Trial Outcomes & Findings for Phase IIIB Subcutaneous Missed Dose Study (NCT NCT00533897)
NCT ID: NCT00533897
Last Updated: 2015-04-23
Results Overview
Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
270 participants
Primary outcome timeframe
Day 169
Results posted on
2015-04-23
Participant Flow
Participants with Rheumatoid Arthritis (American College of Rheumatology Class I, II or III) were enrolled. Study initiated November 2007. Short Term (ST) results and some long term extension (LTE) results up to a database lock in 2010 were released earlier. Study concluded February 2014. Final LTE results are now included.
270 participants enrolled; 167 were treated in the Short Term (ST) study. 103 were not treated (10 withdrew consent, 2 lost to follow-up, 91 no longer met study criteria). ST study included 3 Periods: Lead-In (LI), Doubleblind Withdrawal (DBW), and Reintroduction (RI).150 participants entered the LTE study.
Participant milestones
| Measure |
Abatacept (ABA) [Lead-In (LI)]
On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (\<60 kg=500 mg, 60-100 kg=750 mg, \>100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
|
Abatacept (ABA) Double-blind Withdrawal (DBW)
After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
|
Placebo (PLA) Double Blind Withdrawal (DBW)
After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
|
ABA With IV PLA Loading Dose in Re-introduction (RI) Period
After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
|
PLA Switched to ABA With ABA IV Loading Dose in RI Period
After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (\<60 kg=500 mg, 60-100 kg=750 mg, \>100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
|
PLA Switched to ABA With PLA IV Loading Dose in RI Period
After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
|
Long Term Extension Abatacept for LI Period Non-responders
Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
|
Long Term Extension (LTE) Abatacept for Short Term Completers
Participant's who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
|
|---|---|---|---|---|---|---|---|---|
|
Lead-in (LI) Period 1
STARTED
|
167
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in (LI) Period 1
COMPLETED
|
157
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in (LI) Period 1
NOT COMPLETED
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Withdrawal (DBW) Period 2
STARTED
|
0
|
40
|
80
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Withdrawal (DBW) Period 2
COMPLETED
|
0
|
39
|
77
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Withdrawal (DBW) Period 2
NOT COMPLETED
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Re-introduction (RI) Period 3
STARTED
|
0
|
0
|
0
|
40
|
35
|
44
|
0
|
0
|
|
Re-introduction (RI) Period 3
COMPLETED
|
0
|
0
|
0
|
40
|
35
|
42
|
0
|
0
|
|
Re-introduction (RI) Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Long Term Extension (LTE)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
37
|
113
|
|
Long Term Extension (LTE)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
24
|
88
|
|
Long Term Extension (LTE)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
25
|
Reasons for withdrawal
| Measure |
Abatacept (ABA) [Lead-In (LI)]
On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (\<60 kg=500 mg, 60-100 kg=750 mg, \>100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
|
Abatacept (ABA) Double-blind Withdrawal (DBW)
After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
|
Placebo (PLA) Double Blind Withdrawal (DBW)
After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
|
ABA With IV PLA Loading Dose in Re-introduction (RI) Period
After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
|
PLA Switched to ABA With ABA IV Loading Dose in RI Period
After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (\<60 kg=500 mg, 60-100 kg=750 mg, \>100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
|
PLA Switched to ABA With PLA IV Loading Dose in RI Period
After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
|
Long Term Extension Abatacept for LI Period Non-responders
Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
|
Long Term Extension (LTE) Abatacept for Short Term Completers
Participant's who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
|
|---|---|---|---|---|---|---|---|---|
|
Lead-in (LI) Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in (LI) Period 1
Participant Withdrew Consent
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in (LI) Period 1
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in (LI) Period 1
Administrative Reason By Sponsor
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in (LI) Period 1
Lack of Efficacy
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in (LI) Period 1
Missed 2 Consecutive Doses of Study Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Withdrawal (DBW) Period 2
Lack of Efficacy
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Withdrawal (DBW) Period 2
Poor/Non-Compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Re-introduction (RI) Period 3
Participant Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Re-introduction (RI) Period 3
No Longer Meets Study Criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Long Term Extension (LTE)
Participant Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
5
|
|
Long Term Extension (LTE)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Long Term Extension (LTE)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
3
|
|
Long Term Extension (LTE)
Poor/Non-compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Long Term Extension (LTE)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
5
|
|
Long Term Extension (LTE)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Long Term Extension (LTE)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Long Term Extension (LTE)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
Baseline Characteristics
Phase IIIB Subcutaneous Missed Dose Study
Baseline characteristics by cohort
| Measure |
Period 1 Non-Responders
n=37 Participants
Participants received abatacept (ABA) intravenous (IV) loading dose and subcutaneous (SC) injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 non-responders skipped Periods 2 and 3 and entered the long term extension (LTE).
|
Abatacept Received in Period 2
n=40 Participants
Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to ABA (Day 85-169).
|
Placebo Received in Period 2
n=80 Participants
Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to Placebo (Day 85-169).
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 169Population: Participants treated in the DBW Period with at least 1 immunogenicity result (ELISA) during DBW Period. N=Number of Participants Analyzed, n=number of participants with data for that time point
Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169
Anti-abatacept (n=37, n=71)
|
0 percentage of participants
|
1.4 percentage of participants
|
—
|
|
Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169
Anti-CTLA4-T (n=38, n=73)
|
0 percentage of participants
|
8.2 percentage of participants
|
—
|
|
Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169
Total (n=38, n=73)
|
0 percentage of participants
|
9.6 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 253 (short term)Population: Participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point.
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=79 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups
Anti-abatacept (n=38, n=73)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups
Anti-CTLA4-T (n=38, n=73)
|
2.6 percentage of participants
|
2.7 percentage of participants
|
—
|
|
Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups
Total (n=38, n=73)
|
2.6 percentage of participants
|
2.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 253 (short term)Population: Participants treated with Placebo in DBW period who were treated in RI period and had at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=44 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group
Anti-abatacept (n=32, n=41)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group
Anti-CTLA4-T (n=32, n=41)
|
0 percentage of participants
|
4.9 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group
Total (n=32, n=41)
|
0 percentage of participants
|
4.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drugPopulation: All participants treated in LI Period who had at least 1 immunogenicity result (ELISA) during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall on TRT visits: anti-ABA (n=162)
|
1.2 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall on TRT visits: anti-CTLA4 (n=165)
|
0 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall on TRT visits: Total (n=165)
|
1.2 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall post visits: anti-ABA (n=3)
|
0 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall post visits: anti-CTLA4 (n=3)
|
0 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall post visits: Total (n=3)
|
0 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall anti-ABA (n=162)
|
1.2 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall anti-CTLA4 (n=165)
|
0 percentage of participants
|
—
|
—
|
|
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall Total (n=165)
|
1.2 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drugPopulation: All participants treated in Period 1 (Lead-in Period). N=Number of Participants Analyzed, n=number of participants with data for that time point
ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall onTRT visits CTLA4 and Possibly Ig, n=165
|
1.2 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall onTRT visits Ig and/or JNC region, n=165
|
0 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall onTRT visits Total, n=165
|
1.2 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall post visits CTLA4 and possibly Ig, n=3
|
0 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall post visits Ig and/or JNC region, n=3
|
0 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall post visits: Total, n=3
|
0 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall CTLA4 and possibly Ig, n=165
|
1.2 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall Ig and/or JNC region, n=165
|
0 percentage of participants
|
—
|
—
|
|
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
Overall Total (n=165)
|
1.2 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI PeriodPopulation: All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point.
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Samples were obtained during treatment (TRT) visits.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall on TRT visits: anti-ABA, n=39,78
|
0 percentage of participants
|
1.3 percentage of participants
|
—
|
|
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall on TRT visits anti-CTLA4, n=40,80
|
0 percentage of participants
|
7.5 percentage of participants
|
—
|
|
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Overall on TRT visits: Total, n=40,80
|
0 percentage of participants
|
8.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 22 after last dose of drug to Day 85 after last dose of drugPopulation: These data were not summarized since there were no participants at any post visits.
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI PeriodPopulation: All participants treated in DBW period with at least 1 immunogenicity result (ECL) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point
ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time
Overall onTRT visits CTLA4 and Possibly Ig,n=40,80
|
0 percentage of participants
|
6.3 percentage of participants
|
—
|
|
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time
Overall onTRT visits Ig and/or JNC region, n=40,80
|
0 percentage of participants
|
3.8 percentage of participants
|
—
|
|
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time
Overall on TRT visits: Total Abs, n=40,80
|
0 percentage of participants
|
10.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 22 after last dose of drug to Day 85 after last dose of drugPopulation: These data were not summarized since there were no participants at any post visits
ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drugPopulation: All participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point.
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=79 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group
Overall onTRT visits: anti-ABA, n=39,77
|
2.6 percentage of participants
|
1.3 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group
Overall onTRT visits anti-CTLA4, n=40,78
|
5.0 percentage of participants
|
3.8 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group
Overall onTRT visits: Total, n=40,78
|
7.5 percentage of participants
|
5.1 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group
Overall post visits: anti-ABA, n=1,4
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group
Overall post visits: anti-CTLA4, n=1,4
|
0 percentage of participants
|
25.0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group
Overall post visits: Total, n=1,4
|
0 percentage of participants
|
25.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drugPopulation: All participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point
ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=79 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group
Overall onTRT visits CTLA4 and Possibly Ig,n=40,78
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group
Overall onTRT visits Ig and/or JNC region, n=40,78
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group
Overall onTRT visits: Total, n=40,78
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group
Overall post visits: CTLA4 and possibly Ig, n=1,4
|
100.0 percentage of participants
|
25.0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group
Overall post visits: Ig and/or JNC region, n=1,4
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group
Overall post visits: Total, n=1,4
|
100.0 percentage of participants
|
25.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drugPopulation: All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.
Serum samples from Abatacept-treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. ST was defined as the LI Period, the DBW Period, and the RI Period (Days 1-253).
