Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese participants with active rheumatoid arthritis and inadequate response to methotrexate.
Interventions
IV vial, 125-mg infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141.
Solution in prefilled syringes, SC, 125 mg, once weekly, for 169 days and then for 52 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Meeting criteria of the American Rheumatism Association for the diagnosis of rheumatoid arthritis (RA) and the American College of Rheumatology functional Classes I, II, or III. * Inadequate response (as deemed by investigator) to methotrexate taken for at least 3 months (12 weeks) at a stable dose (6 to 8 mg/week) for 28 days prior to randomization (Day 1). * Stabilization requirements for concomitant therapy: Oral corticosteroid treatment reduced to the equivalent of ≤10 mg prednisolone daily for 28 days and stabilized for at least 25 of 28 days prior to treatment (Day 1). No intra-articular, intravenous, or intramuscular injections of corticosteroids were permitted within 28 days prior to randomization (Day 1.) * Washout requirements: Participants receiving combination RA therapy had to discontinue the following therapies at least 28 days prior to treatment (Day 1): disease-modifying antirheumatic drugs (DMARDs), such as gold (auranofin and aurothiomalate sodium), actarit, bucillamine, azathioprine, salazosulfapyridine, lobenzarit disodium, D-penicillamine, cyclophosphamide, mycophenolate mofetil, mizoribine; cyclosporin, tacrolimus, and other calcineurin inhibitors; and immunoadsorption columns. * Disease Activity Requirements: At randomization (Day 1), participants had to meet the following disease activity criteria: Swollen joint count: 10 or more swollen joints (66 joint count); tender joint count: 12 or more tender joints (68 joint count); C reactive protein (CRP): ≥0.8 mg/dL (result from screening visit). * For participants receiving methotrexate plus other DMARDs(washout of a combination therapy required): At screening visit, participants had to meet the following disease activity criteria: Swollen joint count: 6 or more swollen joints (66 joint count); tender joint count: 8 or more tender joints (68 joint count); CRP: no restriction on CRP (not applicable). * After washout, at randomization (Day 1), participants must meet the following disease activity criteria: Swollen joint count-10 or more swollen joints (66 joint count) and tender joint count-12 or more tender joints (68 joint count) and CRP: ≥0.8 mg/dL (result from screening visit). For those whose screening period were longer than 4 weeks, CRP test needed to be performed on Day * 28 to Day -3 (prior to treatment Day 1) to verify eligibility. Key
Exclusion criteria
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease. Concomitant medical conditions that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this study. * Female participants who had undergone breast cancer screening that was suspicious for malignancy, and in whom the possibility of malignancy could not be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. * History of cancer within the last 5 years (other than nonmelanoma skin cell cancers cured by local resection) * Existing nonmelanoma skin cell cancers had been removed prior to the first administration. Participants with carcinoma in situ, treated with definitive surgical intervention prior to study entry were allowed to participate. * Clinically significant drug or alcohol abuse * Any serious acute bacterial infection (such as pneumonia or pyelonephritis unless treated and completely resolved with antibiotics) * Serious, chronic, or recurrent bacterial infections (such as recurrent pneumonia, chronic bronchiectasis) * Those at risk for tuberculosis (TB). Specifically, those with current clinical, radiographic, or laboratory evidence suggestive of active TB; history of active TB within the last 3 years, even if treated; history of active TB more than 3 years ago unless there was documentation that the prior anti-TB treatment was appropriate in type and duration; latent TB that was not successfully treated. Participants with a positive result on TB screening test indicative of latent TB were not eligible for the study unless active TB infection had been ruled out and treatment for latent TB with isoniazid had been initiated for at least 4 weeks prior to administration of the study drug and the participant had a negative finding for TB on a chest X-ray film at enrollment. * Herpes zoster resolving less than 2 months