Rheumatoid Arthritis (RA)
Conditions
Brief summary
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept
Interventions
DRUGabatacept
solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open
DRUGMethotrexate (MTX)
Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Rheumatoid Arthritis * Subjects Global Disease Assessment of greater than equal to 20 mm on a visual analog scale * Discontinue all Biologics and Disease-modifying antirheumatic drugs (DMARDS) except for methotrexate
Exclusion criteria
* Received treatment with rituximab * Subjects who have received treatment with immunoadsorbtion columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study | Day 113 | ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25. |
| Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose. | ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25. |
| Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose. | The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10. |
| Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results) | Day 113. | ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25. |
| Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results) | Day 113. | The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10. |
| Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results) | Baseline and on day 15, 29, 43, 57, 85 and 113 | ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25. |
| Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results) | Baseline and day 15, 29, 43, 57, 85 and 113. | The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AEs of Special Interest During the ST Study | Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded. |
| Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first. | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: \>3 g/dL decrease from pre-treatment (pre Rx); hematocrit: \<0.75 \* pre-Rx value; platelet count: \<0.67 \* (LLN -lower limit of normal) (or, if pre-Rx value \<LLN, then \<0.5 \* pre-Rx value and \<100,000/mm\^3); leukocytes: \<0.75 \* LLN or \>1.25 \* ULN (or, if pre-Rx value \<LLN, then \<0.8 \* pre-Rx or \>(ULN -upper limit of normal) ; erythrocytes: \<0.75 \* pre Rx. |
| Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first. | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): \<1.00 \* 10\^3cells/microlitre (uL); lymphocytes (absolute): \<0.75 \* 10\^3 cells/uL or \>7.50 \* 10\^3 cells/uL; monocytes (absolute): \>2.00 \* 10\^3 cells/uL; basophils (absolute): \>0.40 \* 10\^3 cells/uL; eosinophils (absolute): \>0.75 \* 10\^3 cells/uL. |
| Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first. | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: \>2.0 \* ULN (if pre-Rx \> ULN, then \>3 \* pre-Rx); AST, ALT: \> 3 \* ULN (if pre-Rx \> ULN, then \> 4 \* pre-Rx); bilirubin (total): \>2 \* ULN, or if pre Rx \> ULN then \>4 \* Pre Rx; BUN : \>2 \* pre Rx; GGT : \>2 \* ULN, or if pre Rx \> ULN then \>3 \* pre Rx. |
| Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first. | MAs= laboratory measurements marked as abnormal: creatinine: \>1.5 \* pre-Rx; sodium (serum):\<0.95 \* LLN or \>1.05 \* ULN (if pre-Rx \< LLN, then \<0.95 \* pre-Rx or \>1.05 \* ULN. If pre-Rx \> ULN, then \>0.95 \* pre-Rx or \< ULN); potassium (serum):\<0.9 \* LLN or \>1.1 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN; chloride (serum),protein (total):\<0.9 \* LLN or \>1.1 8 ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>1.1 \* pre-Rx or \< LLN); calcium (total): \<0.8 \* LLN or \>1.2 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>0.75 \* pre-Rx or \< ULN). |
| Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first. | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): \<0.8 \* LLN or \>1.5 ULN (if pre-Rx \<LLN, then \<2.0 \* pre-Rx or \>ULN; albumin: \<0.9 \* LLN (if pre-Rx \< LLN, then \<0.75 \* pre-Rx); uric acid: \>1.5 \* ULN (if pre-Rx \> ULN, then \>2.0 \* pre-Rx); phosphorous (inorganic):\<0.75 \* LLN or \>1.25 \* ULN (if pre-Rx \< ULN, then \<0.67 \* pre-Rx or \< ULN. If pre-Rx \> ULN, then \>1.33 \* re-Rx or \< LLN); glucose (serum): \<65 mg/dL or \>220 mg/dL. |
| Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first. | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: \>= 2+ (or, if value \>= 4, or if pre-Rx value = 0 or 0.5, then \>= 2x or if pre-Rx value =1, then \>= 3, or if pre-Rx = 2 or 3, then \>= 4). |
| Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study | Day 113. | ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160. |
| Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study | Day 113. | Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values. |
| Number of Participants With Clinically Meaningful Vital Signs During the ST Study | At screening and on days 1,15,29,43, 57, 85 and 113. | Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful. |
| Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Days 1, 15, 29, 43, 57, 85 and 113. | Cmin serum abatacept concentration was obtained directly from the concentration-time data. |
| Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168 | The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region. |
| Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study | Baseline, Day 113, Day 1345 | DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study. |
| Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study | Baseline and Month 4 (Day113). | DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* VAS + 0.96. |
| Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE | Day 113, Day 1345 | DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113. |
| Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study | Baseline, Day 113, Day 1345 | HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The 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. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study. |
| Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy | Baseline, Day 113, Day 1345 | HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study. |
| Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study | Continuously from start of LTE period up to 7 days post the last dose | RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (\>= 15 IU/mL resulted in a positive result). |
| Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup | Baseline, Day 113, Day 1345 | Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study. |
| Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup | Day 113, Day 1345 | Remission was defined as DAS 28-CRP \< 2.6 and LDA was defined as DAS 28-CRP \<= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies. |
| Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | Continuously from start of LTE Study up to 56 days post the last dose | AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. |
| Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study | Continuously from start of LTE Study up to 56 days post the last dose | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded. |
| Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Continuously from start of LTE Study up to 56 days post the last dose | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: \>3 g/dL decrease from pre-treatment (pre Rx); hematocrit: \<0.75 \* pre-Rx value; platelet count: \<0.67 \* (LLN -lower limit of normal) (or, if pre-Rx value \<LLN, then \<0.5 \* pre-Rx value and \<100,000/mm\^3); leukocytes: \<0.75 \* LLN or \>1.25 \* ULN (or, if pre-Rx value \<LLN, then \<0.8 \* pre-Rx or \>(ULN -upper limit of normal) ; erythrocytes: \<0.75 \* pre Rx. Neutrophils + bands (absolute): \<1.00 \* 10\^3cells/microlitre (uL); lymphocytes (absolute): \<0.75 \* 10\^3 cells/uL or \>7.50 \* 10\^3 cells/uL; monocytes (absolute): \>2.00 \* 10\^3 cells/uL; basophils (absolute): \>0.40 \* 10\^3 cells/uL; eosinophils (absolute): \>0.75 \* 10\^3 cells/uL. |
| Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | Continuously from start of LTE Study up to 56 days post the last dose | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: \>2.0 \* ULN (if pre-Rx \> ULN, then \>3 \* pre-Rx); AST, ALT: \> 3 \* ULN (if pre-Rx \> ULN, then \> 4 \* pre-Rx); bilirubin (total): \>2 \* ULN, or if pre Rx \> ULN then \>4 \* Pre Rx; BUN : \>2 \* pre Rx; GGT : \>2 \* ULN, or if pre Rx \> ULN then \>3 \* pre Rx; creatinine: \>1.5 \* pre-Rx. |
| Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | Continuously from start of LTE Study up to 56 days post the last dose | Sodium (serum):\<0.95 \* LLN or \>1.05 \* ULN (if pre-Rx \< LLN, then \<0.95 \* pre-Rx or \>1.05 \* ULN. If pre-Rx \> ULN, then \>0.95 \* pre-Rx or \< ULN); potassium (serum):\<0.9 \* LLN or \>1.1 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN; chloride (serum),protein (total):\<0.9 \* LLN or \>1.1 8 ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>1.1 \* pre-Rx or \< LLN); calcium (total): \<0.8 \* LLN or \>1.2 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>0.75 \* pre-Rx or \< ULN); phosphorous (inorganic):\<0.75 \* LLN or \>1.25 \* ULN (if pre-Rx \< ULN, then \<0.67 \* pre-Rx or \< ULN. If pre-Rx \> ULN, then \>1.33 \* re-Rx or \<LLN); glucose (serum): \<65 mg/dL or \>220 mg/dL; Glucose (fasting serum): \<0.8 \* LLN or \>1.5 ULN (if pre-Rx \<LLN, then \<2.0 \* pre-Rx or \>ULN; albumin: \<0.9 \* LLN (if pre-Rx \< LLN, then \<0.75 \* pre-Rx); uric acid: \>1.5 \* ULN (if pre-Rx \> ULN, then \>2.0 \* pre-Rx). |
| Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study | Continuously from start of LTE Study up to 56 days post the last dose | MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: \>= 2+ (or, if value \>= 4, or if pre-Rx value = 0 or 0.5, then \>= 2x or if pre-Rx value =1, then \>= 3, or if pre-Rx = 2 or 3, then \>= 4). |
| Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study | Baseline, Day 113, Day 1345 | A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study. |
| Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study | Day 113. | A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. |
| Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study | Baseline and Month 4 (Day 113). | HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The 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. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. |
| Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Baseline and Month 4 (Day113). | HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The 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. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. |
| Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Baseline and Day 113. | RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (\>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided. |
| Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. | AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded. |
| Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study | Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. | Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy. |
Countries
Australia, Mexico, South Africa, United States
Participant flow
Recruitment details
Short term (ST) Study results (2 arms) were released in 2010. Final long term extension (LTE) results (1 arm with pooled data), up to 2014, are now included. During the LTE Study, 125 mg abatacept, was continued to be self-administered weekly and adjustments to RA medications including MTX were permitted at investigators discretion.
