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Trial record 34 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients

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ClinicalTrials.gov Identifier: NCT01001832
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : February 7, 2013
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Intravenous (IV) abatacept
Drug: Subcutaneous (SC) abatacept
Enrollment 118
Recruitment Details Study started 8 December 2009; short-term period ended 25 February 2011; long-term period ended 26 October 2012.
Pre-assignment Details 171 participants were enrolled, 118 participants were randomized and treated in the short-term period.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description

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.

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.

Period Title: Short-term Period
Started 59 59
Completed 57 56
Not Completed 2 3
Reason Not Completed
Adverse Event             2             3
Period Title: Long-term Period
Started 56 [1] 56
Completed 52 51
Not Completed 4 5
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             1             0
Lack of Efficacy             0             2
Not specified             1             2
[1]
1 participant completed the short term period but discontinued before start of the Long-term Period.
Period Title: Follow-up Period
Started 52 51
Completed 34 30
Not Completed 18 21
Reason Not Completed
Withdrawal by Subject             1             0
Follow-up no longer required /protocol             15             20
Not specified             2             1
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 59 59 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 59 participants 118 participants
56.1  (12.3) 55.2  (13.6) 55.6  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
Female
38
  64.4%
48
  81.4%
86
  72.9%
Male
21
  35.6%
11
  18.6%
32
  27.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
Japanese 58 59 117
Asian (not Japanese) 1 0 1
Duration of Disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 59 participants 118 participants
7.5  (9.2) 5.3  (7.3) 6.4  (8.3)
Duration of Disease Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
<= 2 years 25 30 55
>2 to <= 5 years 7 11 18
>5 to <= 10 years 10 6 16
>10 years 17 12 29
Tender Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of joints
Number Analyzed 59 participants 59 participants 118 participants
20.9  (9.3) 22.3  (9.9) 21.6  (9.6)
[1]
Measure Description: The number of joints the participant finds painful (tender) is counted by the investigator.
Swollen Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of joints
Number Analyzed 59 participants 59 participants 118 participants
16.4  (7.0) 17.6  (7.2) 17.0  (7.1)
[1]
Measure Description: the number of the participants' joints that the investigator observes is swollen.
DAS28-CRP   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 59 participants 59 participants 118 participants
5.62  (0.84) 5.95  (0.91) 5.79  (0.89)
[1]
Measure Description: 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). These measures are then fed into a complex mathematical formula to produce the overall DAS (greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
HAQ Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 59 participants 59 participants 118 participants
1.28  (0.690) 1.32  (0.64) 1.30  (0.66)
[1]
Measure Description: The Health Assessment Questionnaire(HAQ) Disability Index (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.
Methotrexate dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/week
Number Analyzed 59 participants 59 participants 118 participants
7.3  (1.0) 7.3  (1.0) 7.3  (0.9)
[1]
Measure Description: The methotrexate dose is the calculated weekly total dose in the week ending at the first dose date of the Short-term Period.
1.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period
Hide Description 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.
Time Frame Day 169
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Hide Analysis Population Description
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.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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).

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).

