Phase IIIB Switching From Intravenous to Subcutaneous Study | NCT00663702

Obsolete or Duplicate NCT IDs

Not provided

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Abatacept

Name	Type	Description	Arm Group Labels	Other Names
Abatacept	Drug	Subcutaneous injection, 125 mg/mL, once weekly, 48 months	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85	An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.	Day 1 (Baseline) through Day 85
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation	An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.	Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality	LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75preRx. Erythrocytes (10^6 c/uL) <0.75preRx. Platelet count (10^9 c/L) <0.67LLN or 1.5ULN or, if preRx<LLN, use <0.5preRx and <100,000 mm^3. Leukocytes (10^3 c/uL) <0.75LLN or >1.25ULN or, if preRx<LLN, use <0.8preRx or >ULN or, if preRx>ULN, use >1.2preRx or <LLN. Eosinophils >0.75010^3 c/uL. Lymphocytes <0.75010^3 c/uL or >7.50*10^3 c/uL.	Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality	LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2ULN or if preRx>ULN, use 3preRx. Alanine aminotransferase (U/L)>3ULN or if preRx>ULN, use >4preRx. G-glutamyl transferase (U/L)>2ULN or if preRx>ULN, use >3preRx. Blood urea nitrogen (mg/dL)>2preRx. Creatinine (mg/dL)>1.5preRx.

Secondary Outcomes

Measure	Description	Time Frame
Mean Trough Serum Concentration (Cmin) of Abatacept	Cmin of abatacept was determined from serum samples.	Days 29, 85, 57, and 85
Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recruitment from 2 Bristol-Myers Squibb (BMS) studies (BMS IM101-029 [NCT00048581] and BMS IM101-102 [NCT00048568]).
Completion of final quarterly dosing visit in NCT00048581 or NCT00048568 as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.
Agreement to participate in BMS IM101-185 (NCT00663702) on final quarterly dosing visit in NCT00048581 or NCT00048568 study as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.
At the time of completion of the NCT00048581 or NCT00048568 protocol, participant did not meet any criteria requiring their discontinuation.
Drug stabilization requirements: Participants who received concomitant medications (disease-modifying antirheumatic drugs, corticosteroids, and nonsteroidal anti-inflammatory drugs) at the time of their last quarterly dosing visit for NCT00048581 or NCT00048568 were required to maintain stable dose levels from the time they signed consent until the end of the first 3 months (Day 85) of the current study.
Willingness to self-inject study medication (abatacept) or allow a caregiver to inject study medication.
Willingness to adhere to study visit schedule and comply with other protocol requirements.
Male or female (not nursing or pregnant)genders, at least 18 years of age. Women of childbearing potential (WOCBP) must have been practicing adequate contraceptive measures during the study and for up to 10 weeks after the last infusion of study medication in such a manner that the risk of pregnancy was minimized. WOCBP must have had a negative serum or urine pregnancy test result (minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 48 hours prior to the start of study medication.

Exclusion Criteria:

The following treatment or therapies should not be started on or after the final quarterly dosing visit from the NCT00048581 or NCT00048568 study: Any biologic; immunoabsorption columns (such as Prosorba columns); mycophenolate mofetil; cyclosporin A or other calcineurin inhibitors; D-penicillamine; any live vaccines within 3 months of Day 1 or scheduled to receive a live vaccine during the course of the study
Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, or a concomitant medical condition that, in the opinion of the Investigator, might have placed the participation at unacceptable risk for study participation
Any clinical laboratory test result that was considered to be abnormal or not within acceptable limits on the final quarterly dosing visit of NCT00048581 or NCT00048568. Screening laboratory test results for NCT00663702 were based on the Day 1821 visit of NCT00048581 or NCT00048568 for participants enrolled at sites in the US or Canada and on the Day 1989 visit of NCT00048568 for participants enrolled at sites in Mexico.
Imprisonment or involuntarily incarceration for treatment of either a psychiatric or physical (eg, infectious disease) illness
Impairment, incapacitation, inability to complete study-related assessments, or illiteracy.

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology Associates Of N. Al, P.C.		Huntsville	Alabama	35801	United States
Allergy & Rheumatology Medical Clinic, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27229685	Derived	Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
BG001	Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00056.5± 10.2 BG00152.8± 13.8 BG00254.3± 12.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00042 BG00159 BG002

Race/Ethnicity, Customized

Number

Partcipants

Title

Denominators

Categories

White

Title	Measurements
	BG00047 BG00170 BG002

Region of Enrollment

Number

Participants

Title

Denominators

Categories

North America

Title	Measurements
	BG00052 BG00116 BG002

Mean Baseline High Sensitivity C-Reactive Protein Level

Mean

Standard Deviation

μg/mL

Title

Denominators

Categories

Title	Measurements
	BG0000.94± 0.65 BG0010.92± 0.88 BG002

Mean Baseline 28 Joint Disease Activity Score (DAS 28)

The DAS 28 is a 28-item joint disease activity score used to quantify disease expression and progression in rheumatoid arthritis. Severity is indicated with increasing item score on the scale with 0=no joints affected and 28=all joints affected.