Pre-assignment details
119 participants enrolled;100 treated in the ST Study. Reasons not treated: 17 no longer met criteria, 2 withdrew consent. 96 completed ST treatment but only 95 completed Primary endpoint evaluation. 90 enrolled in LTE Study. Reasons why participants did not enroll in LTE Study: 2 lack of efficacy, 2 had adverse events, 1 no longer met criteria.
Participants by arm
| Arm | Count |
|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. | 51 |
| SC Abatacept Monotherapy Cohort In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. | 49 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Long Term Extension (LTE) Study | Adverse Event | 0 | 9 |
| Long Term Extension (LTE) Study | Lack of Efficacy | 0 | 14 |
| Long Term Extension (LTE) Study | Lost to Follow-up | 0 | 3 |
| Long Term Extension (LTE) Study | Other | 0 | 2 |
| Long Term Extension (LTE) Study | Poor/Non-Compliance | 0 | 1 |
| Long Term Extension (LTE) Study | Withdrawal by Subject | 0 | 2 |
| Short Term Study (4 Months) | Adverse Event | 1 | 0 |
| Short Term Study (4 Months) | Lack of Efficacy | 0 | 2 |
| Short Term Study (4 Months) | primary endpoint evaluation not complete | 0 | 1 |
| Short Term Study (4 Months) | Withdrawal of consent | 0 | 1 |
Baseline characteristics
| Characteristic | Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | SC Abatacept Monotherapy Cohort | Total |
|---|---|---|---|
| Age, Continuous | 55.0 years FULL_RANGE 11.5 | 54.0 years FULL_RANGE 10.2 | 54.0 years FULL_RANGE 10.9 |
| Disease activity score C-reactive protein (DAS 28-CRP) | 5.1 Units on a scale STANDARD_DEVIATION 1.2 | 5.8 Units on a scale STANDARD_DEVIATION 1.5 | 5.4 Units on a scale STANDARD_DEVIATION 1.4 |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.3 Units on a scale STANDARD_DEVIATION 0.7 | 1.5 Units on a scale STANDARD_DEVIATION 0.7 | 1.4 Units on a scale STANDARD_DEVIATION 0.7 |
| Physician global assessment per VAS | 51.6 mm STANDARD_DEVIATION 16.4 | 63.9 mm STANDARD_DEVIATION 20.5 | 57.7 mm STANDARD_DEVIATION 19.5 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 10 participants | 11 participants |
| Race/Ethnicity, Customized Black | 7 participants | 4 participants | 11 participants |
| Race/Ethnicity, Customized Other races | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 42 participants | 34 participants | 76 participants |
| Rheumatoid Factor (RF) Status Negative | 15 participants | 15 participants | 30 participants |
| Rheumatoid Factor (RF) Status Positive | 35 participants | 32 participants | 67 participants |
| Rheumatoid Factor (RF) Status Unknown | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 34 Participants | 41 Participants | 75 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 25 Participants |
| Subject global assessment per VAS | 60.4 mm STANDARD_DEVIATION 18.9 | 69.9 mm STANDARD_DEVIATION 22.6 | 65.0 mm STANDARD_DEVIATION 21.2 |
| Subject pain assessment per Visual Analogue Scale(VAS) | 63.3 millimeters (mm) STANDARD_DEVIATION 19.1 | 70.5 millimeters (mm) STANDARD_DEVIATION 19.6 | 66.8 millimeters (mm) STANDARD_DEVIATION 19.6 |
| Swollen joints | 16.2 swollen joints STANDARD_DEVIATION 12 | 18.3 swollen joints STANDARD_DEVIATION 12.2 | 17.2 swollen joints STANDARD_DEVIATION 12.1 |
| Tender joints | 23.9 tender joints STANDARD_DEVIATION 18 | 24.3 tender joints STANDARD_DEVIATION 14.2 | 24.1 tender joints STANDARD_DEVIATION 16.2 |
| Weight continuous | 84.6 kilogram (Kg) STANDARD_DEVIATION 18.8 | 81.6 kilogram (Kg) STANDARD_DEVIATION 22.4 | 83.1 kilogram (Kg) STANDARD_DEVIATION 20.6 |
| Weight customized > 100 Kg | 11 participants | 10 participants | 21 participants |
| Weight customized 60 - 100 Kg | 36 participants | 31 participants | 67 participants |
| Weight customized < 60 Kg | 4 participants | 8 participants | 12 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 51 | 13 / 49 | 70 / 90 |
| serious Total, serious adverse events | 2 / 51 | 3 / 49 | 34 / 90 |
Outcome results
Primary
Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results)
ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25.
Time frame: Baseline and on day 15, 29, 43, 57, 85 and 113
Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.
Primary
Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results)
The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10.
Time frame: Baseline and day 15, 29, 43, 57, 85 and 113.
Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.
Primary
Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results)
ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25.
Time frame: Day 113.
Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive Immunoglobulin G (IMG) samples on Day 113, therefore this analysis was not necessary.
Primary
Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results)
The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10.
Time frame: Day 113.
Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive IMG samples on Day 113, therefore this analysis was not necessary.
Primary
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study
ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25.
Time frame: Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose.
Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n = those participants who were evaluated for this measure at each timepoint, for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 15, (n= 51,47) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 113, (n= 50,45) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 43, (n= 50,48) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | 28 Days last post dose, (n=2,3) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | 56 Days last post dose, (n=2,3) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 57, (n= 50,47) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | 85 Days last post dose, (n=4,4) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 29, (n= 50,48) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Overall post visits, (n=4,4) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 85, (n= 50,47) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Overall, (n=51,49) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Overall on Treatment visits, (n=51,49) | 2 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Overall, (n=51,49) | 2 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Overall on Treatment visits, (n=51,49) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 15, (n= 51,47) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 29, (n= 50,48) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 43, (n= 50,48) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 57, (n= 50,47) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 85, (n= 50,47) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Day 113, (n= 50,45) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | 28 Days last post dose, (n=2,3) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | 56 Days last post dose, (n=2,3) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | 85 Days last post dose, (n=4,4) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study | Overall post visits, (n=4,4) | 1 participants |
Primary
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study
ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 25.
Time frame: Day 113
Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study | 0 participants |
Primary
Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study
The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10.
Time frame: Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.
Population: Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n=number of participants who were evaluated for this measure at each timepoint, for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 43, (n= 50,48) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | 28 Days last post dose, (n=2,3) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 85, (n= 50,47) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | 56 Days last post dose, (n=2,3) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 29, (n= 50,48) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | 85 Days last post dose, (n=4,4) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 113, (n=50,45) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Overall post visits, (n=4,4) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 57, (n= 50,47) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Overall, (n=51,49) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Overall on Treatment visits, (n=51,49) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 15, (n= 51,47) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Overall on Treatment visits, (n=51,49) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 29, (n= 50,48) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 43, (n= 50,48) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 57, (n= 50,47) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 85, (n= 50,47) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 113, (n=50,45) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Day 15, (n= 51,47) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | 28 Days last post dose, (n=2,3) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | 56 Days last post dose, (n=2,3) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | 85 Days last post dose, (n=4,4) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Overall post visits, (n=4,4) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study | Overall, (n=51,49) | 2 participants |
Secondary
Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study
HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The 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. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.
Time frame: Baseline and Month 4 (Day113).
Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period. n is the number of participants with baseline and post-baseline values.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Eating, (n= 50,46) | -0.28 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Reaching, (n= 49,46) | -0.24 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Hygiene, (n= 49,46) | -0.33 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Walking, (n= 50,46) | -0.26 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Gripping, (n= 49,46) | -0.31 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Arising, (n= 50,46) | -0.26 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Activities, (n= 49,46) | -0.39 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Dressing and Grooming, (n= 50,46) | -0.44 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Activities, (n= 49,46) | -0.67 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Dressing and Grooming, (n= 50,46) | -0.57 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Walking, (n= 50,46) | -0.54 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Arising, (n= 50,46) | -0.59 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Eating, (n= 50,46) | -0.57 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Hygiene, (n= 49,46) | -0.43 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Reaching, (n= 49,46) | -0.50 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study | Gripping, (n= 49,46) | -0.76 Units on a scale |
Secondary
Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup
Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study.
Time frame: Baseline, Day 113, Day 1345
Population: Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies and who had values at Baseline, Day 113, and Day 1345, were evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup | DAS-CRP at Day 113 (n=31) | -2.42 units on a scale | Standard Error 0.29 |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup | DAS-CRP at Day 1345 (n=23) | -2.58 units on a scale | Standard Error 0.3 |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup | HAQ-DI at Day 113 (n=32) | -0.60 units on a scale | Standard Error 0.1 |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup | HAQ-DI at Day 1345 (n=25) | -0.65 units on a scale | Standard Error 0.12 |
Secondary
Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* VAS + 0.96.
Time frame: Baseline and Month 4 (Day113).
Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study | -1.67 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study | -1.94 Units on a scale |
Secondary
Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study.
Time frame: Baseline, Day 113, Day 1345
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had DAS28-CRP values at Baseline, Day 113 and Day 1345, were evaluated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study | Day 113 (n=88) | -1.89 Units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study | Day 1345 (n=61) | -2.39 Units on a scale |
Secondary
Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study
HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The 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. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study.
Time frame: Baseline, Day 113, Day 1345
Population: Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study | HAQ-DI at Day 113 (n=89) | -0.47 units on a scale |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study | HAQ-DI at Day 1345 (n=64) | -0.56 units on a scale |
Secondary
Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study
HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The 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. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.
