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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,286
IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).
Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Paradise Valley, Arizona, United States
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Peoria, Arizona, United States
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Tucson, Arizona, United States
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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
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
Time frame: Days 1-169
Short-term Period: Number of Participants With AEs of Special Interest
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).
Time frame: Days 1-169
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
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.
Time frame: Days 1-169
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
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
Time frame: Days 1-169
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
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
Time frame: Days 1-169
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
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
Time frame: Days 1-169
Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Day 1 (Baseline) -Day 169
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)
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.
Time frame: Days 1-169
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
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
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Number of Participants With AEs of Special Interest
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).
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
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.
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
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
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
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
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
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
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
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
Time frame: BL, Day 365, Day 729
Long-term Period: Change From Baseline in Hematocrit Over Time
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).
Time frame: BL, Day 365, Day 729
Long-term Period: Change From Baseline in Erythrocytes Over Time
Erythrocytes NR= 3.80 - 5.50 \*10\^6 c/uL, MA is \<0.75 \* BL
Time frame: BL, Day 365, Day 729
Long-term Period: Change From Baseline in Platelets (PLT) Over Time
Erythrocytes NR= 3.80 - 5.50 \*10\^6 c/uL, MA is \<0.75 \* BL
Time frame: BL, Day 365, Day 729
Long-term Period: Change From Baseline in White Blood Cells Over Time
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
Time frame: BL, Day 365, Day 729
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
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
Time frame: BL, Day 365, Day 729
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
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.
Time frame: BL, Day 365, Day 729
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
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
Time frame: BL, Day 365, Day 729
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Measurements were taken in a seated position before and after abatacept infusion.
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Measurements were taken in a seated position before and after abatacept infusion.
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Mean Heart Rate (HR) Over Time
Time frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Long-term Period: Mean Temperature (T) Over Time
Time frame: 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 Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). A clinically significant response= decrease in DAS28 score of \>1.2 from baseline.
Time frame: BL, Day 169
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time frame: BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.
Time frame: 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)
hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.
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Time frame: BL, Day 169
Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.
Time frame: BL, Day 169
Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).
Time frame: BL, Day 169
Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response
HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Time frame: BL, Day 169
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
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time frame: BL
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time frame: BL, Day 169
Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Time frame: BL
Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Time frame: BL, Day 169
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). A clinically significant response= decrease in DAS28 score of \>1.2 from baseline.
Time frame: BL, 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
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time frame: BL (Day 0), 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
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.
Time frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813
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
The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time frame: 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
The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Time frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time frame: 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
The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Time frame: 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
hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Time frame: 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
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.
Time frame: 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
HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.
Time frame: BL (Day 0)
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.
Time frame: Days 365, 449, 533, 617, 729, 813
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
HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.
Time frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Time frame: BL, Days 365, 449, 533, 617, 729, 813
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
SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit
Time frame: BL (Day 0)
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
SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.
Time frame: Days 365 and 729
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
SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.
Time frame: BL (Day 0), Days 365, 729
LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA
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.
Time frame: Days 1-813