Overall Number of Participants Analyzed 59 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
91.5
(81.3 to 97.2)
83.1
(71.0 to 91.6)
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 49 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
ACR 20 (n/m= 47/49; 45/46)
95.9
(86.0 to 99.5)
97.8
(88.5 to 99.9)
ACR 50 (n/m= 30/35; 32/34)
85.7
(69.7 to 95.2)
94.1
(80.3 to 99.3)
ACR 70 (n/m= 15/20; 15/16)
75.0
(50.9 to 91.3)
93.8
(69.8 to 99.8)
3.Primary Outcome
Title Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period
Hide Description 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.
Time Frame Baseline to Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 52 51
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.71
(-0.87 to -0.55)
-0.71
(-0.89 to -0.52)
4.Primary Outcome
Title Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period
Hide Description 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.
Time Frame Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 52 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.8
(65.3 to 88.9)
60.8
(46.1 to 74.2)
5.Primary Outcome
Title Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period
Hide Description 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.
Time Frame Baseline to Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 52 51
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.27
(-3.58 to -2.97)
-3.49
(-3.82 to -3.17)
6.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
ACR50 (n/m=39/59, 37/59)
66.1
(52.6 to 77.9)
62.7
(49.1 to 75.0)
ACR70 (n/m=22/59, 18/59)
37.3
(25.0 to 50.9)
30.5
(19.2 to 43.9)
7.Secondary Outcome
Title Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period
Hide Description 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.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication were analyzed.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.62
(-0.74 to -0.49)
-0.61
(-0.73 to -0.49)
8.Secondary Outcome
Title Percentage of Participants With HAQ Response at Day 169 in the Short Term Period
Hide Description 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.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
69.5
(56.1 to 80.8)
50.8
(37.5 to 64.1)
9.Secondary Outcome
Title Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants
Hide Description 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.
Time Frame Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-2.97
(-3.25 to -2.70)
-2.75
(-3.03 to -2.48)
10.Secondary Outcome
Title 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
Hide Description EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (<) 2.6.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 57 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
LDAS (n/m= 40/57, 38/57)
70.2
(56.6 to 81.6)
66.7
(52.9 to 78.6)
REM (n/m= 29/57, 23/57)
50.9
(37.3 to 64.4)
40.4
(27.6 to 54.2)
11.Secondary Outcome
Title 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
Hide Description EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP<2.6.
Time Frame Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 52 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
LDAS (n/m= 45/52, 42/51)
86.5
(74.2 to 94.4)
82.4
(69.1 to 91.6)
REM (n/m= 33/52; 32/51)
63.5
(49.0 to 76.4)
62.7
(48.1 to 75.9)
12.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0
SAEs 4 3
Treatment-related SAEs 3 2
Discontinuations due to SAEs 3 1
AEs 45 49
Treatment-related AEs 31 35
Discontinuations due to AEs 3 3
13.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Day 533 and up to 56 days following last dose in Long-Term period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 56 56
Measure Type: Number
Unit of Measure: Participants
Deaths 1 0
SAEs 5 5
Treatment-related SAEs 4 3
Discontinuation due to SAEs 1 0
AEs 49 49
Treatment-related AEs 31 32
Discontinuation due to AEs 2 1
14.Secondary Outcome
Title Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description 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.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: Participants
Hemoglobin, low 0 0
Hemoglobin, high NA [1]  NA [1] 
Hematocrit, low 0 0
Hematocrit, high NA [1]  NA [1] 
Erythrocytes, low 0 0
Erythrocytes, high NA [1]  NA [1] 
Platelet count, low 0 0
Platelet count, high 0 0
Leukocytes, low 1 0
Leukocytes, high 2 3
Neutrophils + bands (absolute), low 1 0
Neutrophils + bands (absolute), high NA [1]  NA [1] 
Eosinophils (absolute), low NA [1]  NA [1] 
Eosinophils (absolute), high 1 2
Basophils (absolute), low NA [1]  NA [1] 
Basophils (absolute), high 1 0
Monocytes (absolute), low NA [1]  NA [1] 
Monocytes (absolute), high 0 0
Lymphocytes (absolute), low 8 10
Lymphocytes (absolute), high 0 0
[1]
Not evaluated
15.Secondary Outcome
Title Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
Hide Description 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.
Time Frame Baseline to Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 56 56
Measure Type: Number
Unit of Measure: Participants
Hemoglobin, low 0 1
Hemoglobin, high NA [1]  NA [1] 
Hematocrit, low 0 0
Hematocrit, high NA [1]  NA [1] 
Erythrocytes, low 0 2
Erythrocytes, high NA [1]  NA [1] 
Platelet count, low 0 0
Platelet count, high 0 0
Leukocytes, low 0 2
Leukocytes, high 0 1
Neutrophils + bands (absolute), low 0 0
Neutrophils + bands (absolute), high NA [1]  NA [1] 
Eosinophils (absolute), low NA [1]  NA [1] 
Eosinophils (absolute), high 1 2
Basophils (absolute), low NA [1]  NA [1] 
Basophils (absolute), high 0 0
Monocytes (absolute), low NA [1]  NA [1] 
Monocytes (absolute), high 0 0
Lymphocytes (absolute), low 11 8
Lymphocytes (absolute), high 0 0
[1]
Not evaluated.
16.Secondary Outcome
Title Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description 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.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: Participants
Alkaline phosphatase (ALP), low NA [1]  NA [1] 
ALP, high 0 0
Aspartate aminotransferase (AST), low NA [1]  NA [1] 
AST, high 0 1
Alanine aminotransferase (ALT), low NA [1]  NA [1] 
ALT, high 0 0
G-glutamyl transferase (GGT), low NA [1]  NA [1] 
GGT, high 1 0