Time frame: Baseline and Month 4 (Day 113).
Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study | -0.31 Units on a scale |
| SC Abatacept Monotherapy Cohort | Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study | -0.58 Units on a scale |
Secondary
Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study
RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (\>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided.
Time frame: Baseline and Day 113.
Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Positive at Baseline, negative at Day 113 | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Positive at Baseline, positive at Day 113 | 32 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Negative at Baseline, negative at Day 113 | 12 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Negative at Baseline, positive at Day 113 | 2 participants |
| SC Abatacept Monotherapy Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Negative at Baseline, positive at Day 113 | 0 participants |
| SC Abatacept Monotherapy Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Positive at Baseline, negative at Day 113 | 1 participants |
| SC Abatacept Monotherapy Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Negative at Baseline, negative at Day 113 | 15 participants |
| SC Abatacept Monotherapy Cohort | Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study | Positive at Baseline, positive at Day 113 | 29 participants |
Secondary
Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study
Cmin serum abatacept concentration was obtained directly from the concentration-time data.
Time frame: Days 1, 15, 29, 43, 57, 85 and 113.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period. n=those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 15, (n= 40,41) | 13.69 microgram/mL |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 29, (n= 49,45) | 19.39 microgram/mL |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 43, (n= 41,38) | 23.40 microgram/mL |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 57, (n= 48,38) | 24.38 microgram/mL |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 85, (n= 47,39) | 28.77 microgram/mL |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 113, (n=46,37) | 28.46 microgram/mL |
| SC Abatacept Monotherapy Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 85, (n= 47,39) | 20.38 microgram/mL |
| SC Abatacept Monotherapy Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 15, (n= 40,41) | 11.23 microgram/mL |
| SC Abatacept Monotherapy Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 57, (n= 48,38) | 21.71 microgram/mL |
| SC Abatacept Monotherapy Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 29, (n= 49,45) | 15.64 microgram/mL |
| SC Abatacept Monotherapy Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 113, (n=46,37) | 23.74 microgram/mL |
| SC Abatacept Monotherapy Cohort | Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study | Day 43, (n= 41,38) | 18.06 microgram/mL |
Secondary
Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup
Remission was defined as DAS 28-CRP \< 2.6 and LDA was defined as DAS 28-CRP \<= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
Time frame: Day 113, Day 1345
Population: Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies, and who had values at Day 113 and Day 1345, were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup | Remission at Day 113 (n=32) | 14 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup | Remission at Day 1345 (n=24) | 9 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup | LDA at Day 113 (n=32) | 18 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup | LDA at Day 1345 (n=24) | 13 participants |
Secondary
Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE
DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113.
Time frame: Day 113, Day 1345
Population: Participants who received at least 1 dose of abatacept in the LTE study and who had values at Day 113 and Day 1345, were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE | LDA at Day 1345 (n=63) | 37 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE | Remission at Day 113 (n=90) | 28 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE | Remission at Day 1345 (n=63) | 28 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE | LDA at Day 113 (n=90) | 45 participants |
Secondary
Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study
AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded.
Time frame: Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | SAEs | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | All SAEs Leading to Discontinuation | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | AEs | 37 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | All AEs Leading to Discontinuation | 3 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | Deaths | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | All AEs Leading to Discontinuation | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | Deaths | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | SAEs | 3 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | AEs | 32 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study | All SAEs Leading to Discontinuation | 1 participants |
Secondary
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study
AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing.
Time frame: Continuously from start of LTE Study up to 56 days post the last dose
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE period, were evaluated. Includes all deaths reported during the LTE including those that occurred greater than 56 days after the last dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | Deaths | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | SAEs | 34 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | Related SAEs | 6 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | Discontinued due to SAEs | 3 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | AEs | 86 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | Related AEs | 34 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study | Discontinued due to AEs | 8 participants |
Secondary
Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study
Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy.
Time frame: Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study | Drug-related AEs | 14 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study | Drug-related SAEs | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study | Drug-related AEs | 12 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study | Drug-related SAEs | 1 participants |
Secondary
Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study
The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of \< 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region.
Time frame: Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had values at each specified timepoint, were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Days 897, 981 (n=66, 58) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1093 (n=65) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1177 (n=8) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1261 (n=57) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1345 (n=24) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1457 (n=59) | 3 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1541 (n=24) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1625 (n=18) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Days 1709, 1821 (n=2, 11) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 1989 (n=13) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Days 197, 281, 365, 449 (n=86, 87, 85, 79) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Day 533 (n=76) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Days 617, 729, 813 (n=74, 70, 66) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Overall on Treatment (n=88) | 11 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | 28 days post last dose (n=18) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | 56 days post last dose (n=15) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | 85 days post last dose (n=16) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | 168 days post last dose (n=3) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Overall post last dose visits (n=23) | 4 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study | Overall (n=90) | 13 participants |
Secondary
Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.
