| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 169 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00091.5(81.3 to 97.2)
- OG00183.1(71.0 to 91.6)
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| 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). | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 169 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | All participants who received at least 1 dose of study medication were analyzed. | Posted | | Mean | 95% Confidence Interval | Units on a scale | | Baseline to Day 169 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Intravenous (IV) Abatacept, 125 mg | |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
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| 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. | All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed. | Posted | | Mean | 95% Confidence Interval | Units on a scale | | Baseline to 6 Months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 533 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 533 and up to 56 days following last dose in Long-Term period | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Intravenous (IV) Abatacept, 125 mg | |
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| 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. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
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| 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. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 533 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
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| 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. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 169 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 \ | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
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| 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. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 533 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 533 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period. | Posted | | Mean | 95% Confidence Interval | units on a scale | | Baseline to Day 533 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 533 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed. | Posted | | Mean | 95% Confidence Interval | units on a scale | | Baseline to Day 533 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Intravenous (IV) Abatacept, 125 mg |
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| 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 \ | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Baseline to Day 533 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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