Trial Outcomes & Findings for Phase IIIB Subcutaneous Abatacept Monotherapy Study (NCT NCT00547521)

NCT ID: NCT00547521

Last Updated: 2015-03-23

Results Overview

ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 119 participants
• Primary outcome timeframe: Day 113
• Results posted on: 2015-03-23

Participant Flow

Short term (ST) Study results (2 arms) were released in 2010. Final long term extension (LTE) results (1 arm with pooled data), up to 2014, are now included. During the LTE Study, 125 mg abatacept, was continued to be self-administered weekly and adjustments to RA medications including MTX were permitted at investigators discretion.

119 participants enrolled;100 treated in the ST Study. Reasons not treated: 17 no longer met criteria, 2 withdrew consent. 96 completed ST treatment but only 95 completed Primary endpoint evaluation. 90 enrolled in LTE Study. Reasons why participants did not enroll in LTE Study: 2 lack of efficacy, 2 had adverse events, 1 no longer met criteria.

Participant milestones

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Cohort In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
Short Term Study (4 Months) STARTED	51	49
Short Term Study (4 Months) COMPLETED	50	45
Short Term Study (4 Months) NOT COMPLETED	1	4
Long Term Extension (LTE) Study STARTED	0	90
Long Term Extension (LTE) Study COMPLETED	0	59
Long Term Extension (LTE) Study NOT COMPLETED	0	31

Reasons for withdrawal

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Cohort In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
Short Term Study (4 Months) Adverse Event	1	0
Short Term Study (4 Months) Lack of Efficacy	0	2
Short Term Study (4 Months) Withdrawal of consent	0	1
Short Term Study (4 Months) primary endpoint evaluation not complete	0	1
Long Term Extension (LTE) Study Lack of Efficacy	0	14
Long Term Extension (LTE) Study Adverse Event	0	9
Long Term Extension (LTE) Study Lost to Follow-up	0	3
Long Term Extension (LTE) Study Withdrawal by Subject	0	2
Long Term Extension (LTE) Study Other	0	2
Long Term Extension (LTE) Study Poor/Non-Compliance	0	1

Baseline Characteristics

Phase IIIB Subcutaneous Abatacept Monotherapy Study

Baseline characteristics by cohort

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.	Total n=100 Participants Total of all reporting groups
Age, Continuous	55.0 years FULL_RANGE 11.5 • n=5 Participants	54.0 years FULL_RANGE 10.2 • n=7 Participants	54.0 years FULL_RANGE 10.9 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	41 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized White	42 participants n=5 Participants	34 participants n=7 Participants	76 participants n=5 Participants
Race/Ethnicity, Customized Black	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	10 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized Other races	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Weight continuous	84.6 kilogram (Kg) STANDARD_DEVIATION 18.8 • n=5 Participants	81.6 kilogram (Kg) STANDARD_DEVIATION 22.4 • n=7 Participants	83.1 kilogram (Kg) STANDARD_DEVIATION 20.6 • n=5 Participants
Weight customized < 60 Kg	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
Weight customized 60 - 100 Kg	36 participants n=5 Participants	31 participants n=7 Participants	67 participants n=5 Participants
Weight customized > 100 Kg	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Disease activity score C-reactive protein (DAS 28-CRP)	5.1 Units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	5.8 Units on a scale STANDARD_DEVIATION 1.5 • n=7 Participants	5.4 Units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants
Tender joints	23.9 tender joints STANDARD_DEVIATION 18.0 • n=5 Participants	24.3 tender joints STANDARD_DEVIATION 14.2 • n=7 Participants	24.1 tender joints STANDARD_DEVIATION 16.2 • n=5 Participants
Swollen joints	16.2 swollen joints STANDARD_DEVIATION 12.0 • n=5 Participants	18.3 swollen joints STANDARD_DEVIATION 12.2 • n=7 Participants	17.2 swollen joints STANDARD_DEVIATION 12.1 • n=5 Participants
Subject pain assessment per Visual Analogue Scale(VAS)	63.3 millimeters (mm) STANDARD_DEVIATION 19.1 • n=5 Participants	70.5 millimeters (mm) STANDARD_DEVIATION 19.6 • n=7 Participants	66.8 millimeters (mm) STANDARD_DEVIATION 19.6 • n=5 Participants
Subject global assessment per VAS	60.4 mm STANDARD_DEVIATION 18.9 • n=5 Participants	69.9 mm STANDARD_DEVIATION 22.6 • n=7 Participants	65.0 mm STANDARD_DEVIATION 21.2 • n=5 Participants
Physician global assessment per VAS	51.6 mm STANDARD_DEVIATION 16.4 • n=5 Participants	63.9 mm STANDARD_DEVIATION 20.5 • n=7 Participants	57.7 mm STANDARD_DEVIATION 19.5 • n=5 Participants
Health Assessment Questionnaire - Disability Index (HAQ-DI)	1.3 Units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants	1.5 Units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	1.4 Units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
Rheumatoid Factor (RF) Status Unknown	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Rheumatoid Factor (RF) Status Positive	35 participants n=5 Participants	32 participants n=7 Participants	67 participants n=5 Participants
Rheumatoid Factor (RF) Status Negative	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 113

Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.

ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=50 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=45 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose.

Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n = those participants who were evaluated for this measure at each timepoint, for each group respectively.

ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Day 15, (n= 51,47)	0 participants	0 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Day 29, (n= 50,48)	2 participants	0 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Day 43, (n= 50,48)	2 participants	0 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Day 57, (n= 50,47)	1 participants	1 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Day 85, (n= 50,47)	0 participants	0 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Day 113, (n= 50,45)	0 participants	0 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Overall on Treatment visits, (n=51,49)	2 participants	1 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study 28 Days last post dose, (n=2,3)	0 participants	0 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study 56 Days last post dose, (n=2,3)	0 participants	0 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study 85 Days last post dose, (n=4,4)	0 participants	1 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Overall post visits, (n=4,4)	0 participants	1 participants
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study Overall, (n=51,49)	2 participants	2 participants

PRIMARY outcome

Timeframe: Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.

Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n=number of participants who were evaluated for this measure at each timepoint, for each group respectively.

The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Day 15, (n= 51,47)	1 participants	1 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Day 29, (n= 50,48)	1 participants	0 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Day 43, (n= 50,48)	1 participants	0 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Day 57, (n= 50,47)	1 participants	0 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Day 85, (n= 50,47)	1 participants	0 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Day 113, (n=50,45)	1 participants	0 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Overall on Treatment visits, (n=51,49)	1 participants	1 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study 28 Days last post dose, (n=2,3)	0 participants	0 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study 56 Days last post dose, (n=2,3)	0 participants	0 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study 85 Days last post dose, (n=4,4)	0 participants	1 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Overall post visits, (n=4,4)	0 participants	1 participants
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study Overall, (n=51,49)	1 participants	2 participants

PRIMARY outcome

Timeframe: Day 113.

Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive Immunoglobulin G (IMG) samples on Day 113, therefore this analysis was not necessary.

ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 113.

Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive IMG samples on Day 113, therefore this analysis was not necessary.

The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and on day 15, 29, 43, 57, 85 and 113

Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.

ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and day 15, 29, 43, 57, 85 and 113.

Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.

The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Month 4 (Day113).

Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.

DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=48 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=45 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study	-1.67 Units on a scale Interval -2.06 to -1.28	-1.94 Units on a scale Interval -2.46 to -1.42

SECONDARY outcome

Timeframe: Day 113.

Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.

A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=48 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=45 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study	30 participants	30 participants

SECONDARY outcome

Timeframe: Baseline and Month 4 (Day 113).

Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.

HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function 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 indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=46 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study	-0.31 Units on a scale Interval -0.43 to -0.19	-0.58 Units on a scale Interval -0.74 to -0.42

SECONDARY outcome

Timeframe: Baseline and Month 4 (Day113).

Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period. n is the number of participants with baseline and post-baseline values.

HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function 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 indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Dressing and Grooming, (n= 50,46)	-0.44 Units on a scale Interval -0.63 to -0.25	-0.57 Units on a scale Interval -0.79 to -0.34
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Arising, (n= 50,46)	-0.26 Units on a scale Interval -0.44 to -0.08	-0.59 Units on a scale Interval -0.81 to -0.36
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Eating, (n= 50,46)	-0.28 Units on a scale Interval -0.5 to -0.06	-0.57 Units on a scale Interval -0.85 to -0.28
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Walking, (n= 50,46)	-0.26 Units on a scale Interval -0.46 to -0.06	-0.54 Units on a scale Interval -0.75 to -0.34
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Hygiene, (n= 49,46)	-0.33 Units on a scale Interval -0.55 to -0.1	-0.43 Units on a scale Interval -0.65 to -0.22
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Reaching, (n= 49,46)	-0.24 Units on a scale Interval -0.47 to -0.02	-0.50 Units on a scale Interval -0.74 to -0.26
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Gripping, (n= 49,46)	-0.31 Units on a scale Interval -0.54 to -0.07	-0.76 Units on a scale Interval -1.04 to -0.48
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study Activities, (n= 49,46)	-0.39 Units on a scale Interval -0.58 to -0.19	-0.67 Units on a scale Interval -0.9 to -0.45

