
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): \>3 g/dL decrease from preRX; hematocrit (%): \<0.75\*preRX; erythrocytes (\*10\^6 c/uL): \<0.75\*preRX; platelet count (\*10\^9 c/uL): \<0.67\*LLN or \>1.5\*ULN, of if preRX\<LLN, use 0.5\*preRX and \<100,000/mm\^3; leukocytes (\*10\^3 c/uL): \<0.75\*LLN or \>1.25\*ULN, or if preRX \<LLN, use \<0.8\*preRX or \>ULN, or if preRX\>ULN, use \>1.2\*preRX or \<LLN; neutrophils+bands (\*10\^3 c/uL): if value \<1.0\*10\^3 c/uL; eosinophils (\*10\^3 c/uL): if value \>0.750\*10\^3 c/uL; basophils (\*10\^3 c/uL): if value \>400/mm\^3; monocytes (\*10\^3 c/uL): if value \>2000/mm\^3; lymphocytes (\*10\^3 c/uL): if value \<0.750\*10\^3 c/uL or if value \>7.50\*10\^3 c/uL.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Hemoglobin, low
|
0 Participants
|
1 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Hemoglobin, high
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Hematocrit, low
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Hematocrit, high
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Erythrocytes, low
|
0 Participants
|
2 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Erythrocytes, high
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Platelet count, low
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Platelet count, high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Leukocytes, low
|
0 Participants
|
2 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Leukocytes, high
|
0 Participants
|
1 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Neutrophils + bands (absolute), low
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Neutrophils + bands (absolute), high
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Eosinophils (absolute), low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Eosinophils (absolute), high
|
1 Participants
|
2 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Basophils (absolute), low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Basophils (absolute), high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Monocytes (absolute), low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Monocytes (absolute), high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Lymphocytes (absolute), low
|
11 Participants
|
8 Participants
|
|
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Lymphocytes (absolute), high
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All randomized participants who received at least 1 dose of study medication.
ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. alkaline phosphatase (ALP) (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; aspartate aminotransferase (AST) (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; alanine aminotransferase(ALT) (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; Gamma glutamyltransferase(GGT) (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; bilirubin (mg/dL): \>2\*ULN, or if preRX\>ULN, use \>4\*preRX; blood urea nitrogen (mg/dL): \>2\*preRX; creatinine (mg/dL): \>1.5\*preRX.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Alkaline phosphatase (ALP), low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
ALP, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Aspartate aminotransferase (AST), low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
AST, high
|
0 Participants
|
1 Participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Alanine aminotransferase (ALT), low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
ALT, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
G-glutamyl transferase (GGT), low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
GGT, high
|
1 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Bilirubin, total, low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Bilirubin, total, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Blood urea nitrogen, low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Blood urea nitrogen, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Creatinine, low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Creatinine, high
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All randomized participants who received at least 1 dose of study medication.
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): \<0.95\*LLN or \>1.05\*ULN, or if preRX\<LLN, use \<0.95\*preRX or \>ULN, or if preRX\>ULN, use 1.05\*preRX or \<LLN; potassium (mEq/L): \<0.9\*LLN or \>1.1\*ULN, or if preRX\<LLN, use \<0.9\*preRX or \>ULN, or if preRX\>ULN, use 1.1\*preRX or \<LLN; chloride (mEq/L): \<0.75\*LLN or \>1.125\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; calcium (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; phosphorus (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.67\*preRX or \>ULN, or if preRX\>ULN, use 1.33\*preRX or \<LLN.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=59 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Sodium, serum, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Sodium, serum, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Potassium, serum, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Potassium, serum, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Chloride, serum, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Chloride, serum, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Calcium, total, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Calcium, total, high
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Phosphorus, inorganic, low
|
0 Participants
|
0 Participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Phosphorus, inorganic, high
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 533Population: All randomized participants who received at least 1 dose of study medication.
ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. ALP (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; AST (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; ALT (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; GGT (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; bilirubin (mg/dL): \>2\*ULN, or if preRX\>ULN, use \>4\*preRX; blood urea nitrogen (mg/dL): \>2\*preRX; creatinine (mg/dL): \>1.5\*preRX.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Creatinine, low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Alkaline phosphatase (ALP), low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
ALP, high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Aspartate aminotransferase (AST), low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
AST, high
|
0 Participants
|
2 Participants
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Alanine aminotransferase (ALT), low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
ALT, high
|
0 Participants
|
1 Participants
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
G-glutamyl transferase (GGT), low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
GGT, high
|
1 Participants
|
2 Participants
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Bilirubin, total, low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Bilirubin, total, high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Blood urea nitrogen, low
|
NA Participants
Not evaluated.
|
NA Participants
Not evaluated.