prior to enrollment * Current evidence (as assessed by the investigator) suggestive of active or latent bacterial or viral infections, including human immunodeficiency virus infection. * Physical examination and laboratory test findings: Hepatitis B surface antigen-positive status; hepatitis C antibody-positive status. Any of the following laboratory values: Hemoglobin concentration: \<.5 g/dL; white blood cell count: \<3,000/μL (3\*10\^9/L); platelet count: \<100,000/mm\^3(100\*10\^9/L); serum creatinine: \>2 times upper limit of normal (ULN); serum alanine aminotransferase: \>2 ULN; serum aspartate aminotransferase: \>2 ULN. * Prohibited treatments and/or therapies: Prior exposure to abatacept (CTLA4-Ig); prior RA treatment with any biologics, such as anti-tumor necrosis factor therapy; prior exposure to any investigational biologic not currently approved in Japan; exposure to any study medication in any other previous study within 4 weeks or 5 half-lives, whichever was longer; receipt of any live vaccines within 3 months of administration of study medication or scheduled to receive live vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period | Day 169 | The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have \>=20% fewer tender joints and \>=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug. |
| Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period | Day 533 | The ACR score indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score= a percentage. To qualify for a score of 20, 50 or 70 (ACR20, ACR50 or ACR70), the patient must have \>=20%, \>=50% or \>=70%, respectively, fewer tender joints and \>=20%, \>=50% or \>=70%, respectively, fewer swollen joints and show 20%, 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Treatment groups represent treatment received in the short term period. Percentage calculated as n/m with n=number of paticipants with sustained ACR response at Day 533; m= long term participants who received at least one dose of drug and were ACR responders in the short term period. |
| Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period | Baseline to Day 533 | Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value. |
| Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period | Day 533 | The Health Assessment Questionnaire (HAQ) disability index assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The higher the number the worse the outcome. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. HAQ response=reduction of at least 0.30 units in HAQ score from baseline. The percentage of participants with a reduction of at least 0.30 units in their HAQ score from baseline is presented. Baseline is Day 1 of the study or last non-missing pre-treatment value. Treatment groups represent treatment received in the short term period. |
| Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period | Baseline to Day 533 | The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS \>5.1 implies active disease; \<3.2, well controlled disease; and \<2.6, remission.). Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period | Day 533 | EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP\<2.6. |
| Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Baseline to Day 169 | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication. |
| Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Baseline to Day 533 and up to 56 days following last dose in Long-Term period | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication. |
| Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Baseline to Day 169 | lower limit of normal(LLN); upper limit of normal(ULN); pretreatment(preRX). Hemoglobin (g/dL): \>3 g/dL decrease from preRX; hematocrit (%): \<0.75\*preRX; erythrocytes (\*10\^6 c/uL): \<0.75\*preRX; platelet count (\*10\^9 c/uL): \<0.67\*LLN or \>1.5\*ULN, of if preRX\<LLN, use 0.5\*preRX and \<100,000/mm\^3; leukocytes (\*10\^3 c/uL): \<0.75\*LLN or \>1.25\*ULN, or if preRX \<LLN, use \<0.8\*preRX or \>ULN, or if preRX\>ULN, use \>1.2\*preRX or \<LLN; neutrophils+bands (\*10\^3 c/uL): if value \<1.0\*10\^3 c/uL; eosinophils (\*10\^3 c/uL): if value \>0.750\*10\^3 c/uL; basophils (\*10\^3 c/uL): if value \>400/mm\^3; monocytes (\*10\^3 c/uL): if value \>2000/mm\^3; lymphocytes (\*10\^3 c/uL): if value \<0.750\*10\^3 c/uL or if value \>7.50\*10\^3 c/uL. |
| Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period | Day 169 | The American College of Rheumatology (ACR) scores of 50 and 70 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score represents a percentage. To qualify for an ACR50 or ACR70 scores, the patient must have \>=50% or \>=70%, respectively, fewer tender joints and \>=50% or \>=70%, respectively, fewer swollen joints and show 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). |
| Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Baseline to Day 169 | ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. alkaline phosphatase (ALP) (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; aspartate aminotransferase (AST) (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; alanine aminotransferase(ALT) (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; Gamma glutamyltransferase(GGT) (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; bilirubin (mg/dL): \>2\*ULN, or if preRX\>ULN, use \>4\*preRX; blood urea nitrogen (mg/dL): \>2\*preRX; creatinine (mg/dL): \>1.5\*preRX. |
| Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Baseline to Day 169 | LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): \<0.95\*LLN or \>1.05\*ULN, or if preRX\<LLN, use \<0.95\*preRX or \>ULN, or if preRX\>ULN, use 1.05\*preRX or \<LLN; potassium (mEq/L): \<0.9\*LLN or \>1.1\*ULN, or if preRX\<LLN, use \<0.9\*preRX or \>ULN, or if preRX\>ULN, use 1.1\*preRX or \<LLN; chloride (mEq/L): \<0.75\*LLN or \>1.125\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; calcium (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; phosphorus (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.67\*preRX or \>ULN, or if preRX\>ULN, use 1.33\*preRX or \<LLN. |
| Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Baseline to Day 533 | ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. ALP (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; AST (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; ALT (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; GGT (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; bilirubin (mg/dL): \>2\*ULN, or if preRX\>ULN, use \>4\*preRX; blood urea nitrogen (mg/dL): \>2\*preRX; creatinine (mg/dL): \>1.5\*preRX. |
| Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Baseline to Day 533 | LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): \<0.95\*LLN or \>1.05\*ULN, or if preRX\<LLN, use \<0.95\*preRX or \>ULN, or if preRX\>ULN, use 1.05\*preRX or \<LLN; potassium (mEq/L): \<0.9\*LLN or \>1.1\*ULN, or if preRX\<LLN, use \<0.9\*preRX or \>ULN, or if preRX\>ULN, use 1.1\*preRX or \<LLN; chloride (mEq/L): \<0.75\*LLN or \>1.125\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; calcium (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; phosphorus (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.67\*preRX or \>ULN, or if preRX\>ULN, use 1.33\*preRX or \<LLN. |
| Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Baseline to Day 533 | LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): \>3 g/dL decrease from preRX; hematocrit (%): \<0.75\*preRX; erythrocytes (\*10\^6 c/uL): \<0.75\*preRX; platelet count (\*10\^9 c/uL): \<0.67\*LLN or \>1.5\*ULN, of if preRX\<LLN, use 0.5\*preRX and \<100,000/mm\^3; leukocytes (\*10\^3 c/uL): \<0.75\*LLN or \>1.25\*ULN, or if preRX \<LLN, use \<0.8\*preRX or \>ULN, or if preRX\>ULN, use \>1.2\*preRX or \<LLN; neutrophils+bands (\*10\^3 c/uL): if value \<1.0\*10\^3 c/uL; eosinophils (\*10\^3 c/uL): if value \>0.750\*10\^3 c/uL; basophils (\*10\^3 c/uL): if value \>400/mm\^3; monocytes (\*10\^3 c/uL): if value \>2000/mm\^3; lymphocytes (\*10\^3 c/uL): if value \<0.750\*10\^3 c/uL or if value \>7.50\*10\^3 c/uL. |
| Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period | Baseline to Day 169 | Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. |
| Percentage of Participants With HAQ Response at Day 169 in the Short Term Period | Day 169 | The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. The HAQ-DI response is defined as a reduction of at least 0.30 units in HAQ score from baseline. |
| Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants | Baseline to 6 Months | The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS \>5.1 implies active disease; \<3.2, well controlled disease; and \<2.6, remission.). Baseline is Day 1 or last non-missing pre-treatment value. |
| Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period | Day 169 | EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (\<) 2.6. |
Countries
Japan
Participant flow
Recruitment details
Study started 8 December 2009; short-term period ended 25 February 2011; long-term period ended 26 October 2012.
