A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,286
- 试验地点
- 1
- 主要终点
- Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
研究概览
简要总结
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed double-blind portion of the IM101064 study.
- •Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
- •American College of Rheumatology (ACR) functional class I, II, III
- •Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months
排除标准
- •Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
- •History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
研究组 & 干预措施
Open-label Abatacept (ABA)-Previous User
In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
干预措施: Abatacept (Drug)
Open-label Abatacept (ABA)-Previous User
In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
干预措施: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) (Drug)
Open-label ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
干预措施: Abatacept (Drug)
Open-label ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
干预措施: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) (Drug)
Open-label ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
干预措施: Anti-Tumor Necrosing Factor (TNF) Therapy (Drug)
Long-term ABA
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
干预措施: Abatacept (Drug)
Long-term ABA
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
干预措施: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) (Drug)
结局指标
主要结局
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
时间窗: BL, Day 365, Day 729
HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is \>3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is \<0.9\* LLN/\>1.1\* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is \<0.9\* LLN, or if BL\<LLN then use \<0.75 BL
Long-term Period: Change From Baseline in Platelets (PLT) Over Time
时间窗: BL, Day 365, Day 729
Erythrocytes NR= 3.80 - 5.50 \*10\^6 c/uL, MA is \<0.75 \* BL
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\*ULN, or if BL\>ULN, use \>3\*BL; aspartate aminotransferase (AST): \>3\*ULN, or if BL\>ULN,use \>4\*BL; alanine aminotransferase (ALT): \>3\*ULN, or if BL\>ULN, use \>4\*BL; G-Glutamyl transferase (GGT): \>2\*ULN, or if BL\>ULN, use \>3\*BL; bilirubin: \>2\*ULN, or if BL\>ULN, use \>4\*BL; blood urea nitrogen (BUN): \>2\*BL; creatinine: \>1.5\*BL
Long-term Period: Number of Participants With AEs of Special Interest
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: \>3 g/dL decrease from BL; Hematocrit: \<0.75\*BL; Erythrocytes:\<0.75\*BL; Platelets: \<0.67\*LLN/\>1.5 \* ULN, or if BL\<LLN, use 0.5\*BL/\<100,000 mm\^3; Leukocytes: \<0.75\*LLN/\>1.25\*ULN, or if BL\<LLN, use \<0.8\*BL/\>ULN, or if BL\>ULN,use \>1.2\*BL/\<LLN; neutrophils+bands: \<1.0\*10\^3 c/uL; eosinophils: \>0.750\*10\^3 c/uL; basophils: \>400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750\*10\^3 c/uL/\>7.50\*10\^3 c/uL.
Long-term Period: Change From Baseline in White Blood Cells Over Time
时间窗: BL, Day 365, Day 729
Leukocytes NR=4.1 - 12.3\*10\^3 c/uL, MA is \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL/\>ULN, or if BL\>ULN then use \>1.2 \* BL/\<LLN. Neutrophils+bands MA is \<1.0 \* 10\^3 c/uL. Eosinophils MA is \>0.750 \* 10\^3 c/uL. Basophils MA is \> 400 mm\^3. Monocytes MA is \>2000 mm\^3. Lymphocytes MA is \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
时间窗: Days 1-169
Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use 0.5 \* BL/\<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL/\>ULN, or if BL\>ULN then use \>1.2 \* BL/\<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.
Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure
时间窗: Day 1 (Baseline) -Day 169
Long-term Period: Change From Baseline in Hematocrit Over Time
时间窗: BL, Day 365, Day 729
The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).