Mean

Standard Deviation

Score on a scale

Title

Denominators

Categories

Title	Measurements
	BG0003.55± 1.20 BG001

Mean Number of Tender Joints at Baseline

Mean

Standard Deviation

Joints

Title

Denominators

Categories

Title	Measurements
	BG0009.1± 12.8 BG0018.8± 12.4 BG002

Mean Number of Swollen Joints at Baseline

Mean

Standard Deviation

Joints

Title

Denominators

Categories

Title	Measurements
	BG0005.4± 6.4 BG0014.3± 5.9 BG002

Participant Weight at Baseline

Number

Participants

Title

Denominators

Categories

Less than 60 kilograms

Title	Measurements
	BG0009 BG00114 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85

An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.

All participants who received at least 1 dose of study medication

Posted

Number

Participants

Day 1 (Baseline) through Day 85

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000123

Title

Denominators

Categories

Deaths

Title	Measurements
	OG0000

SAEs

Title	Measurements
	OG0001

Treatment-related SAEs

Secondary

Mean Trough Serum Concentration (Cmin) of Abatacept

Cmin of abatacept was determined from serum samples.

All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Days 29, 85, 57, and 85

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Primary

Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation

An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.

All participants who received at least 1 dose of study medication

Posted

Number

Participants

Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Primary

Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality

LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Number

Participants

Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts

Primary

Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality

LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Number

Participants

Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants

Primary

Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality

LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, \

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Number

Participants

Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants

Primary

Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality

LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Number

Participants

Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85

Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.

All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable

Posted

Number

Percentage of participants

Day 1 (Baseline) through Day 85

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants

Secondary

Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85

Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers >10) included:

A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline
A negative baseline immunogenicity response and a positive immunogenicity response postbaseline
A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value

Posted

Number

Percentage of participants

Day 1 (Baseline) through Day 85

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Secondary

Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time

The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)

All participants who received at least 1 dose of study medication

Posted

Mean

Standard Deviation

Units on a scale

Day 1 (Baseline) through Day 1093

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
OG001	Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)

Secondary

Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:

LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP <2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)

All participants who received at least 1 dose of study medication

Posted

Number

95% Confidence Interval

Percentage of participants

Day 1 (Baseline) through Day 1093

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
OG001

Secondary

Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time

The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.

All participants who received at least 1 dose of study medication

Posted

Mean

Standard Deviation

Units on a scale

Day 1 (Baseline) to Day 1093

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
OG001	Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Primary

Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality

preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Number

Participants

Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Primary

Number of Participants With Adverse Events of Special Interest

AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).

All participants who received at least 1 dose of study medication.

Posted

Number

Participants

Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Primary

Mean Sitting Systolic and Diastolic Blood Pressure (BP)

BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Mean

Standard Deviation

mm Hg

Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Primary

Mean Heart Rate

Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Mean

Standard Deviation

Beats per minute

Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Primary

Mean Temperature

Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.

All participants who received at least 1 dose of study medication. n=patients evaluable

Posted

Mean

Standard Deviation

Degrees Celsius

Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821

ID	Title	Description
OG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Subcutaneous Abatacept, 125 mg	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.			43	123	101	123

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Diverticulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Pericardial effusion	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Aphasia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Renal colic	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected123 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Appendicitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected123 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Dengue fever	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected123 at risk
Soft tissue infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected123 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Sarcoidosis	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Urosepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Angina unstable	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Cholecystitis infective	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected123 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Device failure	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Bundle branch block left	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected123 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected123 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected123 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected123 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected123 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0009 affected123 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected123 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00014 affected123 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected123 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00034 affected123 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected123 at risk
Oedema peripheral	General disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected123 at risk
Depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected123 at risk
Pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0007 affected123 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00013 affected123 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00017 affected123 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected123 at risk
Influenza like illness	General disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected123 at risk
Sinusitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00010 affected123 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00024 affected123 at risk
Conjunctivitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0009 affected123 at risk
Dizziness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected123 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0009 affected123 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected123 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00030 affected123 at risk

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000069594	Abatacept

Title	Measurements
	OG0000

Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

ID	Term
D018796	Immunoconjugates
D000906	Antibodies
D007136	Immunoglobulins
D012712	Serum Globulins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D005916	Globulins