Time frame: Continuously from start of LTE Study up to 56 days post the last dose
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE Study, were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study | Infections | 69 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study | Autoimmune Disorders | 5 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study | Malignancies | 4 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study | Local Injection Site Reactions | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study | Systemic Injection Reaction | 12 participants |
Secondary
Number of Participants With AEs of Special Interest During the ST Study
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.
Time frame: Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the ST Study | Malignant neoplasm | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the ST Study | Local injection reactions | 3 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the ST Study | Autoimmune disorders | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the ST Study | Systemic injection reactions | 4 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With AEs of Special Interest During the ST Study | Infections | 18 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With AEs of Special Interest During the ST Study | Systemic injection reactions | 4 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With AEs of Special Interest During the ST Study | Infections | 14 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With AEs of Special Interest During the ST Study | Malignant neoplasm | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With AEs of Special Interest During the ST Study | Autoimmune disorders | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With AEs of Special Interest During the ST Study | Local injection reactions | 4 participants |
Secondary
Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study
Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values.
Time frame: Day 113.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study | Negative | 41 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study | Positive | 4 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study | Positive | 8 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study | Negative | 37 participants |
Secondary
Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study
ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160.
Time frame: Day 113.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study | Negative | 36 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study | Positive | 11 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study | Negative | 32 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study | Positive | 12 participants |
Secondary
Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study
A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline.
Time frame: Day 113.
Population: All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study | 30 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study | 30 participants |
Secondary
Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study
A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study.
Time frame: Baseline, Day 113, Day 1345
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had values at Baseline, Day 113 and Day 1345, were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study | Day 113 (n=88) | 59 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study | Day 1345 (n=61) | 43 participants |
Secondary
Number of Participants With Clinically Meaningful Vital Signs During the ST Study
Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful.
Time frame: At screening and on days 1,15,29,43, 57, 85 and 113.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Clinically Meaningful Vital Signs During the ST Study | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Clinically Meaningful Vital Signs During the ST Study | 0 participants |
Secondary
Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy
HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study.
Time frame: Baseline, Day 113, Day 1345
Population: Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy | HAQ DI Response at Day 113 (n=89) | 53 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy | HAQ DI Response at Day 1345 (n=64) | 41 participants |
Secondary
Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: \>3 g/dL decrease from pre-treatment (pre Rx); hematocrit: \<0.75 \* pre-Rx value; platelet count: \<0.67 \* (LLN -lower limit of normal) (or, if pre-Rx value \<LLN, then \<0.5 \* pre-Rx value and \<100,000/mm\^3); leukocytes: \<0.75 \* LLN or \>1.25 \* ULN (or, if pre-Rx value \<LLN, then \<0.8 \* pre-Rx or \>(ULN -upper limit of normal) ; erythrocytes: \<0.75 \* pre Rx. Neutrophils + bands (absolute): \<1.00 \* 10\^3cells/microlitre (uL); lymphocytes (absolute): \<0.75 \* 10\^3 cells/uL or \>7.50 \* 10\^3 cells/uL; monocytes (absolute): \>2.00 \* 10\^3 cells/uL; basophils (absolute): \>0.40 \* 10\^3 cells/uL; eosinophils (absolute): \>0.75 \* 10\^3 cells/uL.
Time frame: Continuously from start of LTE Study up to 56 days post the last dose
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Low Hemoglobin (n=90) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Low Hematocrit (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Low Erythrocytes (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Low Platelet Count (n=89) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | High Platelet Count (n=89) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Low Leukocytes (n=90) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | High Leukocytes (n=90) | 5 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Low Neutrophils + bands | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | Low Lymphocytes (n=90) | 6 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | High Lymphocytes (n=90) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | High Monocytes (n=90) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | High Basophils (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study | High Eosinophils (n=90) | 13 participants |
Secondary
Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: \>3 g/dL decrease from pre-treatment (pre Rx); hematocrit: \<0.75 \* pre-Rx value; platelet count: \<0.67 \* (LLN -lower limit of normal) (or, if pre-Rx value \<LLN, then \<0.5 \* pre-Rx value and \<100,000/mm\^3); leukocytes: \<0.75 \* LLN or \>1.25 \* ULN (or, if pre-Rx value \<LLN, then \<0.8 \* pre-Rx or \>(ULN -upper limit of normal) ; erythrocytes: \<0.75 \* pre Rx.