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study anti-CTLA4, n=40, 80
|
5.0 percentage of participants
|
8.8 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study onTRT visits: anti-ABA, n=39,78
|
7.7 percentage of participants
|
1.3 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study onTRT visits anti-CTLA4, n=40,80
|
5.0 percentage of participants
|
8.8 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study onTRT visits: Total, n=40,80
|
12.5 percentage of participants
|
10.0 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study post visits: anti-ABA, n=1, 4
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study post visits: anti-CTLA4, n=1, 4
|
0 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study post visits: Total, n=1, 4
|
0 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study anti-ABA, n=39, 78
|
7.7 percentage of participants
|
1.3 percentage of participants
|
—
|
|
Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups
Overall study Total, n=40,80
|
12.5 percentage of participants
|
10.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drugPopulation: All participants treated in DBW period with at least 1 immunogenicity result (ECL) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.
ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall onTRT visits CTLA and possibly Ig,n=40,80
|
0 percentage of Participants
|
7.5 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall onTRT visits Ig and/or JNC region,n=40,80
|
0 percentage of Participants
|
3.8 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall study onTRT visits: Total, n=40,80
|
0 percentage of Participants
|
10.0 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall post visits CTLA4 and possibly Ig,n=1,4
|
100.0 percentage of Participants
|
25.0 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall post visits: Ig and/or JNC region, n=1,4
|
0 percentage of Participants
|
0 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall study post visits: Total, n=1, 4
|
100.0 percentage of Participants
|
25.0 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall study CTLA4 and possibly Ig,n=40,80
|
2.5 percentage of Participants
|
8.8 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall study Ig and/or JNC region, n=40, 80
|
0 percentage of Participants
|
3.8 percentage of Participants
|
—
|
|
Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups
Overall study Total, n=40,80
|
2.5 percentage of Participants
|
11.3 percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)Population: Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.
The DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 15, n=38, n=75
|
-0.64 units on a scale
Standard Error 0.10
|
-0.87 units on a scale
Standard Error 0.08
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 29, n=40, n=80
|
-1.07 units on a scale
Standard Error 0.14
|
-1.10 units on a scale
Standard Error 0.09
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 57, n=40. n=79
|
-1.39 units on a scale
Standard Error 0.14
|
-1.62 units on a scale
Standard Error 0.11
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 78, n=33, n=76
|
-1.76 units on a scale
Standard Error 0.12
|
-1.89 units on a scale
Standard Error 0.10
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 85, n=40, n=78
|
-1.97 units on a scale
Standard Error 0.11
|
-1.88 units on a scale
Standard Error 0.11
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 113, n=39, n=80
|
-1.78 units on a scale
Standard Error 0.18
|
-1.69 units on a scale
Standard Error 0.12
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 141, n=38, n=76
|
-1.81 units on a scale
Standard Error 0.17
|
-1.54 units on a scale
Standard Error 0.14
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 169, n=38, n=75
|
-2.03 units on a scale
Standard Error 0.18
|
-1.49 units on a scale
Standard Error 0.14
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 197, n=40, n=79
|
-2.14 units on a scale
Standard Error 0.16
|
-1.92 units on a scale
Standard Error 0.13
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 225, n=39, n=77
|
-2.20 units on a scale
Standard Error 0.17
|
-2.04 units on a scale
Standard Error 0.13
|
—
|
|
Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups
Day 253, n=39, n=74
|
-2.22 units on a scale
Standard Error 0.14
|
-2.32 units on a scale
Standard Error 0.12
|
—
|
SECONDARY outcome
Timeframe: Days 85, 169, and 253 (short term)Population: Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and, when relevant, at baseline.
DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 85 CMI , n=40, n=78
|
80 percentage of participants
|
76.9 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 85 LDAS, n=40, n=78
|
67.5 percentage of participants
|
62.8 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 85 Clinical Remission, n=40, n=78
|
35.0 percentage of participants
|
37.2 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 169 CMI , n=38, n=75
|
78.9 percentage of participants
|
57.3 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 169 LDAS, n=38, n=75
|
68.4 percentage of participants
|
54.7 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 169 Clinical Remission, n=38, n=75
|
47.4 percentage of participants
|
28.0 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 253 CMI , n=39, n=74
|
87.2 percentage of participants
|
89.2 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 253 LDAS, n=39, n=74
|
69.2 percentage of participants
|
79.7 percentage of participants
|
—
|
|
Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups
Day 253 Clinical Remission, n=39, n=74
|
51.3 percentage of participants
|
63.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)Population: Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.
The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 15, n=40, n=77
|
-0.31 units on a scale
Standard Error 0.06
|
-0.30 units on a scale
Standard Error 0.04
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 29, n=40, n=80
|
-0.46 units on a scale
Standard Error 0.05
|
-0.35 units on a scale
Standard Error 0.04
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 57, n=40, n=79
|
-0.58 units on a scale
Standard Error 0.09
|
-0.51 units on a scale
Standard Error 0.06
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 78, n=33, n=77
|
-0.68 units on a scale
Standard Error 0.10
|
-0.59 units on a scale
Standard Error 0.07
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 85, n=40, n=79
|
-0.74 units on a scale
Standard Error 0.09
|
-0.63 units on a scale
Standard Error 0.07
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 113, n=40, n=80
|
-0.69 units on a scale
Standard Error 0.08
|
-0.61 units on a scale
Standard Error 0.06
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 141, n=39, n=78
|
-0.68 units on a scale
Standard Error 0.10
|
-0.52 units on a scale
Standard Error 0.07
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 169, n=38, n=76
|
-0.72 units on a scale
Standard Error 0.11
|
-0.50 units on a scale
Standard Error 0.07
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 197, n=40, n=79
|
-0.76 units on a scale
Standard Error 0.09
|
-0.66 units on a scale
Standard Error 0.06
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 225, n=40, n=77
|
-0.82 units on a scale
Standard Error 0.10
|
-0.70 units on a scale
Standard Error 0.06
|
—
|
|
Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups
Day 253, n=39, n=74
|
-0.86 units on a scale
Standard Error 0.09
|
-0.72 units on a scale
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)Population: Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.
The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 15, n=40, n=77
|
47.5 percentage of Participants
|
42.9 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 29, n=40, n=80
|
62.5 percentage of Participants
|
52.5 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 57, n=40, n=79
|
67.5 percentage of Participants
|
62.0 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 78, n=33, n=77
|
66.7 percentage of Participants
|
67.5 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 85, n=40, n=79
|
80.0 percentage of Participants
|
69.6 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 113, n=40, n=80
|
75.0 percentage of Participants
|
67.5 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 141, n=39, n=78
|
69.2 percentage of Participants
|
62.8 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 169, n=38, n=76
|
71.1 percentage of Participants
|
56.6 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 197, n=40, n=79
|
75.0 percentage of Participants
|
74.7 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 225, n=40, n=77
|
80.0 percentage of Participants
|
76.6 percentage of Participants
|
—
|
|
Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups
Day 253, n=39, n=74
|
84.6 percentage of Participants
|
74.3 percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 15, 29, 57, 78, 85Population: Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.
DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI; Mean Change in DAS 28 (CRP) From Baseline Over Time
Day 15, n=150
|
-0.72 units on a scale
Standard Error 0.06
|
—
|
—
|
|
LI; Mean Change in DAS 28 (CRP) From Baseline Over Time
Day 29, n=165
|
-1.00 units on a scale
Standard Error 0.07
|
—
|
—
|
|
LI; Mean Change in DAS 28 (CRP) From Baseline Over Time
Day 57, n=164
|
-1.35 units on a scale
Standard Error 0.08
|
—
|
—
|
|
LI; Mean Change in DAS 28 (CRP) From Baseline Over Time
Day 78, n=143
|
-1.39 units on a scale
Standard Error 0.10
|
—
|
—
|
|
LI; Mean Change in DAS 28 (CRP) From Baseline Over Time
Day 85, n=161
|
-1.53 units on a scale
Standard Error 0.10
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 78, 85Population: Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.
DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time
Day 15, n=150
|
26.0 percentage of participants
|
—
|
—
|
|
LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time
Day 29, n=165
|
40.6 percentage of participants
|
—
|
—
|
|
LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time
Day 57, n=164
|
56.1 percentage of participants
|
—
|
—
|
|
LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time
Day 78, n=143
|
59.4 percentage of participants
|
—
|
—
|
|
LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time
Day 85, n=161
|
64.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 85 (Period 2 Baseline), 113, 141, and 169Population: Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at DBW period baseline.
DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time
Day 113, n=39, n=76
|
0.19 units on a scale
Standard Error 0.18
|
0.16 units on a scale
Standard Error 0.11
|
—
|
|
DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time
Day 141 , n=38, n=73
|
0.14 units on a scale
Standard Error 0.17
|
0.35 units on a scale
Standard Error 0.15
|
—
|
|
DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time
Day 169, n=38, n=72
|
-0.06 units on a scale
Standard Error 0.19
|
0.40 units on a scale
Standard Error 0.14
|
—
|
SECONDARY outcome
Timeframe: Days 85, 113, 141, and 169Population: Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point.
A participant had an RA flare if at least 2 of the following criteria were met: * Doubling of tender and swollen joint count from Day 78 * Increase in DAS28-CRP score ≥ 1.2 from Day 78 * Prematurely discontinued from Double-blind Withdrawal Period (Period 2) and continued to Re-introduction Period (Period 3)
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time
Day 85, n=31, n=66
|
0 percentage of participants
|
1.5 percentage of participants
|
—
|
|
DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time
Day 113, n=33, n=77
|
9.1 percentage of participants
|
2.6 percentage of participants
|
—
|
|
DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time
Day 141, n=32, n=73
|
6.3 percentage of participants
|
6.8 percentage of participants
|
—
|
|
DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time
Day 169, n=33, n=74
|
6.1 percentage of participants
|
9.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 169 (Period III Baseline), 197, 225, and 253Population: Participants who received at least 1 dose of study medication during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at RI period baseline.
DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time
Day 197, n=39, n=33, n=44
|
-0.26 units on a scale
Standard Error 0.17
|
-0.56 units on a scale
Standard Error 0.17
|
-0.50 units on a scale
Standard Error 0.16
|
|
RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time
Day 225, n=38, n=33, n=42
|
-0.31 units on a scale
Standard Error 0.20
|
-0.59 units on a scale
Standard Error 0.18
|
-0.66 units on a scale
Standard Error 0.17
|
|
RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time
Day 253, n=38, n=30, n=42
|
-0.23 units on a scale
Standard Error 0.16
|
-0.93 units on a scale
Standard Error 0.20
|
-0.89 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication during LI period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
Deaths
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
SAEs
|
3 participants
|
—
|
—
|
|
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
Related SAEs
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
SAEs Leading to Discontinuation
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
AEs
|
82 participants
|
—
|
—
|
|
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
Related AEs
|
29 participants
|
—
|
—
|
|
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication during LI period
AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI Period; Number of Participants With AEs of Special Interest
Infections and infestations
|
42 participants
|
—
|
—
|
|
LI Period; Number of Participants With AEs of Special Interest
Malignancies
|
0 participants
|
—
|
—
|
|
LI Period; Number of Participants With AEs of Special Interest
Autoimmune events (prespecified)
|
0 participants
|
—
|
—
|
|
LI Period; Number of Participants With AEs of Special Interest
Acute infusional events (prespecified)
|
1 participants
|
—
|
—
|
|
LI Period; Number of Participants With AEs of Special Interest
Peri-infusional events (prespecified)
|
2 participants
|
—
|
—
|
|
LI Period; Number of Participants With AEs of Special Interest
Local injection site reactions (prespecified)
|
2 participants
|
—
|
—
|
|
LI Period; Number of Participants With AEs of Special Interest
Systemic injection reactions (prespecified)
|
9 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication during LI period.
Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 cells/ microliter (uL); eosinophils: \>0.750 \* 10\^3 cells/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 cells/uL/ \>7.50 \* 10\^3 cells/uL.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
Low HGB
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
Low hematocrit
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
Low erythrocytes
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
Low PLT
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
High PLT
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
Low leukocytes
|
3 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
High leukocytes
|
4 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
Low neutrophils+bands
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
High eosinophils
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
High basophils
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
High monocytes
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
Low lymphocytes
|
7 participants
|
—
|
—
|
|
LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria
High lymphocytes
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication during LI period.
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High ALP
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High AST
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High ALT
|
2 participants
|
—
|
—
|
|
LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High GGT
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High bilirubin
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High BUN
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High creatinine
|
3 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication during LI period.
Marked abnormality criteria: Sodium (Na): \<0.95\*LLN/ \>1.05\*ULN, or if BL\<LLN then use \<0.95\* BL or \>ULN, or if BL\>ULN then use\>1.05\* BL or \<LLN; potassium (K): \<0.9\* LLN/\>1.1\*ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; (Cl): \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; calcium (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use \<0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
Low Na
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
High Na
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
Low K
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
High K
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
Low Cl
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
High Cl
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
Low Ca
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
High Ca
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
Low P
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria
High P
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during LI period.
MA criteria: serum glucose (Glu): \<65 mg/dL/\>220 mg/dL;fasting serum Glu: \<0.8\* LLN/\>1.5\*upper limits of normal (ULN),or if BL\< lower limits of normal (LLN) then use 0.8\*BL or \> upper limits of normal (ULN),or if BL\>ULN then use \>2.0\*BL or \<LLN;total protein: \<0.9\*LLN/\>1.1\*ULN,or if BL\<LLN then use \<0.9\*BL or \>ULN,or if BL\>UNL then use \>1.1\*BL or \<LLN; albumin: \<0.9\*LLN,or if BL\<LLN then use \<0.75 BL;uric acid: \>1.5\*ULN,or if BL\>ULN then use \>2\*BL. Urinalysis: Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells (RBCs), White Blood Cells (WBCs):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low Glu (n=167)
|
9 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High Glu (n=167)
|
4 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low fasting Glu (n=92)
|
3 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High fasting glucose (n=92)
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low protein (n=167)
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High protein (n=167)
|
1 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low Albumin (n=167)
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High uric acid (n=167)
|
0 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine protein (n=167)
|
3 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine Glu (n=167)
|
3 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine blood (n=167)
|
17 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High leukocyte esterase (n=46)
|
9 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine RBC (n=44)
|
7 participants
|
—
|
—
|
|
LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine WBC (n=63)
|
26 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57, 78, and 85Population: Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.
Blood pressure was taken in participants while seated and measured in millimeters of mercury (mmHg). Pressures were assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1 SBP before infusion (n=160)
|
125.0 mmHg
Standard Deviation 18.42
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 15 SBP before injection (n=156)
|
122.3 mmHg
Standard Deviation 14.55
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 29 SBP before injection (n=161)
|
122.0 mmHg
Standard Deviation 14.02
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 57 SBP before injection (n=157)
|
121.4 mmHg
Standard Deviation 14.87
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 78 SBP before injection (n=157)
|
120.3 mmHg
Standard Deviation 14.38
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 85 SBP before injection (n=159)
|
122.0 mmHg
Standard Deviation 15.19
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1 DBP before infusion (n=160)
|
76.0 mmHg
Standard Deviation 10.88
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 15 DBP before injection (n=156)
|
75.8 mmHg
Standard Deviation 9.63
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 29 DBP before injection (n=161)
|
76.1 mmHg
Standard Deviation 9.43
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 57 DBP before injection (n=157)
|
75.7 mmHg
Standard Deviation 9.82
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 78 DBP before injection (n=157)
|
75.4 mmHg
Standard Deviation 10.29
|
—
|
—
|
|
LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 85 DBP before injection (n=159)
|
75.2 mmHg
Standard Deviation 9.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57, 78, and 85Population: Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.
Heart rate was taken in participants while seated and measured in beats per minute (bpm). Heart rate was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI Period; Mean Heart Rate (HR)
Day 1 HR before infusion (n=167)
|
73.9 bpm
Standard Deviation 9.78
|
—
|
—
|
|
LI Period; Mean Heart Rate (HR)
Day 15 HR before injection (n=160)
|
76.0 bpm
Standard Deviation 7.91
|
—
|
—
|
|
LI Period; Mean Heart Rate (HR)
Day 29 HR before injection (n=166)
|
75.5 bpm
Standard Deviation 9.03
|
—
|
—
|
|
LI Period; Mean Heart Rate (HR)
Day 57 HR before injection (n=164)
|
75.5 bpm
Standard Deviation 8.95
|
—
|
—
|
|
LI Period; Mean Heart Rate (HR)
Day 78 HR before injection (n=158)
|
75.1 bpm
Standard Deviation 7.78
|
—
|
—
|
|
LI Period; Mean Heart Rate (HR)
Day 85 HR before injection (n=160)
|
74.7 bpm
Standard Deviation 8.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57, 78, and 85Population: Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.
Temperature was taken in participants while seated and measured in degrees celsius. Temperature was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.
Outcome measures
| Measure |
Abatacept in DBW Period
n=167 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LI Period; Mean Temperature (T)
Day 1 T before infusion (n=167)
|
36.39 degrees Celsius
Standard Deviation 0.387
|
—
|
—
|
|
LI Period; Mean Temperature (T)
Day 15 T before injection (n=160)
|
36.34 degrees Celsius
Standard Deviation 0.351
|
—
|
—
|
|
LI Period; Mean Temperature (T)
Day 29 T before injection (n=166)
|
36.39 degrees Celsius
Standard Deviation 0.371
|
—
|
—
|
|
LI Period; Mean Temperature (T)
Day 57 T before injection (n=164)
|
36.38 degrees Celsius
Standard Deviation 0.329
|
—
|
—
|
|
LI Period; Mean Temperature (T)
Day 78 T before injection (n=158)
|
36.33 degrees Celsius
Standard Deviation 0.333
|
—
|
—
|
|
LI Period; Mean Temperature (T)
Day 85 T before injection (n=160)
|
36.35 degrees Celsius
Standard Deviation 0.368
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication in DBW period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Deaths
|
0 participants
|
2 participants
|
—
|
|
DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
SAEs
|
0 participants
|
2 participants
|
—
|
|
DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Related SAEs
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
AEs
|
13 participants
|
29 participants
|
—
|
|
DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Related AEs
|
2 participants
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication in DBW period
AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW; Number of Participants With AEs of Special Interest
Infections and infestations
|
5 participants
|
7 participants
|
—
|
|
DBW; Number of Participants With AEs of Special Interest
Malignancies
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With AEs of Special Interest
Autoimmune disorders (prespecified)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With AEs of Special Interest
Acute infusional events (prespecified)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With AEs of Special Interest
Peri-infusional events (prespecified)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With AEs of Special Interest
Local injection site reactions (prespecified)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With AEs of Special Interest
Systemic injection reactions (prespecified)
|
1 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.
Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 cells/uL; eosinophils: \>0.750 \* 10\^3 cells/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 cells/uL/ \>7.50 \* 10\^3 cells/uL.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low HGB (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low hematocrit (n=39, n=79)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low erythrocytes (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low PLT (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High PLT (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low leukocytes (n=40, n=80)
|
0 participants
|
1 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High leukocytes (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low neutrophils+bands (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High eosinophils (n=40, n=80)
|
0 participants
|
2 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High basophils (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High monocytes (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low lymphocytes (n=40, n=80)
|
2 participants
|
4 participants
|
—
|
|
DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High lymphocytes (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High ALP
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High AST
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High ALT
|
1 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High GGT
|
2 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High bilirubin
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High BUN
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High creatinine
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.
Marked abnormality criteria: Sodium (Na): \<0.95\*LLN/ \>1.05\*ULN, or if BL\<LLN then use \<0.95\* BL or \>ULN, or if BL\>ULN then use\>1.05\* BL or \<LLN; potassium (K): \<0.9\* LLN/\>1.1\*ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; (Cl): \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; calcium (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use \<0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low Na
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High Na
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low K
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High K
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low Cl
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High Cl
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low Ca
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High Ca
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low P
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High P
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlierPopulation: Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.
