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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT # 2007-005434-37 |
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The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous (SC) Abatacept | Active Comparator | Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. |
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| Intravenous (IV) Abatacept | Active Comparator | Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous (SC) Abatacept | Drug | Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 | The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). | Day 169 |
| Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population | Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized. | Days 85, and 169 and postvisits on Days 28, 56, and 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures. |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Associates, Pc | Birmingham | Alabama | 35205 | United States | ||
| Coastal Clinical Research, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27229685 | Derived | Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z. | |
| 24584926 | Derived | Genovese MC, Tena CP, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Delaet I, Teng J, Alten R. Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol. 2014 Apr;41(4):629-39. doi: 10.3899/jrheum.130112. Epub 2014 Mar 1. |
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2492 enrolled: 2472 in Main Study:1008 not randomized: 918 no longer met criteria, 61 withdrew consent, 7 lost to follow-up, 22 other reasons. Randomized, not treated: 4 no longer met criteria, 2 withdrew consent, and 1 randomization error; 20 enrolled in Anti-TNF sub-study; 2 not randomized as no longer met criteria; 18 randomized in substudy.
During the double blind short term (ST) period of the Main study, a sub-study in RA participants was initiated to evaluate anti-tumor necrosis factor (TNF) failure population. The sub-study was terminated early due to slow recruitment and participants from the sub-study were allowed to roll into the Main study during the LT Open Label Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subcutaneous (SC) Abatacept | During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. During the Open Label Long Term (LT) Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind ST Period Main Study |
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| Intravenous (IV) Abatacept | Drug | Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). 500mg (for body weight up to 60 kg) 750 mg (body weight between 61 and 100 kg) 1g (body weight above 100 kg)infusions |
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| Day 169 |
| Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 | The disability section of the full HAQ-DI includes 20 questions to assess physical functions 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=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. | Day 169 |
| Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. | Baseline to Day 169 |
| Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169 | The disability section of the full HAQ-DI includes 20 questions to assess physical functions 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=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI. | Day 169 |
| Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation | AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. |
| Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died | AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. |
| Double-blind Period: Number of Participants With AEs of Special Interest | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions | Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first. |
| Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements | Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator. | Day 1 through end of short-term period (Day 169) |
| Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality | ULN=upper limit of normal; LLN=lower limit of normal; BL= baseline. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; hematocrit: <0.75*BL; erythrocytes: <0.75*BL; platelets: <0.67*LLN/>1.5*ULN, or if BL<LLN, use <0.5*BL and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL. | Day 1 through end of short-term period (Day 169) |
| Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality | Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN, use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-glutamyl transferase (GGT): >2* ULN, or if BL>ULN, use >3*BL; bilirubin: >2* ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2* BL; creatinine: >1.5*BL | Day 1 through end of short-term period (Day 169) |
| Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality | Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or \ | Day 1 through end of short-term period (Day 169) |
| Double-blind Period: Minimum Observed Serum Concentration of Abatacept | Days 57, 85, 113, 120, 127, 134, 141, and 169 |
| Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept | Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. | Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period) |
| Double-blind Period: Maximum Observed Serum Concentration of Abatacept | End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous |
| Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept | Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL). | End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous |
| Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept | Dosing interval between Days 113 and 141 (TAU=28 days) |
| Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept | Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141. | Dosing Interval between Days 113 and 141 (TAU=28 days) |
| Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA) | Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4). | Days 85, and 169 and postvisits on Days 28, 56, and 85 |
| Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period | C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit. | Baseline to Days 15, 29, 57, 85, 113, 141, and 169 |
| Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized | An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment. | Days 85, and 169 and postvisits on Days 28, 56, and 85 |
| Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline | Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. | Baseline to Day 169 |
| Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821 | The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). | Days 169, 729, 1261, 1821 |
| Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821 | The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures. | Days 169, 729, 1261, 1821 |
| Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821 | The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline. | Days 169, 729, 1261, 1821 |
| Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821 | The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. | Days 169, 729, 1261, 1821 |
| Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821 | The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. | Days 169, 729, 1261, 1821 |
| Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821 | The disability section of the full HAQ includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score. | Days 169, 729, 1261, 1821 |
| Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation | AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug | End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014) |
| Open-Label LT Period: Number of Participants With AEs of Special Interest | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions. | End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014) |
| Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements | Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator. | End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014) |
| Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities | Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator. | End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014) |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Advanced Arthritis Care & Research | Scottsdale | Arizona | 85258 | United States |
| Catalina Pointe Clinical Research, Inc. | Tucson | Arizona | 85704 | United States |
| St. Joseph'S Mercy Clinic | Hot Springs | Arkansas | 71913 | United States |
| Talbert Medical Group | Huntington Beach | California | 92646 | United States |
| Allergy & Rheumatology Medical Clinic, Inc. | La Jolla | California | 92037 | United States |
| Valerius Medical Group &Research Ctr. Of Greater Long Beach | Long Beach | California | 90806 | United States |
| Stanford University School Of Medicine | Palo Alto | California | 94304 | United States |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | United States |
| Boulder Medical Center | Boulder | Colorado | 80304 | United States |
| Arthritis Assoc And Osteo Ctr Of Col Sprgs | Colorado Springs | Colorado | 80910 | United States |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | United States |
| Arthritis Center Of The Rockies, Pc | Loveland | Colorado | 80538 | United States |
| Guadagnoli, Germano | Bridgeport | Connecticut | 06606 | United States |
| Joao Nascimento | Bridgeport | Connecticut | 06606 | United States |
| Clinical Research Center Of Ct/Ny | Danbury | Connecticut | 06810 | United States |
| Arthritis And Rheumatic Disease Specialties | Aventura | Florida | 33180 | United States |
| Arthritis & Osteoporosis Treatment Center, Pa | Orange Park | Florida | 32073 | United States |
| Rheumatology Associates Of Central Florida | Orlando | Florida | 32806 | United States |
| The Arthritis Center | Palm Harbor | Florida | 34684 | United States |
| Sarasota Arthritis Research Center | Sarasota | Florida | 34239 | United States |
| Arthritis & Rheumatology Of Georgia,Pc | Atlanta | Georgia | 30342 | United States |
| Boise Rheumatology/ Intermountain Research Center, Inc | Boise | Idaho | 83702 | United States |
| Coeur D'Alene Arthrit Clin | Coeur d'Alene | Idaho | 83814 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Rockford Orthopedic Associates, Ltd. | Rockford | Illinois | 61107 | United States |
| The Arthritis Center | Springfield | Illinois | 62704 | United States |
| Klein And Associates, M.D., Pa | Cumberland | Maryland | 21502 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Shores Rheumatology, P. C. | Saint Clair Shores | Michigan | 48081 | United States |
| Arthritis Assoicates Of Mississippi | Jackson | Mississippi | 39202 | United States |
| Kansas City Internal Medicine | Lee's Summit | Missouri | 64086 | United States |
| Physician Research Collaboration, Llc | Lincoln | Nebraska | 68516 | United States |