Time frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Hemoglobin | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Hematocrit | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Platelet Count | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | High Platelet Count | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | High Leukocytes | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Erythrocytes | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | High Leukocytes | 2 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Hemoglobin | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | High Platelet Count | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Hematocrit | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Erythrocytes | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes | Low Platelet Count | 0 participants |
Secondary
Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): \<1.00 \* 10\^3cells/microlitre (uL); lymphocytes (absolute): \<0.75 \* 10\^3 cells/uL or \>7.50 \* 10\^3 cells/uL; monocytes (absolute): \>2.00 \* 10\^3 cells/uL; basophils (absolute): \>0.40 \* 10\^3 cells/uL; eosinophils (absolute): \>0.75 \* 10\^3 cells/uL.
Time frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept)in the ST period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Monocytes (absolute) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Eosinophils (absolute) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Lymphocytes (absolute) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | Low Neutrophils + Bands (absolute) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Basophils (absolute) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | Low Lymphocytes (absolute) | 3 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Basophils (absolute) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Lymphocytes (absolute) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Monocytes (absolute) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | Low Lymphocytes (absolute) | 3 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | High Eosinophils (absolute) | 2 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) | Low Neutrophils + Bands (absolute) | 0 participants |
Secondary
Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN)
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: \>2.0 \* ULN (if pre-Rx \> ULN, then \>3 \* pre-Rx); AST, ALT: \> 3 \* ULN (if pre-Rx \> ULN, then \> 4 \* pre-Rx); bilirubin (total): \>2 \* ULN, or if pre Rx \> ULN then \>4 \* Pre Rx; BUN : \>2 \* pre Rx; GGT : \>2 \* ULN, or if pre Rx \> ULN then \>3 \* pre Rx.
Time frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High ALP | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High AST | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High ALT | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High Bilirubin (total) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High BUN | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High GGT | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High BUN | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High ALP | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High Bilirubin (total) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High AST | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High GGT | 2 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) | High ALT | 0 participants |
Secondary
Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total)
MAs= laboratory measurements marked as abnormal: creatinine: \>1.5 \* pre-Rx; sodium (serum):\<0.95 \* LLN or \>1.05 \* ULN (if pre-Rx \< LLN, then \<0.95 \* pre-Rx or \>1.05 \* ULN. If pre-Rx \> ULN, then \>0.95 \* pre-Rx or \< ULN); potassium (serum):\<0.9 \* LLN or \>1.1 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN; chloride (serum),protein (total):\<0.9 \* LLN or \>1.1 8 ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>1.1 \* pre-Rx or \< LLN); calcium (total): \<0.8 \* LLN or \>1.2 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>0.75 \* pre-Rx or \< ULN).
Time frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Calcium (total) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Sodium (serum) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Chloride (serum) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Potassium (serum) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Calcium (total) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Creatinine | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Chloride (serum) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Potassium (serum) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Sodium (serum) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Protein (total) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Protein (total) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Protein (total) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Chloride (serum) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Protein (total) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Chloride (serum) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Calcium (total) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Creatinine | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Sodium (serum) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Sodium (serum) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Calcium (total) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | Low Potassium (serum) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) | High Potassium (serum) | 0 participants |
Secondary
Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): \<0.8 \* LLN or \>1.5 ULN (if pre-Rx \<LLN, then \<2.0 \* pre-Rx or \>ULN; albumin: \<0.9 \* LLN (if pre-Rx \< LLN, then \<0.75 \* pre-Rx); uric acid: \>1.5 \* ULN (if pre-Rx \> ULN, then \>2.0 \* pre-Rx); phosphorous (inorganic):\<0.75 \* LLN or \>1.25 \* ULN (if pre-Rx \< ULN, then \<0.67 \* pre-Rx or \< ULN. If pre-Rx \> ULN, then \>1.33 \* re-Rx or \< LLN); glucose (serum): \<65 mg/dL or \>220 mg/dL.