Pre-assignment details
171 participants were enrolled, 118 participants were randomized and treated in the short-term period.
Participants by arm
| Arm | Count |
|---|---|
| Subcutaneous (SC) Abatacept, 125 mg Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug. | 59 |
| Intravenous (IV) Abatacept, 125 mg Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug. | 59 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Period | Follow-up no longer required /protocol | 15 | 20 |
| Follow-up Period | Other | 2 | 1 |
| Follow-up Period | Withdrawal by Subject | 1 | 0 |
| Long-term Period | Adverse Event | 2 | 1 |
| Long-term Period | Lack of Efficacy | 0 | 2 |
| Long-term Period | Other | 1 | 2 |
| Long-term Period | Withdrawal by Subject | 1 | 0 |
| Short-term Period | Adverse Event | 2 | 3 |
Baseline characteristics
| Characteristic | Subcutaneous (SC) Abatacept, 125 mg | Intravenous (IV) Abatacept, 125 mg | Total |
|---|---|---|---|
| Age, Continuous | 56.1 Years STANDARD_DEVIATION 12.3 | 55.2 Years STANDARD_DEVIATION 13.6 | 55.6 Years STANDARD_DEVIATION 12.9 |
| DAS28-CRP | 5.62 Units on a scale STANDARD_DEVIATION 0.84 | 5.95 Units on a scale STANDARD_DEVIATION 0.91 | 5.79 Units on a scale STANDARD_DEVIATION 0.89 |
| Duration of Disease | 7.5 Years STANDARD_DEVIATION 9.2 | 5.3 Years STANDARD_DEVIATION 7.3 | 6.4 Years STANDARD_DEVIATION 8.3 |
| Duration of Disease Category >10 years | 17 Participants 28.8 | 12 Participants 20.3 | 29 Participants 24.6 |
| Duration of Disease Category >2 to <= 5 years | 7 Participants 11.9 | 11 Participants 18.6 | 18 Participants 15.3 |
| Duration of Disease Category <= 2 years | 25 Participants 42.4 | 30 Participants 50.8 | 55 Participants 46.6 |
| Duration of Disease Category >5 to <= 10 years | 10 Participants 16.9 | 6 Participants 10.2 | 16 Participants 13.6 |
| HAQ Score | 1.28 Units on a scale STANDARD_DEVIATION 0.69 | 1.32 Units on a scale STANDARD_DEVIATION 0.64 | 1.30 Units on a scale STANDARD_DEVIATION 0.66 |
| Methotrexate dose | 7.3 mg/week STANDARD_DEVIATION 1 | 7.3 mg/week STANDARD_DEVIATION 1 | 7.3 mg/week STANDARD_DEVIATION 0.9 |
| Race/Ethnicity, Customized Asian (not Japanese) | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Japanese | 58 Participants | 59 Participants | 117 Participants |
| Sex: Female, Male Female | 38 Participants | 48 Participants | 86 Participants |
| Sex: Female, Male Male | 21 Participants | 11 Participants | 32 Participants |
| Swollen Joint Count | 16.4 Number of joints STANDARD_DEVIATION 7 | 17.6 Number of joints STANDARD_DEVIATION 7.2 | 17.0 Number of joints STANDARD_DEVIATION 7.1 |
| Tender Joint Count | 20.9 Number of joints STANDARD_DEVIATION 9.3 | 22.3 Number of joints STANDARD_DEVIATION 9.9 | 21.6 Number of joints STANDARD_DEVIATION 9.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 68 / 112 | 35 / 59 | 25 / 59 |
| serious Total, serious adverse events | 10 / 112 | 3 / 59 | 4 / 59 |
Outcome results
Primary
Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period
Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.
Time frame: Baseline to Day 533
Population: Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period | -0.71 units on a scale |
| Intravenous (IV) Abatacept, 125 mg | Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period | -0.71 units on a scale |
Primary
Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period
The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS \>5.1 implies active disease; \<3.2, well controlled disease; and \<2.6, remission.). Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.