| Allergy And Arthritis Associates | Dover | New Jersey | 07801 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Albuquerque Rehabilitation & Rheumatology Pc | Albuquerque | New Mexico | 87102 | United States |
| The Center For Rheumatology, Llp | Albany | New York | 12206 | United States |
| Southern Tier Arthritis & Rheumatism | Olean | New York | 14760 | United States |
| Arthritis Health Associates | Syracuse | New York | 13210 | United States |
| Asheville Rheumatology & Osteoporosis Research Asso P. A. | Asheville | North Carolina | 28801 | United States |
| The Arthritis Clinic & Carolina Bone & Joint | Charlotte | North Carolina | 28210 | United States |
| Rheumatology | Durham | North Carolina | 27704 | United States |
| Physicians East, Pa | Greenville | North Carolina | 27834 | United States |
| Carolina Pharmaceutical Research | Statesville | North Carolina | 28625 | United States |
| Carolina Arthritis Associates | Wilmington | North Carolina | 28401 | United States |
| Cincinnati Rheumatic Disease Study Group | Cincinnati | Ohio | 45219 | United States |
| Health Research Of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| Oklahoma Center For Arthritis Therapy And Research | Tulsa | Oklahoma | 74104 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| Pro Research | Eugene | Oregon | 97401 | United States |
| Portland Rheumatology Clinic, Llc | Lake Oswego | Oregon | 97035 | United States |
| East Penn Rheumatology Associates | Bethlehem | Pennsylvania | 18015 | United States |
| Rheumatology Associates | Providence | Rhode Island | 02906 | United States |
| Low Country Rheumatology, Pa | Charleston | South Carolina | 29406 | United States |
| Columbia Arthritis Center | Columbia | South Carolina | 29204 | United States |
| Carolina Health Specialists | Myrtle Beach | South Carolina | 29572 | United States |
| Acme Research, Llc | Orangeburg | South Carolina | 29118 | United States |
| Arthritis Clinic | Jackson | Tennessee | 38305 | United States |
| Rheumatology Consultants Pllc | Knoxville | Tennessee | 37909 | United States |
| The Arthritis Group, Pc | Memphis | Tennessee | 38104 | United States |
| St. Thomas Hospital Tower East | Nashville | Tennessee | 37205 | United States |
| Walter F. Chase | Austin | Texas | 78705 | United States |
| Rheumatic Disease Clinical Research Center, Llc | Houston | Texas | 77004 | United States |
| Accurate Clinical Research | Houston | Texas | 77034 | United States |
| Texas Research Center | Sugarland | Texas | 77479 | United States |
| Arthritis Clinic Of Northern Virginia, P.C. | Arlington | Virginia | 22205 | United States |
| Center For Arthritis & Rheumatic Diseases, Pc | Chesapeake | Virginia | 23320 | United States |
| South Puget Sound Clinincal Research Center | Olympia | Washington | 98502 | United States |
| Tacoma Center For Arthritis Research Ps | Tacoma | Washington | 98405 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1015 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | 1426 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | C1428DQG | Argentina |
| Local Institution | Ciudad Autonoma | Buenos Aires | CP1425A WC | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5016 | Argentina |
| Local Institution | Rosario, Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Santa Fe | Santa Fe Province | 3000 | Argentina |
| Local Institution | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Local Institution | St Leonards | New South Wales | 2065 | Australia |
| Local Institution | Cairns | Queensland | QLD 4870 | Australia |
| Local Institution | Maroochydore | Queensland | 4558 | Australia |
| Local Institution | Woodville | South Australia | 5011 | Australia |
| Local Institution | Heidelberg | Victoria | 3081 | Australia |
| Local Institution | Shenton Park | Western Australia | 6008 | Australia |
| Local Institution | Brussels | 1020 | Belgium |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Hasselt | 3500 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Wilrijk | 2610 | Belgium |
| Local Institution | Yvoir | 5530 | Belgium |
| Local Institution | Goiânia | Goiás | 74110 | Brazil |
| Local Institution | Goiânia | Goiás | 74605 | Brazil |
| Local Institution | Juiz de Fora | Minas Gerais | 36010 | Brazil |
| Local Institution | Curitiba | Paraná | 80060240 | Brazil |
| Local Institution | Curitiba | Paraná | 80440 | Brazil |
| Local Institution | Recife | Pernambuco | 50670 | Brazil |
| Local Institution | Rio de Janeiro | Rio de Janeiro | 20551 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035003 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 91610 | Brazil |
| Local Institution | Campinas | São Paulo | 13059 | Brazil |
| Local Institution | Campinas | São Paulo | 13083 | Brazil |
| Local Institution | São Paulo | São Paulo | 04027 | Brazil |
| Local Institution | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Local Institution | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Local Institution | Hamilton | Ontario | L8N 1Y2 | Canada |
| Local Institution | Hamilton | Ontario | L8N 2B6 | Canada |
| Local Institution | Mississauga | Ontario | L5M 2V8 | Canada |
| Local Institution | Ottawa | Ontario | K1H 1A2 | Canada |
| Local Institution | Ste-Foy | Quebec | G1V 3M7 | Canada |
| Local Institution | Ste-Foy | Quebec | G1W 4R4 | Canada |
| Local Institution | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Local Institution | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Local Institution | Santiago | Santiago Metropolitan | 0 | Chile |