Time frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Uric Acid (n=51; n=49) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Phosphorous (inorganic) (n=51; n=49) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Phosphorous (inorganic) (n=51; n=49) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Glucose (Fasting Serum) (n=8; n=21) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Glucose (Fasting Serum) (n=8; n=21) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Albumin (n=51; n=49) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Glucose (Serum) (n=51; n=49) | 6 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Glucose(Serum) (n=51; n=49) | 2 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Glucose(Serum) (n=51; n=49) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Uric Acid (n=51; n=49) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Glucose (Fasting Serum) (n=8; n=21) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Phosphorous (inorganic) (n=51; n=49) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Glucose (Serum) (n=51; n=49) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Phosphorous (inorganic) (n=51; n=49) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | Low Albumin (n=51; n=49) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid | High Glucose (Fasting Serum) (n=8; n=21) | 0 participants |
Secondary
Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study
Sodium (serum):\<0.95 \* LLN or \>1.05 \* ULN (if pre-Rx \< LLN, then \<0.95 \* pre-Rx or \>1.05 \* ULN. If pre-Rx \> ULN, then \>0.95 \* pre-Rx or \< ULN); potassium (serum):\<0.9 \* LLN or \>1.1 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN; chloride (serum),protein (total):\<0.9 \* LLN or \>1.1 8 ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>1.1 \* pre-Rx or \< LLN); calcium (total): \<0.8 \* LLN or \>1.2 \* ULN (if pre-Rx \< LLN, then \<0.9 \* pre-Rx or \> ULN. If pre-Rx \> ULN, then \>0.75 \* pre-Rx or \< ULN); phosphorous (inorganic):\<0.75 \* LLN or \>1.25 \* ULN (if pre-Rx \< ULN, then \<0.67 \* pre-Rx or \< ULN. If pre-Rx \> ULN, then \>1.33 \* re-Rx or \<LLN); glucose (serum): \<65 mg/dL or \>220 mg/dL; Glucose (fasting serum): \<0.8 \* LLN or \>1.5 ULN (if pre-Rx \<LLN, then \<2.0 \* pre-Rx or \>ULN; albumin: \<0.9 \* LLN (if pre-Rx \< LLN, then \<0.75 \* pre-Rx); uric acid: \>1.5 \* ULN (if pre-Rx \> ULN, then \>2.0 \* pre-Rx).
Time frame: Continuously from start of LTE Study up to 56 days post the last dose
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE study, were summarized. n=number of participants evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High and/or Low Sodium (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | Low Potassium (n=90) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High Potassium (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High and/or Low Chloride | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High and/or Low Total Calcium (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High and/or Low Inorganic Phosphorus (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | Low Glucose (n=90) | 21 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High Glucose (n=90) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | Low Fasting Glucose (n=28) | 3 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High Fasting Glucose (n=28) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High and/or Low Total Protein (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | Low Albumin (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study | High Uric Acid (n=90) | 1 participants |
Secondary
Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: \>2.0 \* ULN (if pre-Rx \> ULN, then \>3 \* pre-Rx); AST, ALT: \> 3 \* ULN (if pre-Rx \> ULN, then \> 4 \* pre-Rx); bilirubin (total): \>2 \* ULN, or if pre Rx \> ULN then \>4 \* Pre Rx; BUN : \>2 \* pre Rx; GGT : \>2 \* ULN, or if pre Rx \> ULN then \>3 \* pre Rx; creatinine: \>1.5 \* pre-Rx.
Time frame: Continuously from start of LTE Study up to 56 days post the last dose
Population: Participants who received at least 1 dose of abatacept in the LTE Study and with specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | High ALP (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | High AST (n=90) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | High ALT (n=90) | 3 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | High G-GT (n=90) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | High Bilirubin (n=90) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | High BUN (n=90) | 6 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study | High Creatinine (n=90) | 7 participants |
Secondary
Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: \>= 2+ (or, if value \>= 4, or if pre-Rx value = 0 or 0.5, then \>= 2x or if pre-Rx value =1, then \>= 3, or if pre-Rx = 2 or 3, then \>= 4).
Time frame: Continuously from start of LTE Study up to 56 days post the last dose
Population: Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE period, were evaluated. n=number of participants evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study | High Urine Protein (n=89) | 6 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study | High Urine Glucose (n=89) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study | High Urine Blood (n=89) | 13 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study | High Urine Esterase (n=45) | 12 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study | High Urine WBC (n=51) | 26 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study | High Urine RBC (n=47) | 16 participants |
Secondary
Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC)
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: \>= 2+ (or, if value \>= 4, or if pre-Rx value = 0 or 0.5, then \>= 2x or if pre-Rx value =1, then \>= 3, or if pre-Rx = 2 or 3, then \>= 4).
Time frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Population: All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Protein, urine (n= 51,49) | 0 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Glucose, urine (n= 51,49) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Blood, urine (n= 51,49) | 1 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Leukocyte Esterase, urine (n= 18,17) | 2 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High WBC, urine (n= 15,19) | 3 participants |
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High RBC, urine (n= 12,17) | 1 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High WBC, urine (n= 15,19) | 6 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Protein, urine (n= 51,49) | 2 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Leukocyte Esterase, urine (n= 18,17) | 3 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Glucose, urine (n= 51,49) | 0 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High RBC, urine (n= 12,17) | 7 participants |
| SC Abatacept Monotherapy Cohort | Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) | High Blood, urine (n= 51,49) | 3 participants |
Secondary
Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study
RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (\>= 15 IU/mL resulted in a positive result).
Time frame: Continuously from start of LTE period up to 7 days post the last dose
Population: Participants who received at least 1 dose of abatacept in the LTE and who had an RF test result up to 7 days post the last dose of abatacept in the LTE study, were evaluated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort | Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study | 20 participants |