MA criteria: serum glucose (Glu): \<65 mg/dL/\>220 mg/dL;fasting serum Glu: \<0.8\* LLN/\>1.5\*ULN,or if BL\<LLN then use 0.8\*BL or \>ULN,or if BL\>ULN then use \>2.0\*BL or \<LLN;total protein: \<0.9\*LLN/\>1.1\*ULN,or if BL\<LLN then use \<0.9\*BL or \>UNL,or if BL\>UNL then use \>1.1\*BL or \<LLN; albumin: \<0.9\*LLN,or if BL\<LLN then use \<0.75 BL;uric acid: \>1.5\*ULN,or if BL\>ULN then use \>2\*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low Glu (n=40, n=80)
|
2 participants
|
5 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High Glu (n=40, n=80)
|
1 participants
|
3 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low fasting Glu (n=27, n=51)
|
0 participants
|
1 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High fasting Glu (n=27, n=51)
|
0 participants
|
1 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low total protein (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High total protein (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low albumin (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High uric acid (n=40, n=80)
|
0 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine protein (n=40, n=80)
|
1 participants
|
0 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine Glu (n=40, n=80)
|
0 participants
|
1 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine blood (n=40, n=80)
|
3 participants
|
10 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High leukocyte esterase (n=10, n=21)
|
1 participants
|
4 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine RBC (n=13, n=23)
|
1 participants
|
5 participants
|
—
|
|
DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine WBC (n=15, n=28)
|
6 participants
|
12 participants
|
—
|
SECONDARY outcome
Timeframe: Days 113, 141, and 169Population: Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
Blood pressures were taken in participants while seated, just prior to study drug injection, and measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period
Day 141 DBP before injection (n=39, n=76)
|
76.3 mm mercury (Hg)
Standard Deviation 10.46
|
76.0 mm mercury (Hg)
Standard Deviation 10.60
|
—
|
|
DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period
Day 113 SBP before injection (n=39, n=78)
|
119.4 mm mercury (Hg)
Standard Deviation 13.29
|
120.4 mm mercury (Hg)
Standard Deviation 15.60
|
—
|
|
DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period
Day 141 SBP before injection (n=39, n=76)
|
120.3 mm mercury (Hg)
Standard Deviation 12.73
|
121.2 mm mercury (Hg)
Standard Deviation 14.98
|
—
|
|
DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period
Day 169 SBP before injection (n=40, n=80)
|
119.6 mm mercury (Hg)
Standard Deviation 13.87
|
119.4 mm mercury (Hg)
Standard Deviation 14.11
|
—
|
|
DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period
Day 113 DBP before injection (n=39, 78)
|
74.2 mm mercury (Hg)
Standard Deviation 10.44
|
74.4 mm mercury (Hg)
Standard Deviation 9.34
|
—
|
|
DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period
Day 169 DBP before injection (n=40, n=80)
|
74.0 mm mercury (Hg)
Standard Deviation 9.51
|
74.7 mm mercury (Hg)
Standard Deviation 8.94
|
—
|
SECONDARY outcome
Timeframe: Days 113, 141, and 169Population: Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
Heart Rate was taken in participants while seated, just prior to study drug injection, and measured in beats per minute (bpm)
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW Period; Mean Heart Rate (HR) During Period 2
Day 113 HR before injection (n=40, n=78)
|
75.8 beats per minute (bpm)
Standard Deviation 8.07
|
73.9 beats per minute (bpm)
Standard Deviation 8.39
|
—
|
|
DBW Period; Mean Heart Rate (HR) During Period 2
Day 141 HR before injection (n=39, n=76)
|
75.9 beats per minute (bpm)
Standard Deviation 9.35
|
74.5 beats per minute (bpm)
Standard Deviation 8.45
|
—
|
|
DBW Period; Mean Heart Rate (HR) During Period 2
Day 169 HR before injection (n=40, n=80)
|
73.8 beats per minute (bpm)
Standard Deviation 8.19
|
74.2 beats per minute (bpm)
Standard Deviation 8.50
|
—
|
SECONDARY outcome
Timeframe: Days 113, 141, and 169Population: Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
Participants were seated and temperature taken just prior to study drug injection.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=80 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
DBW Period; Mean Temperature (T) During Period II
Day 113 T before infusion (n=40, n=78)
|
36.34 degrees Celsius
Standard Deviation 0.488
|
36.44 degrees Celsius
Standard Deviation 0.370
|
—
|
|
DBW Period; Mean Temperature (T) During Period II
Day 141 T before injection (n=39, n=76)
|
36.31 degrees Celsius
Standard Deviation 0.355
|
36.36 degrees Celsius
Standard Deviation 0.347
|
—
|
|
DBW Period; Mean Temperature (T) During Period II
Day 169 T before injection (n=40, n=80)
|
36.38 degrees Celsius
Standard Deviation 0.364
|
36.32 degrees Celsius
Standard Deviation 0.373
|
—
|
SECONDARY outcome
Timeframe: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.Population: Participants who received at least 1 dose of study medication in RI period.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
SAEs
|
0 participants
|
0 participants
|
1 participants
|
|
RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Related SAEs
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
SAEs Leading to Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
AEs
|
15 participants
|
17 participants
|
16 participants
|
|
RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Related AEs
|
1 participants
|
4 participants
|
4 participants
|
|
RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.Population: Participants who received at least 1 dose of study medication in RI period.
AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI; Number of Participants With AEs of Special Interest
Infections and infestations
|
7 participants
|
8 participants
|
7 participants
|
|
RI; Number of Participants With AEs of Special Interest
Malignancies
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With AEs of Special Interest
Autoimmune disorders (prespecified)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With AEs of Special Interest
Acute infusional events (prespecified)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With AEs of Special Interest
Peri-infusional events (prespecified)
|
0 participants
|
0 participants
|
1 participants
|
|
RI; Number of Participants With AEs of Special Interest
Local injection site reactions (prespecified)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With AEs of Special Interest
Systemic injection reactions (prespecified)
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.Population: Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.
Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 cells/uL; eosinophils: \>0.750 \* 10\^3 cells/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 cells/uL/ \>7.50 \* 10\^3 cells/uL.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low hematocrit
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low erythrocytes
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low PLT
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low HGB
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High PLT
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low leukocytes
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High leukocytes
|
0 participants
|
1 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low neutrophils+bands
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High eosinophils
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High basophils
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High monocytes
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
Low lymphocytes
|
2 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria
High lymphocytes
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.Population: Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High ALP
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High AST
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High ALT
|
2 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High GGT
|
1 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High bilirubin
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High BUN
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria
High creatinine
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.Population: Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.
Marked abnormality criteria: Sodium (Na): \<0.95\*LLN/ \>1.05\*ULN, or if BL\<LLN then use \<0.95\* BL or \>ULN, or if BL\>ULN then use\>1.05\* BL or \<LLN; potassium (K): \<0.9\* LLN/\>1.1\*ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; (Cl): \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; calcium (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use \<0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low Na
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High Na
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low K
|
0 participants
|
0 participants
|
1 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High K
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low Cl
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High Cl
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low Ca
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High Ca
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
Low P
|
0 participants
|
1 participants
|
0 participants
|
|
RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria
High P
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.Population: Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.
MA criteria: serum glucose (Glu): \<65 mg/dL/\>220 mg/dL;fasting serum Glu: \<0.8\* LLN/\>1.5\*ULN,or if BL\<LLN then use 0.8\*BL or \>ULN,or if BL\>ULN then use \>2.0\*BL or \<LLN;total protein: \<0.9\*LLN/\>1.1\*ULN,or if BL\<LLN then use \<0.9\*BL or \>UNL,or if BL\>UNL then use \>1.1\*BL or \<LLN; albumin: \<0.9\*LLN,or if BL\<LLN then use \<0.75 BL;uric acid: \>1.5\*ULN,or if BL\>ULN then use \>2\*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low Glu (n=40, n=35, n=44)
|
1 participants
|
1 participants
|
1 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High Glu (n=40, n=35, n=44)
|
0 participants
|
1 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low fasting Glu (n=27, n=20, n=28)
|
1 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High fasting glucose (n=27, n=20, n=28)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low total protein (n=40, n=35, n=44)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High total protein (n=40, n=35, n=44)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
Low albumin (n=40, n=35, n=44)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High uric acid (n=40, n=35, n=44)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine protein (n=40, n=35, n=44)
|
0 participants
|
0 participants
|
1 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine glucose (n=40, n=34, n=44)
|
0 participants
|
0 participants
|
0 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine blood (n=40, n=35, n=44)
|
6 participants
|
4 participants
|
7 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High leukocyte esterase (n=14, n=8, n=7)
|
4 participants
|
2 participants
|
1 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine RBC (n=17, n=14, n=15)
|
6 participants
|
3 participants
|
6 participants
|
|
RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria
High urine WBC (n=19, n=15, n=15)
|
6 participants
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Days 169, 197, 225, and 253Population: Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 169 SBP before infusion (n=39, n=35, n=44)