Time frame: Baseline to Day 533
Population: Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period | -3.27 units on a scale |
| Intravenous (IV) Abatacept, 125 mg | Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period | -3.49 units on a scale |
Primary
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period
The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have \>=20% fewer tender joints and \>=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug.
Time frame: Day 169
Population: N= All randomized participants who received at least 1 dose of study medication and were analyzed. n=number of participants with ACR20 response at Day 169: 54, 49, respectively. n/N= percentage: 54/59; 49/59.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period | 91.5 Percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period | 83.1 Percentage of participants |
Primary
Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period
The Health Assessment Questionnaire (HAQ) disability index assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The higher the number the worse the outcome. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. HAQ response=reduction of at least 0.30 units in HAQ score from baseline. The percentage of participants with a reduction of at least 0.30 units in their HAQ score from baseline is presented. Baseline is Day 1 of the study or last non-missing pre-treatment value. Treatment groups represent treatment received in the short term period.
Time frame: Day 533
Population: N=number of participants treated with at least 1 dose of study drug and with HAQ data available. n=number of participants with HAQ response. n/N = 41/52 and 31/51 in SC and IV arms, respectively. Treatment groups represent treatment received in the short term period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period | 78.8 percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period | 60.8 percentage of participants |
Primary
Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period
The ACR score indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score= a percentage. To qualify for a score of 20, 50 or 70 (ACR20, ACR50 or ACR70), the patient must have \>=20%, \>=50% or \>=70%, respectively, fewer tender joints and \>=20%, \>=50% or \>=70%, respectively, fewer swollen joints and show 20%, 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Treatment groups represent treatment received in the short term period. Percentage calculated as n/m with n=number of paticipants with sustained ACR response at Day 533; m= long term participants who received at least one dose of drug and were ACR responders in the short term period.
Time frame: Day 533
Population: m=Long term period participants who received at least one dose of drug and were ACR responders in short term period: ACR20= 49, 46; ACR50= 35, 34; ACR70= 20, 16. n=number of paticipants with sustained ACR response at Day 533. n/m = percentage
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period | ACR 20 (n/m= 47/49; 45/46) | 95.9 percentage of participants |
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period | ACR 50 (n/m= 30/35; 32/34) | 85.7 percentage of participants |
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period | ACR 70 (n/m= 15/20; 15/16) | 75.0 percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period | ACR 20 (n/m= 47/49; 45/46) | 97.8 percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period | ACR 50 (n/m= 30/35; 32/34) | 94.1 percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period | ACR 70 (n/m= 15/20; 15/16) | 93.8 percentage of participants |
Secondary
Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.
Time frame: Baseline to Day 533 and up to 56 days following last dose in Long-Term period
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuation due to AEs | 2 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Deaths | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | SAEs | 5 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related SAEs | 4 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuation due to SAEs | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | AEs | 49 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related AEs | 31 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuation due to AEs | 1 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuation due to SAEs | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Deaths | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related AEs | 32 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | SAEs | 5 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | AEs | 49 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related SAEs | 3 Participants |
Secondary
Long-term Period: 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 (mEq/L): \<0.95\*LLN or \>1.05\*ULN, or if preRX\<LLN, use \<0.95\*preRX or \>ULN, or if preRX\>ULN, use 1.05\*preRX or \<LLN; potassium (mEq/L): \<0.9\*LLN or \>1.1\*ULN, or if preRX\<LLN, use \<0.9\*preRX or \>ULN, or if preRX\>ULN, use 1.1\*preRX or \<LLN; chloride (mEq/L): \<0.75\*LLN or \>1.125\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; calcium (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; phosphorus (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.67\*preRX or \>ULN, or if preRX\>ULN, use 1.33\*preRX or \<LLN.