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Blood urea nitrogen, high
|
1 Participants
|
1 Participants
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Creatinine, high
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 533Population: All randomized participants who received at least 1 dose of study medication.
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): \<0.95\*LLN or \>1.05\*ULN, or if preRX\<LLN, use \<0.95\*preRX or \>ULN, or if preRX\>ULN, use 1.05\*preRX or \<LLN; potassium (mEq/L): \<0.9\*LLN or \>1.1\*ULN, or if preRX\<LLN, use \<0.9\*preRX or \>ULN, or if preRX\>ULN, use 1.1\*preRX or \<LLN; chloride (mEq/L): \<0.75\*LLN or \>1.125\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; calcium (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; phosphorus (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.67\*preRX or \>ULN, or if preRX\>ULN, use 1.33\*preRX or \<LLN.
Outcome measures
| Measure |
Subcutaneous (SC) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
Intravenous (IV) Abatacept, 125 mg
n=56 Participants
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
|
|---|---|---|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Sodium, serum, low
|
1 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Sodium, serum, high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Potassium, serum, low
|
0 Participants
|
2 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Potassium, serum, high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Chloride, serum, low
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Chloride, serum, high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Calcium, total, low
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Calcium, total, high
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Phosphorus, inorganic, low
|
0 Participants
|
0 Participants
|
|
Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Phosphorus, inorganic, high
|
0 Participants
|
1 Participants
|
Adverse Events
Abatacept Long-term (LT) SC 125 mg
Short Term Intravenous (IV) Abatacept, 125 mg
Short Term Subcutaneous (SC) Abatacept, 125 mg
Serious adverse events
| Measure |
Abatacept Long-term (LT) SC 125 mg
n=112 participants at risk
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo). Follow-up was up to 168 days after the last dose of drug.
|
Short Term Intravenous (IV) Abatacept, 125 mg
n=59 participants at risk
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
|
Short Term Subcutaneous (SC) Abatacept, 125 mg
n=59 participants at risk
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/112 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
General disorders
Medical device complication
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Infections and infestations
Pneumonia bacterial
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
General disorders
Pyrexia
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Eye disorders
Cataract
|
1.8%
2/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Colonic polyp
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Infections and infestations
Dacryocystitis
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Infections and infestations
Pneumonia
|
0.00%
0/112 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/112 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
Other adverse events
| Measure |
Abatacept Long-term (LT) SC 125 mg
n=112 participants at risk
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo). Follow-up was up to 168 days after the last dose of drug.
|
Short Term Intravenous (IV) Abatacept, 125 mg
n=59 participants at risk
Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
|
Short Term Subcutaneous (SC) Abatacept, 125 mg
n=59 participants at risk
Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
8.0%
9/112 • Day 1 to 6 months post last dose
|
6.8%
4/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Constipation
|
1.8%
2/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
6.8%
4/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Periodontitis
|
3.6%
4/112 • Day 1 to 6 months post last dose
|
6.8%
4/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.7%
3/112 • Day 1 to 6 months post last dose
|
5.1%
3/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
8/112 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
32/112 • Day 1 to 6 months post last dose
|
27.1%
16/59 • Day 1 to 6 months post last dose
|
15.3%
9/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/112 • Day 1 to 6 months post last dose
|
6.8%
4/59 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
3/112 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
5.1%
3/59 • Day 1 to 6 months post last dose
|
|
Vascular disorders
Hypertension
|
5.4%
6/112 • Day 1 to 6 months post last dose
|
6.8%
4/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Nausea
|
5.4%
6/112 • Day 1 to 6 months post last dose
|
3.4%
2/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
2/112 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
8.5%
5/59 • Day 1 to 6 months post last dose
|
|
Infections and infestations
Gastroenteritis
|
6.2%
7/112 • Day 1 to 6 months post last dose
|
0.00%
0/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Infections and infestations
Pharyngitis
|
5.4%
6/112 • Day 1 to 6 months post last dose
|
10.2%
6/59 • Day 1 to 6 months post last dose
|
1.7%
1/59 • Day 1 to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.89%
1/112 • Day 1 to 6 months post last dose
|
5.1%
3/59 • Day 1 to 6 months post last dose
|
3.4%
2/59 • Day 1 to 6 months post last dose
|
|
Gastrointestinal disorders
Stomatitis
|
16.1%
18/112 • Day 1 to 6 months post last dose
|
13.6%
8/59 • Day 1 to 6 months post last dose
|
11.9%
7/59 • Day 1 to 6 months post last dose
|
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