|
121.3 mm mercury (Hg)
Standard Deviation 15.81
|
116.6 mm mercury (Hg)
Standard Deviation 14.78
|
118.9 mm mercury (Hg)
Standard Deviation 13.32
|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 197 SBP before injection (n=40, n=35, n=43)
|
119.1 mm mercury (Hg)
Standard Deviation 14.07
|
118.4 mm mercury (Hg)
Standard Deviation 15.62
|
121.0 mm mercury (Hg)
Standard Deviation 14.45
|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 225 SBP before injection (n=40, n=35, n=42)
|
117.8 mm mercury (Hg)
Standard Deviation 14.19
|
118.8 mm mercury (Hg)
Standard Deviation 16.55
|
121.0 mm mercury (Hg)
Standard Deviation 16.88
|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 253 SBP before injection (n=40, 35, n=43)
|
118.3 mm mercury (Hg)
Standard Deviation 15.00
|
116.1 mm mercury (Hg)
Standard Deviation 14.86
|
120.3 mm mercury (Hg)
Standard Deviation 16.01
|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 169 DBP before infusion (n=39, n=35, n=44)
|
74.7 mm mercury (Hg)
Standard Deviation 10.46
|
73.5 mm mercury (Hg)
Standard Deviation 9.61
|
74.9 mm mercury (Hg)
Standard Deviation 9.15
|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 197 DBP before injection (n=40, n=35, n=43)
|
72.9 mm mercury (Hg)
Standard Deviation 9.24
|
71.6 mm mercury (Hg)
Standard Deviation 7.66
|
74.9 mm mercury (Hg)
Standard Deviation 9.51
|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 225 DBP before injection (n=40, n=35, n=42)
|
73.6 mm mercury (Hg)
Standard Deviation 10.56
|
73.7 mm mercury (Hg)
Standard Deviation 7.84
|
75.5 mm mercury (Hg)
Standard Deviation 10.65
|
|
RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III
Day 253 DBP before injection (n=40, n=35, n=44)
|
74.7 mm mercury (Hg)
Standard Deviation 11.24
|
71.5 mm mercury (Hg)
Standard Deviation 9.92
|
76.3 mm mercury (Hg)
Standard Deviation 11.02
|
SECONDARY outcome
Timeframe: Days 169, 197, 225, and 253Population: Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI Period; Mean Heart Rate (HR) During Period III
Day 169 HR before infusion (n=40, n=35, n=44)
|
73.4 beats per minute (bpm)
Standard Deviation 8.54
|
73.8 beats per minute (bpm)
Standard Deviation 10.13
|
74.1 beats per minute (bpm)
Standard Deviation 9.35
|
|
RI Period; Mean Heart Rate (HR) During Period III
Day 197 HR before injection (n=40, n=35, n=43)
|
73.1 beats per minute (bpm)
Standard Deviation 7.52
|
75.1 beats per minute (bpm)
Standard Deviation 7.25
|
70.9 beats per minute (bpm)
Standard Deviation 8.87
|
|
RI Period; Mean Heart Rate (HR) During Period III
Day 225 HR before injection (n=40, n=35, n=42)
|
73.2 beats per minute (bpm)
Standard Deviation 7.0
|
73.9 beats per minute (bpm)
Standard Deviation 7.43
|
73.2 beats per minute (bpm)
Standard Deviation 7.60
|
|
RI Period; Mean Heart Rate (HR) During Period III
Day 253 HR before injection (n=40, n=35, n=43)
|
73.6 beats per minute (bpm)
Standard Deviation 8.53
|
74.4 beats per minute (bpm)
Standard Deviation 7.87
|
74.3 beats per minute (bpm)
Standard Deviation 9.36
|
SECONDARY outcome
Timeframe: Days 169, 197, 225, and 253Population: Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
RI Period; Mean Temperature (T) During Period III
Day 169 T before infusion (n=40, n=35, n=44)
|
36.32 degrees Celsius
Standard Deviation 0.423
|
36.29 degrees Celsius
Standard Deviation 0.473
|
36.26 degrees Celsius
Standard Deviation 0.396
|
|
RI Period; Mean Temperature (T) During Period III
Day 197 T before injection (n=40, n=35, n=43)
|
36.39 degrees Celsius
Standard Deviation 0.405
|
36.37 degrees Celsius
Standard Deviation 0.424
|
36.35 degrees Celsius
Standard Deviation 0.354
|
|
RI Period; Mean Temperature (T) During Period III
Day 225 T before injection (n=40, n=35, n=42)
|
36.27 degrees Celsius
Standard Deviation 0.375
|
36.38 degrees Celsius
Standard Deviation 0.444
|
36.36 degrees Celsius
Standard Deviation 0.320
|
|
RI Period; Mean Temperature (T) During Period III
Day 253 T before injection (n=40, n=34, n=42)
|
36.28 degrees Celsius
Standard Deviation 0.473
|
36.32 degrees Celsius
Standard Deviation 0.587
|
36.33 degrees Celsius
Standard Deviation 0.383
|
SECONDARY outcome
Timeframe: Day 197 through Day 253Population: Participants treated during the RI Period with at least 1 immunogenicity result (ELISA) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ELISA.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups
Day 197 seropositive (n=2, n=1, n=1)
|
39.17 ug/mL
Standard Deviation 10.510
|
33.73 ug/mL
Standard Deviation NA
Standard deviation not applicable for 1 participant.
|
18.05 ug/mL
Standard Deviation NA
Standard deviation not applicable for 1 participant.
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups
Day 197 seronegative (n=33, n=32, n=40)
|
34.45 ug/mL
Standard Deviation 10.578
|
35.67 ug/mL
Standard Deviation 10.365
|
22.76 ug/mL
Standard Deviation 8.740
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups
Day 225 seropositive (n=0, n=1, n=1)
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
34.18 ug/mL
Standard Deviation NA
Standard deviation not applicable for 1 participant.
|
21.69 ug/mL
Standard Deviation NA
Standard deviation not applicable for 1 participant.
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups
Day 225 seronegative (n=36, n=29, n=41)
|
27.86 ug/mL
Standard Deviation 9.514
|
31.70 ug/mL
Standard Deviation 10.635
|
29.24 ug/mL
Standard Deviation 13.897
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups
Day 253 seropositive (n=1, n=0, n=2)
|
29.49 ug/mL
Standard Deviation NA
Standard deviation no applicable for 1 participant.
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
26.23 ug/mL
Standard Deviation 0.776
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups
Day 253 seronegative (n=34, n=30, n=39)
|
30.17 ug/mL
Standard Deviation 9.856
|
28.26 ug/mL
Standard Deviation 10.211
|
26.80 ug/mL
Standard Deviation 10.547
|
SECONDARY outcome
Timeframe: Day 197 through Day 253Population: Participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ECL.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=35 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
n=44 Participants
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups
Day 197 seropositive (n=0, n=0, n=0)
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups
Day 197 seronegative (n=35, n=33, n=41)
|
34.72 ug/mL
Standard Deviation 10.479
|
35.61 ug/mL
Standard Deviation 10.207
|
22.65 ug/mL
Standard Deviation 8.662
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups
Day 225 seropositive (n=0, n=0, n=0)
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups
Day 225 seronegative (n=36, n=30, n=42)
|
27.86 ug/mL
Standard Deviation 9.514
|
31.79 ug/mL
Standard Deviation 10.460
|
29.06 ug/mL
Standard Deviation 13.776
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups
Day 253 seropositive (n=0, n=0, n=0)
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
NA ug/mL
Standard Deviation NA
Data not measured/analyzed for 0 participants.
|
|
Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups
Day 253 seronegative (n=36, n=30, n=42\)
|
29.75 ug/mL
Standard Deviation 9.872
|
28.26 ug/mL
Standard Deviation 10.211
|
26.28 ug/mL
Standard Deviation 10.645
|
SECONDARY outcome
Timeframe: Baseline, Day 253Population: Participants treated in DBW period with at least 1 immunogenicity result (immunofluorescence, radioimmunoassay, or immunoturbidimetry) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point
Venous blood was collected and tested for anti-nuclear antibodies, anti-dsDNA antibodies, and rheumatoid factor. ANA were detected by means of immunofluorescent antibodies. An anti-DNA radioimmunoassay was used for detection of anti-dsDNA antibodies (Diagnostic Products Corporation). RF was measured by an immunoturbidimetric assay (Roche Tina-Quant). Determinations of antibody or RF status were made at baseline and Day 253.
Outcome measures
| Measure |
Abatacept in DBW Period
n=40 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=79 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups
BL dsDNA positive (n=3, n=6)
|
2 participants
|
3 participants
|
—
|
|
ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups
BL ANA negative (n=27, n=57)
|
1 participants
|
3 participants
|
—
|
|
ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups
BL ANA positive (n=11, 18)
|
5 participants
|
10 participants
|
—
|
|
ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups
BL dsDNA negative (n=33, n=63)
|
1 participants
|
2 participants
|
—
|
|
ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups
BL RF negative (n=6, n=10)
|
0 participants
|
0 participants
|
—
|
|
ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups
BL RF positive (n=34, n=64)
|
34 participants
|
63 participants
|
—
|
SECONDARY outcome
Timeframe: For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.Population: The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n=number of participants with both baseline and post-baseline measurements.
DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. DAS28-CRP has numeric thresholds defining high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169.
Outcome measures
| Measure |
Abatacept in DBW Period
n=36 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 15; Treatment Day 15 (n=31, 106)
|
-0.48 units on a scale
Standard Error 0.14
|
-0.79 units on a scale
Standard Error 0.06
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 85; Treatment Day 85 (n=36, 112)
|
-0.35 units on a scale
Standard Error 0.21
|
-1.91 units on a scale
Standard Error 0.09
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 253; Treatment Day 85 (n=0, n=109)
|
NA units on a scale
Standard Error NA
No data collected. 0 participants available. Period 1 non-responders started LTE on Study Day 85, not Study Day 253.
|
-2.29 units on a scale
Standard Error 0.09
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 337; Treatment Day 169 (n=34,n=113)
|
-1.51 units on a scale
Standard Error 0.16
|
-2.34 units on a scale
Standard Error 0.09
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 365; Treatment Day 197 (n=31, n=110)
|
-1.83 units on a scale
Standard Error 0.19
|
-2.23 units on a scale
Standard Error 0.10
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 533; Treatment Day 365 (n=32, n=106)
|
-1.86 units on a scale
Standard Error 0.19
|
-2.28 units on a scale
Standard Error 0.12
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 729; Treatment Day 561 (n=30, n=106
|
-1.81 units on a scale
Standard Error 0.19
|
-2.16 units on a scale
Standard Error 0.12
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 1093; Treatment Day 925 (n=26, n=98)
|
-1.94 units on a scale
Standard Error 0.18
|
-2.12 units on a scale
Standard Error 0.12
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 1261; Treatment Day 1093 (n=25, n=96)
|
-1.70 units on a scale
Standard Error 0.15
|
-2.20 units on a scale
Standard Error 0.13
|
—
|
|
LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE
Study Day 1821; Treatment Day 1653 (n=20, n=67)
|
-1.86 units on a scale
Standard Error 0.20
|
-2.55 units on a scale
Standard Error 0.14
|
—
|
SECONDARY outcome
Timeframe: For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821Population: The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n= number of participants evaluated at each specific timepoint
DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. Clinical remission=DAS28-CRP score\<2.6. Percent=Number of participants meeting remission divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available (NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169.