Time frame: Baseline to Day 533
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, low | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, high | 1 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, low | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, low | 0 Participants |
Secondary
Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): \>3 g/dL decrease from preRX; hematocrit (%): \<0.75\*preRX; erythrocytes (\*10\^6 c/uL): \<0.75\*preRX; platelet count (\*10\^9 c/uL): \<0.67\*LLN or \>1.5\*ULN, of if preRX\<LLN, use 0.5\*preRX and \<100,000/mm\^3; leukocytes (\*10\^3 c/uL): \<0.75\*LLN or \>1.25\*ULN, or if preRX \<LLN, use \<0.8\*preRX or \>ULN, or if preRX\>ULN, use \>1.2\*preRX or \<LLN; neutrophils+bands (\*10\^3 c/uL): if value \<1.0\*10\^3 c/uL; eosinophils (\*10\^3 c/uL): if value \>0.750\*10\^3 c/uL; basophils (\*10\^3 c/uL): if value \>400/mm\^3; monocytes (\*10\^3 c/uL): if value \>2000/mm\^3; lymphocytes (\*10\^3 c/uL): if value \<0.750\*10\^3 c/uL or if value \>7.50\*10\^3 c/uL.
Time frame: Baseline to Day 533
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hemoglobin, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hemoglobin, high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hematocrit, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hematocrit, high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Erythrocytes, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Erythrocytes, high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Platelet count, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Platelet count, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Leukocytes, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Leukocytes, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Neutrophils + bands (absolute), low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Neutrophils + bands (absolute), high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Eosinophils (absolute), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Eosinophils (absolute), high | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Basophils (absolute), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Basophils (absolute), high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Monocytes (absolute), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Monocytes (absolute), high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Lymphocytes (absolute), low | 11 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Lymphocytes (absolute), high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Monocytes (absolute), high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hemoglobin, low | 1 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Neutrophils + bands (absolute), low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hemoglobin, high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Basophils (absolute), high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hematocrit, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Neutrophils + bands (absolute), high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Hematocrit, high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Lymphocytes (absolute), high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Erythrocytes, low | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Eosinophils (absolute), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Erythrocytes, high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Monocytes (absolute), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Platelet count, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Eosinophils (absolute), high | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Platelet count, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Lymphocytes (absolute), low | 8 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Leukocytes, low | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Basophils (absolute), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria | Leukocytes, high | 1 Participants |
Secondary
Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. ALP (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; AST (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; ALT (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; GGT (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; bilirubin (mg/dL): \>2\*ULN, or if preRX\>ULN, use \>4\*preRX; blood urea nitrogen (mg/dL): \>2\*preRX; creatinine (mg/dL): \>1.5\*preRX.
Time frame: Baseline to Day 533
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alkaline phosphatase (ALP), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALP, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Aspartate aminotransferase (AST), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | AST, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alanine aminotransferase (ALT), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALT, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | G-glutamyl transferase (GGT), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | GGT, high | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, high | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alkaline phosphatase (ALP), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | GGT, high | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALP, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Aspartate aminotransferase (AST), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | AST, high | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, high | 1 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alanine aminotransferase (ALT), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALT, high | 1 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, high | 4 Participants |
| Intravenous (IV) Abatacept, 125 mg | Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | G-glutamyl transferase (GGT), low | NA Participants |
Secondary
Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants
The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS \>5.1 implies active disease; \<3.2, well controlled disease; and \<2.6, remission.). Baseline is Day 1 or last non-missing pre-treatment value.
Time frame: Baseline to 6 Months
Population: All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants | -2.97 Units on a scale |
| Intravenous (IV) Abatacept, 125 mg | Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants | -2.75 Units on a scale |
Secondary
Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period
Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3.
Time frame: Baseline to Day 169
Population: All participants who received at least 1 dose of study medication were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period | -0.62 Units on a scale |
| Intravenous (IV) Abatacept, 125 mg | Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period | -0.61 Units on a scale |
Secondary
Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period
The American College of Rheumatology (ACR) scores of 50 and 70 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score represents a percentage. To qualify for an ACR50 or ACR70 scores, the patient must have \>=50% or \>=70%, respectively, fewer tender joints and \>=50% or \>=70%, respectively, fewer swollen joints and show 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation).