Long-term Period: Change From Baseline in Erythrocytes Over Time
时间窗: BL, Day 365, Day 729
Erythrocytes NR= 3.80 - 5.50 \*10\^6 c/uL, MA is \<0.75 \* BL
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
时间窗: BL, Day 365, Day 729
Na NR=132 - 147 mEq/L, MA is 95\* LLN/ \>1.05\* ULN, or if BL\<LLN then use 0.95\* BL or \>ULN, or if BL\>ULN then use\>1.05\* BL or \<LLN. K NR=3.3 - 5.5 mEq/L, MA is \<0.9\* LLN/\>1.1\* ULN,or if BL\<LLN then use 0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN. Cl NR=94 - 111 mEq/L, MA is \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use 0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN
Long-term Period: Mean Temperature (T) Over Time
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
时间窗: Days 1-169
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Short-term Period: Number of Participants With AEs of Special Interest
时间窗: Days 1-169
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
时间窗: Days 1-169
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
时间窗: Days 1-169
Marked abnormality criteria:Sodium (Na): \<0.95\* LLN/ \>1.05\* ULN,or if BL\<LLN then use 0.95\* BL or \>ULN,or if BL\>ULN then use\>1.05\* BL or \<LLN; potassium (K): \<0.9\* LLN/\>1.1\* ULN,or if BL\<LLN then use 0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; chloride: \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use 0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; calcium (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use 0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
时间窗: Days 1-169
Marked abnormality criteria: serum glucose (Glu):\<65 mg/dL/ \>220 mg/dL; fasting serum Glu: \<0.8\* LLN/\>1.5\* ULN, or if BL\<LLN then use 0.8\* BL or \>ULN, or if BL\>ULN then use \>2.0\* BL or \<LLN; total protein: \<0.9\* LLN/\>1.1\* ULN; albumin: \<0.9\* LLN,or if BL\<LLN then use \<0.75 BL; uric acid: \>1.5\* ULN, or if BL\>ULN then use \>2\* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3
Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)
时间窗: Days 1-169
Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Marked abnormality criteria:Sodium (Na): \<0.95\* LLN/ \>1.05\* ULN,or if BL\<LLN then use 0.95\* BL or \>ULN,or if BL\>ULN then use\>1.05\* BL or \<LLN; potassium (K): \<0.9\* LLN/\>1.1\* ULN,or if BL\<LLN then use 0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; chloride: \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use 0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; calcium (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use 0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
时间窗: BL, Day 365, Day 729
Bilirubin NR=0.2-1.2 mg/dL, MA: \>2\* ULN, or if BL\>ULN then use \>4\* BL. BUN NR=4.0-24.0 mg/dL, MA: \>2\*BL. Creatinine NR=0.4-1.2 mg/dL, MA: \>1.5\*BL. Ca NR=8.8-10.2 mg/dL, MA: \<0.8\*LLN/\>1.2\*ULN, or if BL\<LLN then use 0.75\*BL or \>ULN, or if BL\>ULN then use\>1.25\*BL or \<LLN. P NR=2.8-4.0 mg/dL, MA: \<0.75\*LLN/ \>1.25\*ULN, or if BL\<LLN then use 0.67\*BL or \>ULN, or if BL\>ULN then use\>1.33\*BL or \<LLN. Glu MA: \<65 mg/dL/ \>220 mg/dL. Uric acid MA: \>1.5\*ULN, or if BL\>ULN then use \>2\*BL.
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Marked abnormality criteria: serum glucose (Glu):\<65 mg/dL/ \>220 mg/dL; fasting serum Glu: \<0.8\* LLN/\>1.5\* ULN, or if BL\<LLN then use 0.8\* BL or \>ULN, or if BL\>ULN then use \>2.0\* BL or \<LLN; total protein: \<0.9\* LLN/\>1.1\* ULN; albumin: \<0.9\* LLN,or if BL\<LLN then use \<0.75 BL; uric acid: \>1.5\* ULN, or if BL\>ULN then use \>2\* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
时间窗: BL, Day 365, Day 729
HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is \>3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is \<0.9\* LLN/\>1.1\* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is \<0.9\* LLN, or if BL\<LLN then use \<0.75 BL
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Measurements were taken in a seated position before and after abatacept infusion.
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Measurements were taken in a seated position before and after abatacept infusion.
Long-term Period: Mean Heart Rate (HR) Over Time
时间窗: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
次要结局
- Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label(BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)(BL, Day 169)
- Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169(BL, Day 169)
- Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response(BL, Day 169)
- Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)(BL)
- Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)(BL, Day 169)
- Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term(Days 365, 449, 533, 617, 729, 813)
- Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label(BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)(BL, Day 169)
- Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)(BL, Day 169)
- Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time(BL, Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores(BL, Day 169)
- Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA(Days 1-813)
- Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores(BL)
- Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term(BL (Day 0))
- Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term(BL (Day 0))
- Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term(BL (Day 0), Days 365, 729)
- Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time(BL, Days 365, 449, 533, 617, 729, 813)
- Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term(Days 365 and 729)
- Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term(BL (Day 0), Days 365, 449, 533, 617, 729, 813)