Bilirubin, total, low NA [1]  NA [1] 
Bilirubin, total, high 0 0
Blood urea nitrogen, low NA [1]  NA [1] 
Blood urea nitrogen, high 0 0
Creatinine, low NA [1]  NA [1] 
Creatinine, high 0 3
[1]
Not evaluated
17.Secondary Outcome
Title Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description 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.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: Participants
Sodium, serum, low 0 0
Sodium, serum, high 0 0
Potassium, serum, low 0 0
Potassium, serum, high 0 0
Chloride, serum, low 0 0
Chloride, serum, high 0 0
Calcium, total, low 0 0
Calcium, total, high 0 0
Phosphorus, inorganic, low 0 0
Phosphorus, inorganic, high 0 0
18.Secondary Outcome
Title Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description 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.
Time Frame Baseline to Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 56 56
Measure Type: Number
Unit of Measure: Participants
Alkaline phosphatase (ALP), low NA [1]  NA [1] 
ALP, high 0 0
Aspartate aminotransferase (AST), low NA [1]  NA [1] 
AST, high 0 2
Alanine aminotransferase (ALT), low NA [1]  NA [1] 
ALT, high 0 1
G-glutamyl transferase (GGT), low NA [1]  NA [1] 
GGT, high 1 2
Bilirubin, total, low NA [1]  NA [1] 
Bilirubin, total, high 0 0
Blood urea nitrogen, low NA [1]  NA [1] 
Blood urea nitrogen, high 1 1
Creatinine, low NA [1]  NA [1] 
Creatinine, high 0 4
[1]
Not evaluated.
19.Secondary Outcome
Title Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description 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.
Time Frame Baseline to Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept, 125 mg Intravenous (IV) Abatacept, 125 mg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 56 56
Measure Type: Number
Unit of Measure: Participants
Sodium, serum, low 1 0
Sodium, serum, high 0 0
Potassium, serum, low 0 2
Potassium, serum, high 0 0
Chloride, serum, low 0 0
Chloride, serum, high 0 0
Calcium, total, low 0 0
Calcium, total, high 0 0
Phosphorus, inorganic, low 0 0
Phosphorus, inorganic, high 0 1
Time Frame Day 1 to 6 months post last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept Long-term (LT) SC 125 mg Short Term Intravenous (IV) Abatacept, 125 mg Short Term Subcutaneous (SC) Abatacept, 125 mg
Hide Arm/Group Description 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 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 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.
All-Cause Mortality
Abatacept Long-term (LT) SC 125 mg Short Term Intravenous (IV) Abatacept, 125 mg Short Term Subcutaneous (SC) Abatacept, 125 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept Long-term (LT) SC 125 mg Short Term Intravenous (IV) Abatacept, 125 mg Short Term Subcutaneous (SC) Abatacept, 125 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/112 (8.93%)   3/59 (5.08%)   4/59 (6.78%) 
Eye disorders       
Cataract  1  2/112 (1.79%)  0/59 (0.00%)  0/59 (0.00%) 
Gastrointestinal disorders       
Abdominal pain lower  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Haemorrhoids  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Colonic polyp  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
General disorders       
Medical device complication  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Pyrexia  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Hepatobiliary disorders       
Cholangitis acute  1  0/112 (0.00%)  0/59 (0.00%)  1/59 (1.69%) 
Infections and infestations       
Pneumonia bacterial  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Dacryocystitis  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Pneumonia  1  0/112 (0.00%)  1/59 (1.69%)  0/59 (0.00%) 
Pneumonia cryptococcal  1  0/112 (0.00%)  0/59 (0.00%)  1/59 (1.69%) 
Injury, poisoning and procedural complications       
Femur fracture  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Extranodal marginal zone B-cell lymphoma (MALT type)  1  0/112 (0.00%)  1/59 (1.69%)  0/59 (0.00%) 
Breast cancer  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Gastric cancer  1  0/112 (0.00%)  0/59 (0.00%)  1/59 (1.69%) 
Colon cancer  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease  1  1/112 (0.89%)  0/59 (0.00%)  1/59 (1.69%) 
Organising pneumonia  1  0/112 (0.00%)  1/59 (1.69%)  0/59 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermal cyst  1  1/112 (0.89%)  0/59 (0.00%)  0/59 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept Long-term (LT) SC 125 mg Short Term Intravenous (IV) Abatacept, 125 mg Short Term Subcutaneous (SC) Abatacept, 125 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   68/112 (60.71%)   35/59 (59.32%)   25/59 (42.37%) 
Gastrointestinal disorders       
Constipation  1  2/112 (1.79%)  0/59 (0.00%)  4/59 (6.78%) 
Periodontitis  1  4/112 (3.57%)  4/59 (6.78%)  0/59 (0.00%) 
Diarrhoea  1  2/112 (1.79%)  4/59 (6.78%)  0/59 (0.00%) 
Gastritis  1  3/112 (2.68%)  1/59 (1.69%)  3/59 (5.08%) 
Nausea  1  6/112 (5.36%)  2/59 (3.39%)  1/59 (1.69%) 
Stomatitis  1  18/112 (16.07%)  8/59 (13.56%)  7/59 (11.86%) 
Infections and infestations       
Nasopharyngitis  1  32/112 (28.57%)  16/59 (27.12%)  9/59 (15.25%) 
Gastroenteritis  1  7/112 (6.25%)  0/59 (0.00%)  1/59 (1.69%) 
Pharyngitis  1  6/112 (5.36%)  6/59 (10.17%)  1/59 (1.69%) 
Investigations       
Alanine aminotransferase increased  1  9/112 (8.04%)  4/59 (6.78%)  0/59 (0.00%) 
Aspartate aminotransferase increased  1  8/112 (7.14%)  1/59 (1.69%)  0/59 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Upper respiratory tract inflammation  1  3/112 (2.68%)  3/59 (5.08%)  1/59 (1.69%) 
Oropharyngeal pain  1  2/112 (1.79%)  1/59 (1.69%)  5/59 (8.47%) 
Skin and subcutaneous tissue disorders       
Rash  1  1/112 (0.89%)  3/59 (5.08%)  2/59 (3.39%) 
Vascular disorders       
Hypertension  1  6/112 (5.36%)  4/59 (6.78%)  1/59 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01001832     History of Changes
Other Study ID Numbers: IM101-250
First Submitted: October 26, 2009
First Posted: October 27, 2009
Results First Submitted: October 22, 2012
Results First Posted: February 7, 2013
Last Update Posted: February 6, 2014