Time frame: Day 169
Population: m= All participants who received at least 1 dose of study medication in short term period and had data available. n= participants with ACR50 or ACR70 response in the short term period. n/m= percentage
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period | ACR70 (n/m=22/59, 18/59) | 37.3 Percentage of participants |
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period | ACR50 (n/m=39/59, 37/59) | 66.1 Percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period | ACR50 (n/m=39/59, 37/59) | 62.7 Percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period | ACR70 (n/m=22/59, 18/59) | 30.5 Percentage of participants |
Secondary
Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period
EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (\<) 2.6.
Time frame: Day 169
Population: m=All randomized participants who received at least 1 dose of study medication and with LDAS and REM data available. n= number of participants with LDAS and REM. n/m=percentage of participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period | LDAS (n/m= 40/57, 38/57) | 70.2 Percentage of participants |
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period | REM (n/m= 29/57, 23/57) | 50.9 Percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period | LDAS (n/m= 40/57, 38/57) | 66.7 Percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period | REM (n/m= 29/57, 23/57) | 40.4 Percentage of participants |
Secondary
Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period
EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP\<2.6.
Time frame: Day 533
Population: m=All treated participants in the long term period in the analysis with available LDAS and REM data. n=number of participants with either EULAR-defined LDAS response or EULAR-defined REM response. n/m = percentage of participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period | LDAS (n/m= 45/52, 42/51) | 86.5 percentage of participants |
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period | REM (n/m= 33/52; 32/51) | 63.5 percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period | LDAS (n/m= 45/52, 42/51) | 82.4 percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period | REM (n/m= 33/52; 32/51) | 62.7 percentage of participants |
Secondary
Percentage of Participants With HAQ Response at Day 169 in the Short Term Period
The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. The HAQ-DI response is defined as a reduction of at least 0.30 units in HAQ score from baseline.
Time frame: Day 169
Population: N=All randomized participants who received at least 1 dose of study medication in short term period. n=number of participants with HAQ response in short term period; n/N=percentage of participants: 41/59 and 30/59
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Percentage of Participants With HAQ Response at Day 169 in the Short Term Period | 69.5 Percentage of participants |
| Intravenous (IV) Abatacept, 125 mg | Percentage of Participants With HAQ Response at Day 169 in the Short Term Period | 50.8 Percentage of participants |
Secondary
Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.
Time frame: Baseline to Day 169
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to AEs | 3 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related AEs | 31 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | SAEs | 4 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related SAEs | 3 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to SAEs | 3 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | AEs | 45 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Deaths | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related AEs | 35 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related SAEs | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | AEs | 49 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to AEs | 3 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Deaths | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to SAEs | 1 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | SAEs | 3 Participants |
Secondary
Short-term Period: 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 (mEq/L): \<0.95\*LLN or \>1.05\*ULN, or if preRX\<LLN, use \<0.95\*preRX or \>ULN, or if preRX\>ULN, use 1.05\*preRX or \<LLN; potassium (mEq/L): \<0.9\*LLN or \>1.1\*ULN, or if preRX\<LLN, use \<0.9\*preRX or \>ULN, or if preRX\>ULN, use 1.1\*preRX or \<LLN; chloride (mEq/L): \<0.75\*LLN or \>1.125\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; calcium (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.75\*preRX or \>ULN, or if preRX\>ULN, use 1.25\*preRX or \<LLN; phosphorus (mg/dL): \<0.75\*LLN or \>1.25\*ULN, or if preRX\<LLN, use \<0.67\*preRX or \>ULN, or if preRX\>ULN, use 1.33\*preRX or \<LLN.