Outcome measures
| Measure |
Abatacept in DBW Period
n=36 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE
Study Day 85 (n=36, n=112)
|
11.1 percentage of participants
|
36.6 percentage of participants
|
—
|
|
LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE
Study Day 253 (n=0, n=109)
|
NA percentage of participants
no data available. 0 participants. Period 1 non-responders entered LTE on Study Day 85, not Study Day 253.
|
59.6 percentage of participants
|
—
|
|
LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE
Study Day 337 (n=34, n=113)
|
50.0 percentage of participants
|
59.3 percentage of participants
|
—
|
|
LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE
Study Day 729 (n=30, n=106)
|
53.3 percentage of participants
|
54.7 percentage of participants
|
—
|
|
LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE
Study Day 1093 (n=26, 90)
|
73.1 percentage of participants
|
51.0 percentage of participants
|
—
|
|
LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE
Study Day 1261 (n=25, n=96)
|
48.0 percentage of participants
|
59.4 percentage of participants
|
—
|
|
LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE
Study Day 1821 (n=20, n=67)
|
60.0 percentage of participants
|
59.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.Population: The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1.
DAS28:continuous disease measure composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. Low disease activity score: ≤ 3.2. Percent=Number of participants with Low Disease Activity divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169.
Outcome measures
| Measure |
Abatacept in DBW Period
n=36 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE
Study Day 85 (n=36, n=112)
|
27.8 percentage of participants
|
66.1 percentage of participants
|
—
|
|
LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE
Study Day 253 (n=0, n=109)
|
NA percentage of participants
no data available. 0 participants. Period 1 non-responders entered LTE on Study Day 85, not Study Day 253.
|
75.2 percentage of participants
|
—
|
|
LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE
Study Day 337 (n=34, n=113)
|
67.6 percentage of participants
|
76.1 percentage of participants
|
—
|
|
LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE
Study Day 729 (n=30, n=106)
|
73.3 percentage of participants
|
73.6 percentage of participants
|
—
|
|
LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE
Study Day 1093 (n=26, n=98)
|
80.8 percentage of participants
|
67.3 percentage of participants
|
—
|
|
LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE
Study Day 1261 (n=25, n=96)
|
68.0 percentage of participants
|
75.0 percentage of participants
|
—
|
|
LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE
Study Day 1821 (n=20, n=67)
|
80.0 percentage of participants
|
88.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073Population: The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were non-responders at the end of Period 1. n= number of participants with data who were evaluated
The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index (DI) was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ DI. Percent=number of participants with HAQ response divided by number of participants in the analysis. Since Period I Non-responders proceeded directly to the LTE at the end of Period I (Day 85), study days do not represent treatment days.
Outcome measures
| Measure |
Abatacept in DBW Period
n=37 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 15; Treatment Day 15 (n=34, n=110)
|
20.6 percentage of participants
Interval 7.0 to 34.2
|
44.5 percentage of participants
Interval 35.3 to 53.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 29; Treatment Day 29 (n=36, n=113)
|
27.8 percentage of participants
Interval 13.1 to 42.4
|
56.6 percentage of participants
Interval 47.5 to 65.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 57; Treatment Day 57 (n=36, n=112)
|
44.4 percentage of participants
Interval 28.2 to 60.7
|
64.3 percentage of participants
Interval 55.4 to 73.2
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 78; Treatment Day 78 (n=34, n=103)
|
41.2 percentage of participants
Interval 24.6 to 57.7
|
68.0 percentage of participants
Interval 58.9 to 77.0
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 85; Treatment Day 85 (n=37, n=112)
|
40.5 percentage of participants
Interval 24.7 to 56.4
|
74.1 percentage of participants
Interval 66.0 to 82.2
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 253; Treatment Day 85 (n=0, n=109)
|
NA percentage of participants
no data collected. 0 participants. Period 1 non-responders entered LTE on Study Day 85 not Study Day 253.
|
78.0 percentage of participants
Interval 70.2 to 85.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 337; Treatment Day 169 (n=34, n=113)
|
50.0 percentage of participants
Interval 33.2 to 66.8
|
79.6 percentage of participants
Interval 72.2 to 87.1
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 365; Treatment Day 197 (n=32, n=111)
|
53.1 percentage of participants
Interval 35.8 to 70.4
|
78.4 percentage of participants
Interval 70.7 to 86.0
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 449; Treatment Day 281 (n=32, n=109)
|
56.3 percentage of participants
Interval 39.1 to 73.4
|
73.4 percentage of participants
Interval 65.1 to 81.7
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 533; Treatment Day 365 (n=32, n=108)
|
59.4 percentage of participants
Interval 42.4 to 76.4
|
72.2 percentage of participants
Interval 63.8 to 80.7
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 617; Treatment Day 449 (n=31, n=107)
|
54.8 percentage of participants
Interval 37.3 to 72.4
|
70.1 percentage of participants
Interval 61.4 to 78.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 729; Treatment Day 561 (n=30, n=107)
|
60.0 percentage of participants
Interval 42.5 to 77.5
|
70.1 percentage of participants
Interval 61.4 to 78.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 813; Treatment Day 645 (n=30, n=106)
|
53.3 percentage of participants
Interval 35.5 to 71.2
|
71.7 percentage of participants
Interval 63.1 to 80.3
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 897; Treatment Day 729 (n=30, n=103)
|
50.0 percentage of participants
Interval 32.1 to 67.9
|
76.7 percentage of participants
Interval 68.5 to 84.9
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 981; Treatment Day 813 (n=29, n=100)
|
44.8 percentage of participants
Interval 26.7 to 62.9
|
73.0 percentage of participants
Interval 64.3 to 81.7
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1093; Treatment Day 925 (n=28, n=99)
|
50.0 percentage of participants
Interval 31.5 to 68.5
|
73.7 percentage of participants
Interval 65.1 to 82.4
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1177; Treatment Day 1009 (n=26, n=99)
|
61.5 percentage of participants
Interval 42.8 to 80.2
|
68.7 percentage of participants
Interval 59.6 to 77.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1261; Treatment Day 1093 (n=25, n=97)
|
60.0 percentage of participants
Interval 40.8 to 79.2
|
70.1 percentage of participants
Interval 61.0 to 79.2
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1345; Treatment Day 1177 (n=25, n=89)
|
64.0 percentage of participants
Interval 45.2 to 82.8
|
70.8 percentage of participants
Interval 61.3 to 80.2
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1457; Treatment Day 1289 (n=24, n=79)
|
66.7 percentage of participants
Interval 47.8 to 85.5
|
72.2 percentage of participants
Interval 62.3 to 82.0
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1541; Treatment Day 1373 (n=21, n=75)
|
61.9 percentage of participants
Interval 41.1 to 82.7
|
69.3 percentage of participants
Interval 58.9 to 79.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1625; Treatment Day 1457 (n=21, n=73)
|
52.4 percentage of participants
Interval 31.0 to 73.7
|
74.0 percentage of participants
Interval 63.9 to 84.0
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1709; Treatment Day 1541 (n=20, n=71)
|
60.0 percentage of participants
Interval 38.5 to 81.5
|
74.6 percentage of participants
Interval 64.5 to 84.8
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1821; Treatment Day 1653 (n=20, n=68)
|
65.0 percentage of participants
Interval 44.1 to 85.9
|
73.5 percentage of participants
Interval 63.0 to 84.0
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1905; Treatment Day 1737 (n=19, n=5)
|
63.2 percentage of participants
Interval 41.5 to 84.8
|
80.0 percentage of participants
Interval 44.9 to 100.0
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 1989; Treatment Day 1821 (n=19, n=0)
|
68.4 percentage of participants
Interval 47.5 to 89.3
|
NA percentage of participants
no data collected due to 0 participant available.
|
—
|
|
LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE
Study Day 2073; Treatment Day 1905 (n=5, n=0)
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
NA percentage of participants
no data collected due to 0 participant available.
|
—
|
SECONDARY outcome
Timeframe: Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTEPopulation: All participants treated in LTE period with at least 1 immunogenicity result (ECL) during LTE period. n=number of participants evaluated.
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using electrochemiluminescence (ECL). The percent of participants with a positive abatacept induced immunogenicity response against cytotoxic T-lymphocyte antigen 4 (CTLA4) and possibly immunoglobulin (Ig), or against Ig and/or Junction Region was calculated by number of participants with a positive response divided by number of participants evaluated. Overall for on-treatment includes treatment visits on Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, and 1989.
Outcome measures
| Measure |
Abatacept in DBW Period
n=149 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE
Overall Study (n=149)
|
20.1 percentage of participants
|
—
|
—
|
|
LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE
Overall on Treatment Visit Days (n=147)
|
15.6 percentage of participants
|
—
|
—
|
|
LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE
28 Days post last dose (n=110)
|
7.3 percentage of participants
|
—
|
—
|
|
LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE
56 Days post last dose (n=16)
|
6.3 percentage of participants
|
—
|
—
|
|
LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE
85 Days post last dose (n=103)
|
7.8 percentage of participants
|
—
|
—
|
|
LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE
168 Days post last dose (n=21)
|
23.8 percentage of participants
|
—
|
—
|
|
LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE
Overall Post Visits (n=126)
|
12.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.Population: Participants who received at least 1 dose of study medication in LTE period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. SAEs include hospitalizations for elective surgical procedures.All deaths reported during the LTE including those that occurred \> 56 days after the last dose. Related AE or SAE defined as AE or SAE with Certain, Probable, Possible, or Missing relationship to study medication. All participants who completed the ST period could enter the open label LTE on Day 253; LI Period 1 non-responders could directly enter the LTE.
Outcome measures
| Measure |
Abatacept in DBW Period
n=37 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)
Deaths
|
1 participants
|
6 participants
|
—
|
|
LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)
Related SAEs
|
0 participants
|
3 participants
|
—
|
|
LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)
SAEs Leading to Discontinuation
|
1 participants
|
5 participants
|
—
|
|
LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)
Related AEs
|
9 participants
|
45 participants
|
—
|
|
LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)
AEs Leading to Discontinuation
|
2 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.Population: Participants who received at least 1 dose of study medication in LTE period
AEs of special interest in LTE are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies, local injection site reaction (pre-specified AEs occurring at the site of SC injection) and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)
Outcome measures
| Measure |
Abatacept in DBW Period
n=37 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Number of Participants With AEs of Special Interest During LTE
Infections and infestations
|
23 participants
|
78 participants
|
—
|
|
LTE: Number of Participants With AEs of Special Interest During LTE
Malignancies
|
1 participants
|
3 participants
|
—
|
|
LTE: Number of Participants With AEs of Special Interest During LTE
Autoimmune disorders (prespecified)
|
3 participants
|
8 participants
|
—
|
|
LTE: Number of Participants With AEs of Special Interest During LTE
Local injection site reactions (prespecified)
|
0 participants
|
3 participants
|
—
|
|
LTE: Number of Participants With AEs of Special Interest During LTE
Systemic injection reactions (prespecified)
|
3 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.Population: Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.
Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 cells/uL; eosinophils: \>0.750 \* 10\^3 cells/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 cells/uL/ \>7.50 \* 10\^3 cells/uL.
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
Low neutrophils+bands
|
0 participants
|
2 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
Low HGB
|
1 participants
|
4 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
Low hematocrit
|
0 participants
|
2 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
Low erythrocytes
|
0 participants
|
1 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
Low PLT
|
0 participants
|
1 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
Low leukocytes
|
1 participants
|
5 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
High leukocytes
|
0 participants
|
6 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
High eosinophils
|
3 participants
|
14 participants
|
—
|
|
LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE
Low lymphocytes
|
5 participants
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.Population: Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE
High AST
|
0 participants
|
3 participants
|
—
|
|
LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE
High ALT
|
2 participants
|
2 participants
|
—
|
|
LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE
High GGT
|
1 participants
|
8 participants
|
—
|
|
LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE
High bilirubin
|
0 participants
|
1 participants
|
—
|
|
LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE
High BUN
|
0 participants
|
7 participants
|
—
|
|
LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE
High creatinine
|
4 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.Population: Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.
Marked abnormality criteria: Sodium (Na): \<0.95\*LLN/ \>1.05\*ULN, or if BL\<LLN then use \<0.95\* BL or \>ULN, or if BL\>ULN then use\>1.05\* BL or \<LLN; potassium (K): \<0.9\* LLN/\>1.1\*ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; (Cl): \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; calcium (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use \<0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE
High Na
|
1 participants
|
0 participants
|
—
|
|
LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE
Low K
|
0 participants
|
3 participants
|
—
|
|
LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE
High Cl
|
1 participants
|
0 participants
|
—
|
|
LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE
Low P
|
0 participants
|
5 participants
|
—
|
|
LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE
High P
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.Population: Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the LTE period.
MA criteria: serum glucose (Glu): \<65 mg/dL/\>220 mg/dL;fasting serum Glu: \<0.8\* LLN/\>1.5\*ULN,or if BL\<LLN then use 0.8\*BL or \>ULN,or if BL\>ULN then use \>2.0\*BL or \<LLN;total protein: \<0.9\*LLN/\>1.1\*ULN,or if BL\<LLN then use \<0.9\*BL or \>UNL,or if BL\>UNL then use \>1.1\*BL or \<LLN; albumin: \<0.9\*LLN,or if BL\<LLN then use \<0.75 BL;uric acid: \>1.5\*ULN,or if BL\>ULN then use \>2\*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=113 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
Low Glu (n=35, n=113)
|
6 participants
|
16 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High Glu (n=35, n=113)
|
1 participants
|
6 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
Low fasting Glu (n=14, n=75)
|
4 participants
|
2 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High fasting Glu (n=14, n=75)
|
0 participants
|
6 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
Low total protein (n=35, n=113)
|
1 participants
|
0 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
Low albumin (n=35, n=113)
|
1 participants
|
0 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High urine protein (n=35, n=113)
|
2 participants
|
11 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High urine Glu (n=35, n=113)
|
1 participants
|
3 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High urine blood (n=35, n=113)
|
5 participants
|
30 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High urine WBC (n=22, n=81)
|
12 participants
|
39 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High urine RBC (n=16, n=66)
|
1 participants
|
27 participants
|
—
|
|
LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE
High leukocyte esterase (n=19, n=67)
|
6 participants
|
18 participants
|
—
|
SECONDARY outcome
Timeframe: Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073Population: Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=110 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 337 (n=35, n=110)
|
125.7 mm Hg
Standard Deviation 13.76
|
120.8 mm Hg
Standard Deviation 15.92
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 365 (n=32, n=108)
|
122.7 mm Hg
Standard Deviation 14.26
|
120.4 mm Hg
Standard Deviation 15.11
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 449 (n=32, n=108)
|
122.9 mm Hg
Standard Deviation 15.08
|
119.5 mm Hg
Standard Deviation 14.88
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 533 (n=32, n=108)
|
123.0 mm Hg
Standard Deviation 14.48
|
120.7 mm Hg
Standard Deviation 15.75
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 617 (n= 30, n=107)
|
121.7 mm Hg
Standard Deviation 13.26
|
118.7 mm Hg
Standard Deviation 15.30
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 729 (n=30, n=106)
|
122.2 mm Hg
Standard Deviation 11.77
|
121.5 mm Hg
Standard Deviation 17.41
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 813 (n=30, n=101)
|
126.6 mm Hg
Standard Deviation 12.66
|
120.6 mm Hg
Standard Deviation 15.65
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 897 (n=30, n=102)
|
123.9 mm Hg
Standard Deviation 11.92
|
122.5 mm Hg
Standard Deviation 14.92
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 981 (n=28, n=100)
|
123.3 mm Hg
Standard Deviation 12.23
|
122.9 mm Hg
Standard Deviation 15.03
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1093 (n=26, n=99)
|
127.2 mm Hg
Standard Deviation 18.41
|
123.7 mm Hg
Standard Deviation 15.11
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1177 (n=25, n=96)
|
125.8 mm Hg
Standard Deviation 11.17
|
123.0 mm Hg
Standard Deviation 15.96
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1261 (n=25, n=92)
|
124.9 mm Hg
Standard Deviation 11.04
|
119.7 mm Hg
Standard Deviation 13.64
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1345 (n=24, n=82)
|
124.5 mm Hg
Standard Deviation 13.11
|
121.9 mm Hg
Standard Deviation 14.49
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1457 (n=21, n=79)
|
124.1 mm Hg
Standard Deviation 14.75
|
125.5 mm Hg
Standard Deviation 18.41
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1541 (n=21, n=79)
|
126.1 mm Hg
Standard Deviation 15.06
|
122.3 mm Hg
Standard Deviation 14.53
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1709 (n=21, n=74)
|
123.0 mm Hg
Standard Deviation 13.08
|
121.9 mm Hg
Standard Deviation 14.90
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1821 (n=20, n=33)
|
125.4 mm Hg
Standard Deviation 13.22
|
124.3 mm Hg
Standard Deviation 10.95
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1905 (n=18, n=0)
|
121.8 mm Hg
Standard Deviation 13.14
|
NA mm Hg
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1989 (n=13, n=0)
|
124.6 mm Hg
Standard Deviation 9.56
|
NA mm Hg
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 2073 (n=1, n=0)
|
113.0 mm Hg
Standard Deviation 0
|
NA mm Hg
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE
Day 1625 (n=21, n=77)
|
122.4 mm Hg
Standard Deviation 9.09
|
120.3 mm Hg
Standard Deviation 13.76
|
—
|
SECONDARY outcome
Timeframe: Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073Population: Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=110 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 337 (n=35, 110)
|
76.3 mmHg
Standard Deviation 6.69
|
75.4 mmHg
Standard Deviation 11.18
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 365 (n=32, 108)
|
75.1 mmHg
Standard Deviation 10.42
|
75.1 mmHg
Standard Deviation 8.94
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 449 (n=32, n=108)
|
77.3 mmHg
Standard Deviation 9.48
|
73.8 mmHg
Standard Deviation 9.12
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 533 (n=32, n=108)
|
75.5 mmHg
Standard Deviation 8.43
|
75.4 mmHg
Standard Deviation 9.14
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 617 (n=30, n=107)
|
74.2 mmHg
Standard Deviation 8.81
|
74.8 mmHg
Standard Deviation 9.45
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 729 (n=30, n=106)
|
73.2 mmHg
Standard Deviation 8.42
|
76.1 mmHg
Standard Deviation 9.86
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 813 (n=30, n=101)
|
75.7 mmHg
Standard Deviation 9.39
|
76.4 mmHg
Standard Deviation 9.30
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 897 (n=30, n=102)
|
76.8 mmHg
Standard Deviation 8.41
|
75.5 mmHg
Standard Deviation 9.09
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 981 (n=28, n=100)
|
77.4 mmHg
Standard Deviation 6.55
|
76.1 mmHg
Standard Deviation 9.67
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1093 (n=26, n=99)
|
76.7 mmHg
Standard Deviation 7.11
|
75.9 mmHg
Standard Deviation 9.88
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1177 (n=25, n=96)
|
76.3 mmHg
Standard Deviation 6.32
|
75.9 mmHg
Standard Deviation 8.58
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1261 (n=25, n=92)
|
75.4 mmHg
Standard Deviation 8.18
|
75.6 mmHg
Standard Deviation 8.59
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1345 (n=24, n=82)
|
75.3 mmHg
Standard Deviation 6.08
|
75.6 mmHg
Standard Deviation 9.03
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1457 (n=21, n=79)
|
75.6 mmHg
Standard Deviation 9.18
|
77.1 mmHg
Standard Deviation 10.04
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1541 (n=21, n=79)
|
76.9 mmHg
Standard Deviation 8.14
|
76.0 mmHg
Standard Deviation 9.15
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1625 (n=21, n=77)
|
77.2 mmHg
Standard Deviation 5.89
|
74.9 mmHg
Standard Deviation 9.01
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1709 (n=21, n=74)
|
75.0 mmHg
Standard Deviation 9.47
|
75.4 mmHg
Standard Deviation 9.09
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day1821 (n=20, n=33)
|
76.0 mmHg
Standard Deviation 7.99
|
78.3 mmHg
Standard Deviation 7.57
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1905 (n=18, n=0)
|
73.2 mmHg
Standard Deviation 7.96
|
NA mmHg
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 1989 (n=13, n=0)
|
77.0 mmHg
Standard Deviation 5.31
|
NA mmHg
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE
Day 2073 (n=1, n=0)
|
69.0 mmHg
Standard Deviation 0
|
NA mmHg
Standard Deviation NA
No participants; n=0
|
—
|
SECONDARY outcome
Timeframe: Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073Population: Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
During LTE, heart rate was taken in participants while seated, measured in beats per minute (bpm) and was assessed at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=110 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Mean Heart Rate (HR) During LTE
Day 337 (n=35, n=110)
|
74.3 bpm
Standard Deviation 7.07
|
74.9 bpm
Standard Deviation 8.76
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 365 (n=32, n=109)
|
74.2 bpm
Standard Deviation 7.76
|
75.7 bpm
Standard Deviation 8.45
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 449 (n=32, n=108)
|
74.4 bpm
Standard Deviation 6.62
|
75.7 bpm
Standard Deviation 7.76
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 533 (n=32, n=108)
|
75.8 bpm
Standard Deviation 6.62
|
74.7 bpm
Standard Deviation 8.32
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 617 (n=30, n=107)
|
75.7 bpm
Standard Deviation 6.96
|
76.0 bpm
Standard Deviation 8.35
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 729 (n=30, n=106)
|
74.2 bpm
Standard Deviation 8.60
|
75.1 bpm
Standard Deviation 8.70
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 813 (n=30, n=103)
|
72.4 bpm
Standard Deviation 7.57
|
76.2 bpm
Standard Deviation 9.23