SECONDARY outcome

Timeframe: Baseline and Day 113.

Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period.

RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=47 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=45 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study Negative at Baseline, negative at Day 113	12 participants	15 participants
Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study Negative at Baseline, positive at Day 113	2 participants	0 participants
Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study Positive at Baseline, negative at Day 113	1 participants	1 participants
Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study Positive at Baseline, positive at Day 113	32 participants	29 participants

SECONDARY outcome

Timeframe: Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.

AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study Deaths	0 participants	0 participants
Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study SAEs	2 participants	3 participants
Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study AEs	37 participants	32 participants
Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study All SAEs Leading to Discontinuation	1 participants	1 participants
Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study All AEs Leading to Discontinuation	3 participants	1 participants

SECONDARY outcome

Timeframe: Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.

Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study Drug-related AEs	14 participants	12 participants
Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study Drug-related SAEs	1 participants	1 participants

SECONDARY outcome

Timeframe: Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With AEs of Special Interest During the ST Study Infections	18 participants	14 participants
Number of Participants With AEs of Special Interest During the ST Study Malignant neoplasm	0 participants	0 participants
Number of Participants With AEs of Special Interest During the ST Study Autoimmune disorders	0 participants	0 participants
Number of Participants With AEs of Special Interest During the ST Study Local injection reactions	3 participants	4 participants
Number of Participants With AEs of Special Interest During the ST Study Systemic injection reactions	4 participants	4 participants

SECONDARY outcome

Timeframe: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes Low Hemoglobin	0 participants	0 participants
Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes Low Hematocrit	0 participants	0 participants
Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes Low Platelet Count	0 participants	0 participants
Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes High Platelet Count	0 participants	0 participants
Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes High Leukocytes	1 participants	2 participants
Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes Low Erythrocytes	0 participants	0 participants

SECONDARY outcome

Timeframe: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept)in the ST period.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) Low Neutrophils + Bands (absolute)	0 participants	0 participants
Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) Low Lymphocytes (absolute)	3 participants	3 participants
Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) High Lymphocytes (absolute)	0 participants	0 participants
Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) High Monocytes (absolute)	0 participants	0 participants
Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) High Basophils (absolute)	0 participants	0 participants
Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) High Eosinophils (absolute)	2 participants	2 participants

SECONDARY outcome

Timeframe: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) High ALT	1 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) High ALP	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) High AST	1 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) High GGT	0 participants	2 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) High Bilirubin (total)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) High BUN	1 participants	1 participants

SECONDARY outcome

Timeframe: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.

MAs= laboratory measurements marked as abnormal: creatinine: >1.5 * pre-Rx; sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN).

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) High Chloride (serum)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) Low Chloride (serum)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) High Calcium (total)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) Low Calcium (total)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) High Protein (total)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) Low Protein (total)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) High Creatinine	0 participants	1 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) High Sodium (serum)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) Low Sodium (serum)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) Low Potassium (serum)	1 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) High Potassium (serum)	0 participants	0 participants

SECONDARY outcome

Timeframe: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or < LLN); glucose (serum): <65 mg/dL or >220 mg/dL.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid High Glucose (Fasting Serum) (n=8; n=21)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid Low Glucose (Fasting Serum) (n=8; n=21)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid Low Albumin (n=51; n=49)	0 participants	1 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid Low Glucose (Serum) (n=51; n=49)	6 participants	1 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid High Glucose(Serum) (n=51; n=49)	2 participants	1 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid High Uric Acid (n=51; n=49)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid High Phosphorous (inorganic) (n=51; n=49)	0 participants	0 participants
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid Low Phosphorous (inorganic) (n=51; n=49)	1 participants	1 participants

SECONDARY outcome

Timeframe: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) High Protein, urine (n= 51,49)	0 participants	2 participants
Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) High Glucose, urine (n= 51,49)	1 participants	0 participants
Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) High Blood, urine (n= 51,49)	1 participants	3 participants
Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) High Leukocyte Esterase, urine (n= 18,17)	2 participants	3 participants
Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) High WBC, urine (n= 15,19)	3 participants	6 participants
Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) High RBC, urine (n= 12,17)	1 participants	7 participants

SECONDARY outcome

Timeframe: Day 113.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.

ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=47 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=44 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study Negative	36 participants	32 participants
Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study Positive	11 participants	12 participants

SECONDARY outcome

Timeframe: Day 113.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.

Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=45 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=45 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study Negative	41 participants	37 participants
Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study Positive	4 participants	8 participants

SECONDARY outcome

Timeframe: At screening and on days 1,15,29,43, 57, 85 and 113.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.

Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Clinically Meaningful Vital Signs During the ST Study	0 participants	0 participants

SECONDARY outcome

Timeframe: Days 1, 15, 29, 43, 57, 85 and 113.

Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period. n=those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Cmin serum abatacept concentration was obtained directly from the concentration-time data.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=51 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort n=49 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study Day 15, (n= 40,41)	13.69 microgram/mL Interval 4.8 to 27.4	11.23 microgram/mL Interval 2.7 to 27.1
Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study Day 29, (n= 49,45)	19.39 microgram/mL Interval 6.1 to 41.8	15.64 microgram/mL Interval 4.4 to 42.2
Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study Day 43, (n= 41,38)	23.40 microgram/mL Interval 10.8 to 44.4	18.06 microgram/mL Interval 5.2 to 48.1
Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study Day 57, (n= 48,38)	24.38 microgram/mL Interval 10.9 to 41.1	21.71 microgram/mL Interval 9.6 to 68.0
Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study Day 85, (n= 47,39)	28.77 microgram/mL Interval 11.3 to 69.2	20.38 microgram/mL Interval 2.6 to 50.0
Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study Day 113, (n=46,37)	28.46 microgram/mL Interval 10.1 to 66.5	23.74 microgram/mL Interval 6.6 to 70.8

SECONDARY outcome

Timeframe: Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had values at each specified timepoint, were evaluated.

The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=90 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Days 197, 281, 365, 449 (n=86, 87, 85, 79)	0 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 533 (n=76)	1 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Days 617, 729, 813 (n=74, 70, 66)	0 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Days 897, 981 (n=66, 58)	0 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1093 (n=65)	2 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1177 (n=8)	0 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1261 (n=57)	1 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1345 (n=24)	0 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1457 (n=59)	3 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1541 (n=24)	1 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1625 (n=18)	2 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Days 1709, 1821 (n=2, 11)	0 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Day 1989 (n=13)	1 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Overall on Treatment (n=88)	11 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study 28 days post last dose (n=18)	0 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study 56 days post last dose (n=15)	2 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study 85 days post last dose (n=16)	2 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study 168 days post last dose (n=3)	2 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Overall post last dose visits (n=23)	4 participants	—
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study Overall (n=90)	13 participants	—

SECONDARY outcome

Timeframe: Baseline, Day 113, Day 1345

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had DAS28-CRP values at Baseline, Day 113 and Day 1345, were evaluated.

DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=88 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study Day 113 (n=88)	-1.89 Units on a scale Interval -2.2 to -1.5	—
Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study Day 1345 (n=61)	-2.39 Units on a scale Interval -2.8 to -1.9	—

SECONDARY outcome

Timeframe: Baseline, Day 113, Day 1345

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had values at Baseline, Day 113 and Day 1345, were evaluated.

A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=88 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study Day 113 (n=88)	59 participants	—
Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study Day 1345 (n=61)	43 participants	—

SECONDARY outcome

Timeframe: Day 113, Day 1345

Population: Participants who received at least 1 dose of abatacept in the LTE study and who had values at Day 113 and Day 1345, were evaluated.

DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=90 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE Remission at Day 113 (n=90)	28 participants	—
Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE Remission at Day 1345 (n=63)	28 participants	—
Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE LDA at Day 113 (n=90)	45 participants	—
Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE LDA at Day 1345 (n=63)	37 participants	—

SECONDARY outcome

Timeframe: Baseline, Day 113, Day 1345

Population: Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.

HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function 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 indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=89 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study HAQ-DI at Day 113 (n=89)	-0.47 units on a scale Interval -0.57 to -0.36	—
Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study HAQ-DI at Day 1345 (n=64)	-0.56 units on a scale Interval -0.71 to -0.42	—

SECONDARY outcome

Timeframe: Baseline, Day 113, Day 1345

Population: Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.

HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=89 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy HAQ DI Response at Day 113 (n=89)	53 participants	—
Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy HAQ DI Response at Day 1345 (n=64)	41 participants	—

SECONDARY outcome

Timeframe: Continuously from start of LTE period up to 7 days post the last dose

Population: Participants who received at least 1 dose of abatacept in the LTE and who had an RF test result up to 7 days post the last dose of abatacept in the LTE study, were evaluated.

RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result).

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=79 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study	20 participants	—

SECONDARY outcome

Timeframe: Baseline, Day 113, Day 1345

Population: Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies and who had values at Baseline, Day 113, and Day 1345, were evaluated.

Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=32 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup DAS-CRP at Day 113 (n=31)	-2.42 units on a scale Standard Error 0.29	—
Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup DAS-CRP at Day 1345 (n=23)	-2.58 units on a scale Standard Error 0.30	—
Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup HAQ-DI at Day 113 (n=32)	-0.60 units on a scale Standard Error 0.10	—
Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup HAQ-DI at Day 1345 (n=25)	-0.65 units on a scale Standard Error 0.12	—

SECONDARY outcome

Timeframe: Day 113, Day 1345

Population: Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies, and who had values at Day 113 and Day 1345, were evaluated.

Remission was defined as DAS 28-CRP < 2.6 and LDA was defined as DAS 28-CRP <= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=32 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup Remission at Day 113 (n=32)	14 participants	—
Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup Remission at Day 1345 (n=24)	9 participants	—
Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup LDA at Day 113 (n=32)	18 participants	—
Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup LDA at Day 1345 (n=24)	13 participants	—

SECONDARY outcome

Timeframe: Continuously from start of LTE Study up to 56 days post the last dose

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE period, were evaluated. Includes all deaths reported during the LTE including those that occurred greater than 56 days after the last dose.

AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=90 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study Deaths	0 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study SAEs	34 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study Related SAEs	6 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study Discontinued due to SAEs	3 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study AEs	86 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study Related AEs	34 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study Discontinued due to AEs	8 participants	—

SECONDARY outcome

Timeframe: Continuously from start of LTE Study up to 56 days post the last dose

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE Study, were evaluated.

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=90 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study Infections	69 participants	—
Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study Autoimmune Disorders	5 participants	—
Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study Malignancies	4 participants	—
Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study Local Injection Site Reactions	2 participants	—
Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study Systemic Injection Reaction	12 participants	—

SECONDARY outcome

Timeframe: Continuously from start of LTE Study up to 56 days post the last dose

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=90 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study Low Hemoglobin (n=90)	1 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study Low Hematocrit (n=90)	0 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study Low Erythrocytes (n=90)	0 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study Low Platelet Count (n=89)	0 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study High Platelet Count (n=89)	0 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study Low Leukocytes (n=90)	2 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study High Leukocytes (n=90)	5 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study Low Neutrophils + bands	0 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study Low Lymphocytes (n=90)	6 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study High Lymphocytes (n=90)	1 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study High Monocytes (n=90)	2 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study High Basophils (n=90)	0 participants	—
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study High Eosinophils (n=90)	13 participants	—

SECONDARY outcome

Timeframe: Continuously from start of LTE Study up to 56 days post the last dose

Population: Participants who received at least 1 dose of abatacept in the LTE Study and with specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx; creatinine: >1.5 * pre-Rx.

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=90 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study High ALP (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study High AST (n=90)	1 participants	—
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study High ALT (n=90)	3 participants	—
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study High G-GT (n=90)	2 participants	—
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study High Bilirubin (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study High BUN (n=90)	6 participants	—
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study High Creatinine (n=90)	7 participants	—

SECONDARY outcome

Timeframe: Continuously from start of LTE Study up to 56 days post the last dose

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE study, were summarized. n=number of participants evaluated.

Sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or <LLN); glucose (serum): <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx).

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=90 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High and/or Low Sodium (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study Low Potassium (n=90)	2 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High Potassium (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High and/or Low Chloride	0 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High and/or Low Total Calcium (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High and/or Low Inorganic Phosphorus (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study Low Glucose (n=90)	21 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High Glucose (n=90)	1 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study Low Fasting Glucose (n=28)	3 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High Fasting Glucose (n=28)	1 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High and/or Low Total Protein (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study Low Albumin (n=90)	0 participants	—
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study High Uric Acid (n=90)	1 participants	—

SECONDARY outcome

Timeframe: Continuously from start of LTE Study up to 56 days post the last dose

Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE period, were evaluated. n=number of participants evaluated.