Time frame: Baseline to Day 169
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Sodium, serum, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Calcium, total, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Potassium, serum, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Phosphorus, inorganic, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality | Chloride, serum, low | 0 Participants |
Secondary
Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
lower limit of normal(LLN); upper limit of normal(ULN); pretreatment(preRX). Hemoglobin (g/dL): \>3 g/dL decrease from preRX; hematocrit (%): \<0.75\*preRX; erythrocytes (\*10\^6 c/uL): \<0.75\*preRX; platelet count (\*10\^9 c/uL): \<0.67\*LLN or \>1.5\*ULN, of if preRX\<LLN, use 0.5\*preRX and \<100,000/mm\^3; leukocytes (\*10\^3 c/uL): \<0.75\*LLN or \>1.25\*ULN, or if preRX \<LLN, use \<0.8\*preRX or \>ULN, or if preRX\>ULN, use \>1.2\*preRX or \<LLN; neutrophils+bands (\*10\^3 c/uL): if value \<1.0\*10\^3 c/uL; eosinophils (\*10\^3 c/uL): if value \>0.750\*10\^3 c/uL; basophils (\*10\^3 c/uL): if value \>400/mm\^3; monocytes (\*10\^3 c/uL): if value \>2000/mm\^3; lymphocytes (\*10\^3 c/uL): if value \<0.750\*10\^3 c/uL or if value \>7.50\*10\^3 c/uL.
Time frame: Baseline to Day 169
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hematocrit, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Erythrocytes, high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Platelet count, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Platelet count, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Leukocytes, low | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Leukocytes, high | 2 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Neutrophils + bands (absolute), low | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Neutrophils + bands (absolute), high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Eosinophils (absolute), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Eosinophils (absolute), high | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Basophils (absolute), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Basophils (absolute), high | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Monocytes (absolute), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Monocytes (absolute), high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Lymphocytes (absolute), low | 8 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Lymphocytes (absolute), high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hemoglobin, low | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hemoglobin, high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hematocrit, high | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Erythrocytes, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Eosinophils (absolute), high | 2 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hematocrit, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Erythrocytes, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Lymphocytes (absolute), low | 10 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Erythrocytes, high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Basophils (absolute), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Platelet count, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hematocrit, high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Platelet count, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Basophils (absolute), high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Leukocytes, low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Lymphocytes (absolute), high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Leukocytes, high | 3 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Monocytes (absolute), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Neutrophils + bands (absolute), low | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hemoglobin, high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Neutrophils + bands (absolute), high | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Monocytes (absolute), high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Eosinophils (absolute), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality | Hemoglobin, low | 0 Participants |
Secondary
Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. alkaline phosphatase (ALP) (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; aspartate aminotransferase (AST) (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; alanine aminotransferase(ALT) (U/L): \>3\*ULN, or if preRX\>ULN, use \>4\*preRX; Gamma glutamyltransferase(GGT) (U/L): \>2\*ULN, or if preRX\>ULN, use \>3\*preRX; bilirubin (mg/dL): \>2\*ULN, or if preRX\>ULN, use \>4\*preRX; blood urea nitrogen (mg/dL): \>2\*preRX; creatinine (mg/dL): \>1.5\*preRX.
Time frame: Baseline to Day 169
Population: All randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alkaline phosphatase (ALP), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALP, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Aspartate aminotransferase (AST), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | AST, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alanine aminotransferase (ALT), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALT, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | G-glutamyl transferase (GGT), low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | GGT, high | 1 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, high | 0 Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, low | NA Participants |
| Subcutaneous (SC) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alkaline phosphatase (ALP), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | GGT, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALP, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Aspartate aminotransferase (AST), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | AST, high | 1 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Blood urea nitrogen, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Alanine aminotransferase (ALT), low | NA Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Bilirubin, total, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | ALT, high | 0 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | Creatinine, high | 3 Participants |
| Intravenous (IV) Abatacept, 125 mg | Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality | G-glutamyl transferase (GGT), low | NA Participants |