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 897 (n=30, n=102)
|
76.1 bpm
Standard Deviation 7.71
|
76.3 bpm
Standard Deviation 8.15
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 981 (n=28, n=100)
|
74.4 bpm
Standard Deviation 8.00
|
76.5 bpm
Standard Deviation 10.75
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1093 (n=26, n=99)
|
76.3 bpm
Standard Deviation 8.35
|
75.0 bpm
Standard Deviation 9.20
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1177 (n=25, n=97)
|
77.6 bpm
Standard Deviation 6.89
|
75.3 bpm
Standard Deviation 9.00
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1261 (n=25, n=92)
|
75.7 bpm
Standard Deviation 7.97
|
74.4 bpm
Standard Deviation 8.91
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1345 (n=24, n=82)
|
73.5 bpm
Standard Deviation 8.54
|
73.6 bpm
Standard Deviation 8.62
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1457 (n=21, n=79)
|
75.0 bpm
Standard Deviation 7.67
|
76.8 bpm
Standard Deviation 7.96
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1541 (n=21, n=79)
|
77.3 bpm
Standard Deviation 7.34
|
75.1 bpm
Standard Deviation 8.51
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1625 (n=21, n=77)
|
76.9 bpm
Standard Deviation 7.77
|
75.2 bpm
Standard Deviation 8.12
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1709 (n=21, n=74)
|
78.7 bpm
Standard Deviation 6.86
|
74.7 bpm
Standard Deviation 8.83
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1821 (n=20, n=33)
|
79.5 bpm
Standard Deviation 7.80
|
78.2 bpm
Standard Deviation 6.78
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1905 (n=18, n=0)
|
77.1 bpm
Standard Deviation 8.97
|
NA bpm
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 1989 (n= 13, n=0)
|
77.2 bpm
Standard Deviation 9.53
|
NA bpm
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Heart Rate (HR) During LTE
Day 2073 (n=1, n=0)
|
63.0 bpm
Standard Deviation 0
|
NA bpm
Standard Deviation NA
No participants; n=0
|
—
|
SECONDARY outcome
Timeframe: Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073Population: Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.
During LTE, temperature was taken in participants while seated, measured in degrees celsius and was assessed at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.
Outcome measures
| Measure |
Abatacept in DBW Period
n=35 Participants
Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
|
Placebo in DBW Period
n=110 Participants
Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
|
PLA Switched to ABA With PLA IV Loading Dose [RI]
Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
|
|---|---|---|---|
|
LTE: Mean Temperature (T) During LTE
Day 337 (n=35, n=110)
|
36.29 degrees Celsius
Standard Deviation 0.285
|
36.31 degrees Celsius
Standard Deviation 0.370
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 365 (n=32, n=108)
|
36.35 degrees Celsius
Standard Deviation 0.370
|
36.30 degrees Celsius
Standard Deviation 0.393
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 449 (n=32, n=108)
|
36.40 degrees Celsius
Standard Deviation 0.354
|
36.30 degrees Celsius
Standard Deviation 0.294
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 533 (n=32, n=108)
|
36.42 degrees Celsius
Standard Deviation 0.358
|
36.30 degrees Celsius
Standard Deviation 0.312
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 617 (n=30, n=106)
|
36.38 degrees Celsius
Standard Deviation 0.248
|
36.37 degrees Celsius
Standard Deviation 0.316
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 729 (n=30, n=106)
|
36.47 degrees Celsius
Standard Deviation 0.252
|
36.27 degrees Celsius
Standard Deviation 0.332
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 813 (n=30, n=103)
|
36.49 degrees Celsius
Standard Deviation 0.284
|
36.30 degrees Celsius
Standard Deviation 0.324
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 897 (n=30, n=102)
|
36.44 degrees Celsius
Standard Deviation 0.254
|
36.26 degrees Celsius
Standard Deviation 0.325
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 981 (n=28, n=100)
|
36.48 degrees Celsius
Standard Deviation 0.259
|
36.30 degrees Celsius
Standard Deviation 0.295
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1093 (n=26, n=99)
|
36.35 degrees Celsius
Standard Deviation 0.370
|
36.28 degrees Celsius
Standard Deviation 0.278
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1177 (n=25, n=97)
|
36.41 degrees Celsius
Standard Deviation 0.277
|
36.24 degrees Celsius
Standard Deviation 0.327
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1261 (n=25, n=92)
|
36.39 degrees Celsius
Standard Deviation 0.256
|
36.24 degrees Celsius
Standard Deviation 0.276
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1345 (n=24,n=82)
|
36.29 degrees Celsius
Standard Deviation 0.285
|
36.23 degrees Celsius
Standard Deviation 0.232
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1457 (n=21, n=79)
|
36.32 degrees Celsius
Standard Deviation 0.253
|
36.23 degrees Celsius
Standard Deviation 0.242
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1541 (n=21, n=79)
|
36.34 degrees Celsius
Standard Deviation 0.223
|
36.24 degrees Celsius
Standard Deviation 0.198
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1625 (n=21, n=77)
|
36.37 degrees Celsius
Standard Deviation 0.215
|
36.20 degrees Celsius
Standard Deviation 0.214
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1709 (n=21, n=74)
|
36.35 degrees Celsius
Standard Deviation 0.178
|
36.24 degrees Celsius
Standard Deviation 0.249
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1821 (n=20, n=33)
|
36.25 degrees Celsius
Standard Deviation 0.315
|
36.26 degrees Celsius
Standard Deviation 0.228
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1905 (n=18, n=0)
|
36.37 degrees Celsius
Standard Deviation 0.211
|
NA degrees Celsius
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 1989 (n=13, n=0)
|
36.35 degrees Celsius
Standard Deviation 0.139
|
NA degrees Celsius
Standard Deviation NA
No participants; n=0
|
—
|
|
LTE: Mean Temperature (T) During LTE
Day 2073 (n=1, n=0)
|
36.40 degrees Celsius
Standard Deviation 0
|
NA degrees Celsius
Standard Deviation NA
No participants; n=0
|
—
|
Adverse Events
Period 1 Non-Completers
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Period 1 Non-Responders
Serious events: 12 serious events
Other events: 29 other events
Deaths: 0 deaths
Abatacept Received in Period 2
Serious events: 11 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo Received in Period 2
Serious events: 27 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1 Non-Completers
n=10 participants at risk
Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. These participants did not complete the Period and did not continue in the study.
|
Period 1 Non-Responders
n=37 participants at risk
Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 until completion of the LTE.
|
Abatacept Received in Period 2
n=40 participants at risk
Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Abatacept SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were continued in Reintroduction Period 3 and during the LTE Period until completion of the LTE.
|
Placebo Received in Period 2
n=80 participants at risk
Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Placebo SC injections starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were administered during Reintroduction Period 3 and during the LTE Period until completion of the LTE.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
General disorders
Sudden death
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
General disorders
Chest pain
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
Other adverse events
| Measure |
Period 1 Non-Completers
n=10 participants at risk
Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. These participants did not complete the Period and did not continue in the study.
|
Period 1 Non-Responders
n=37 participants at risk
Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 until completion of the LTE.
|
Abatacept Received in Period 2
n=40 participants at risk
Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Abatacept SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were continued in Reintroduction Period 3 and during the LTE Period until completion of the LTE.
|
Placebo Received in Period 2
n=80 participants at risk
Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Placebo SC injections starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were administered during Reintroduction Period 3 and during the LTE Period until completion of the LTE.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
6/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
6.2%
5/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Streptococcal infection
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
29.7%
11/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
22.5%
9/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
22.5%
18/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
6/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
10.0%
4/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
6.2%
5/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
37.8%
14/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
30.0%
12/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
22.5%
18/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
8.1%
3/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
6/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
24.3%
9/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
12.5%
5/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
17.5%
14/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
8.1%
3/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
8.8%
7/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
6.2%
5/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
8.1%
3/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
12.5%
10/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Nervous system disorders
Sinus headache
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
6.2%
5/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
6.2%
5/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
16.2%
6/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
15.0%
6/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
20.0%
16/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
10.8%
4/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
8.8%
7/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
12.5%
5/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
6/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Staphylococcal infection
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
15.0%
6/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
6/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
2/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.7%
1/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
2.5%
1/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
8.8%
7/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
4/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.4%
2/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
5.0%
2/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
1.2%
1/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
10.8%
4/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
15.0%
6/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
10.0%
8/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
0.00%
0/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
7.5%
3/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
3.8%
3/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
16.2%
6/37 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
25.0%
10/40 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
18.8%
15/80 • Day 1 up to 56 days post last dose, through LTE (for those participating in LTE); Day 1 up to 56 days post last dose until final day of study for Period 1 non-completers.
Study initiated November 2007 and LTE ended February 2014. Periods 1, 2, 3 were each 12 weeks in length. LTE started Day 253 and continued until abatacept was approved by the respective country and commercially available or until the sponsor elected to terminate the study.
|
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