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).

Outcome measures

Measure	Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort n=89 Participants In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study High Urine Protein (n=89)	6 participants	—
Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study High Urine Glucose (n=89)	2 participants	—
Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study High Urine Blood (n=89)	13 participants	—
Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study High Urine Esterase (n=45)	12 participants	—
Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study High Urine WBC (n=51)	26 participants	—
Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study High Urine RBC (n=47)	16 participants	—

Adverse Events

Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Short Term Study: SC Abatacept Monotherapy

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Long Term Extension (LTE):125 mg SC Abatacept

Serious events: 34 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate n=51 participants at risk In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	Short Term Study: SC Abatacept Monotherapy n=49 participants at risk In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.	Long Term Extension (LTE):125 mg SC Abatacept n=90 participants at risk During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Nervous system disorders Carotid artery stenosis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
General disorders Chest pain	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.2% 2/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Pneumonia	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.0% 1/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Reproductive system and breast disorders Rectocele	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Renal and urinary disorders Renal colic	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Cardiac disorders Angina pectoris	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Bronchopneumonia	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Renal and urinary disorders Calculus ureteric	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Renal and urinary disorders Calculus urinary	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Cardiac disorders Myocardial ischaemia	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Hepatobiliary disorders Cholelithiasis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.2% 2/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Reproductive system and breast disorders Cystocele	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Nervous system disorders Nerve compression	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Diverticulitis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	3.3% 3/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Vascular disorders Peripheral vascular disorder	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Pneumonia haemophilus	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Vascular disorders Deep vein thrombosis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Renal and urinary disorders Renal failure acute	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Nervous system disorders Gliosis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Metabolism and nutrition disorders Obesity	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Pelvic inflammatory disease	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.2% 2/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Vascular disorders Aortic stenosis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Gastroenteritis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Cardiac disorders Atrial fibrillation	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.2% 2/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Nervous system disorders Cerebrovascular accident	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Cardiac disorders Myocardial infarction	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	1.1% 1/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.0% 1/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Pneumocystis Jiroveci Pneumonia	2.0% 1/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Injury, poisoning and procedural complications Cartilage Injury	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.0% 1/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Nervous system disorders Syncope	2.0% 1/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.

Other adverse events

Measure	Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate n=51 participants at risk In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.	Short Term Study: SC Abatacept Monotherapy n=49 participants at risk In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.	Long Term Extension (LTE):125 mg SC Abatacept n=90 participants at risk During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
Infections and infestations Pneumonia	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	5.6% 5/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Skin and subcutaneous tissue disorders Rash	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.7% 6/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
General disorders Fatigue	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	5.6% 5/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Psychiatric disorders Insomnia	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.7% 6/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Sinusitis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	24.4% 22/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	7.8% 7/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Psychiatric disorders Depression	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	5.6% 5/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Injury, poisoning and procedural complications Contusion	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	8.9% 8/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Vascular disorders Hypertension	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	8.9% 8/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.7% 6/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Gastrointestinal disorders Nausea	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	5.6% 5/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Upper respiratory tract infection	11.8% 6/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	4.1% 2/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	23.3% 21/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Cellulitis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	5.6% 5/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Bronchitis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	13.3% 12/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Nervous system disorders Headache	9.8% 5/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.1% 3/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	5.6% 5/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Influenza	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	7.8% 7/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Nasopharyngitis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	13.3% 12/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Gastroenteritis	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	5.6% 5/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Tooth abscess	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	7.8% 7/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Gastrointestinal disorders Diarrhoea	5.9% 3/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.0% 1/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.7% 6/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Injury, poisoning and procedural complications Fall	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	8.9% 8/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Herpes zoster	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	7.8% 7/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Infections and infestations Urinary tract infection	2.0% 1/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.1% 3/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	18.9% 17/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Gastrointestinal disorders Vomiting	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	8.2% 4/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
General disorders Injection site pruritus	5.9% 3/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	2.0% 1/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
General disorders Pyrexia	2.0% 1/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.1% 3/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/51 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	6.1% 3/49 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.	0.00% 0/90 • Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014. ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

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