| Local Institution | Santiago | Santiago Metropolitan | 7500995 | Chile |
| Local Institution | Santiago | Santiago Metropolitan | Chile |
| Local Institution | Bordeaux | 33076 | France |
| Local Institution | Brest | 29609 | France |
| Local Institution | Chambray-lès-Tours | 37170 | France |
| Local Institution | Le Mans | 72037 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Marseille | 13008 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Poitiers | 86021 | France |
| Local Institution | Strasbourg | 67098 | France |
| Local Institution | Berlin | 14059 | Germany |
| Local Institution | Leipzig | 04103 | Germany |
| Local Institution | München | 80639 | Germany |
| Local Institution | München | 81541 | Germany |
| Local Institution | Heraklion Crete | 71110 | Greece |
| Local Institution | Budapest | 1023 | Hungary |
| Local Institution | Debrecen | 4012 | Hungary |
| Local Institution | Secunderabad | Andhra Pradesh | 500003 | India |
| Local Institution | Navrangpura, Ahmedabad | Gujarat | 380009 | India |
| Local Institution | Bangalore | Karnataka | 560 034 | India |
| Local Institution | Bangalore | 560003 | India |
| Local Institution | Hyderabad | 500004 | India |
| Local Institution | Lucknow | 226014 | India |
| Local Institution | New Delhi | 110029 | India |
| Local Institution | Dublin | Dublin | 4 | Ireland |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Pavia | 27100 | Italy |
| Local Institution | Roma | 00168 | Italy |
| Local Institution | Siena | 53100 | Italy |
| Local Institution | Aguascalientes | Aguascalientes | 20230 | Mexico |
| Local Institution | Chihuahua City | Chihuahua | 31000 | Mexico |
| Local Institution | Tijuana | Estado de Baja California | 22320 | Mexico |
| Local Institution | Guadalajara | Jalisco | 0 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44100 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44620 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44690 | Mexico |
| Local Institution | Mexico City | Mexico City | 06726 | Mexico |
| Local Institution | Morelia | Michioacan | 58270 | Mexico |
| Local Institution | Nuevo León | Nuevo León | 64020 | Mexico |
| Local Institution | Querétaro City | Querétaro | 76178 | Mexico |
| Local Institution | San Luis Potosà City | San Luis Potosà | 78240 | Mexico |
| Local Institution | Mérida | Yucatán | 97000 | Mexico |
| Local Institution | Leeuwarden | 8934 AD | Netherlands |
| Local Institution | Lima | Lima Province | 11 | Peru |
| Local Institution | Lima | Lima Province | LIMA 13 | Peru |
| Local Institution | Lima | Lima Province | LIMA 27 | Peru |
| Local Institution | Lima | Lima Province | LIMA 33 | Peru |
| Local Institution | Callao | Provincia Constitucional del Callao | CALLAO 2 | Peru |
| Local Institution | Bialystok | 15-337 | Poland |
| Local Institution | Bialystok | 15-461 | Poland |
| Local Institution | Bydgoszcz | 85-168 | Poland |
| Local Institution | Gmina Końskie | 26-200 | Poland |
| Local Institution | Krakow | 30-510 | Poland |
| Local Institution | Poznan | 60-218 | Poland |
| Local Institution | Poznan | 60773 | Poland |
| Local Institution | Torun | 87-100 | Poland |
| Local Institution | Warsaw | 02-777 | Poland |
| Local Institution | Moscow | 115522 | Russia |
| Local Institution | Moscow | 119049 | Russia |
| Local Institution | Moscow | 129327 | Russia |
| Local Institution | Yaroslavl | 150003 | Russia |
| Local Institution | Yekaterinburg | 620102 | Russia |
| Local Institution | Kempton Park | Gauteng | 1619 | South Africa |
| Local Institution | Muckleneuk | Gauteng | 0002 | South Africa |
| Local Institution | Muckleneuk | Gauteng | 0132 | South Africa |
| Local Institution | Pretoria | Gauteng | 0083 | South Africa |
| Local Institution | Durban | KwaZulu-Natal | 4001 | South Africa |
| Local Institution | Panorama | Western Cape | 7500 | South Africa |
| Local Institution | Seoul | Sungdong-Gu | 133-792 | South Korea |
| Local Institution | Daegu | 705-718 | South Korea |
| Local Institution | Daejeon | 302-799 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 137-040 | South Korea |
| Local Institution | Kaohsiung City | 833 | Taiwan |
| Local Institution | Taichung | 402 | Taiwan |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Taichung | 407 | Taiwan |
| Local Institution | Denizli | 20070 | Turkey (Türkiye) |
| Local Institution | Edirne | 22030 | Turkey (Türkiye) |
| Local Institution | Gaziantep | 27310 | Turkey (Türkiye) |
| Local Institution | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
| Local Institution | Bridgend | Glamorgan | CF31 1RQ | United Kingdom |
| Local Institution | London | Greater London | E11 1NR | United Kingdom |
| Local Institution | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Local Institution | Newcastle upon Tyne | Tyne and Wear | NE7 7DN | United Kingdom |
| 21618201 | Derived | Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463. |
| FG001 | Intravenous (IV) Abatacept | During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Anti-TNF Sub-Study in ST Period |
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|
| Open Label LT Period Main + Sub-Study |
|
|
Per-protocol Population in ST Period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subcutaneous (SC) Abatacept | Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies. |
| BG001 | Intravenous (IV) Abatacept | Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Since regulatory guidelines indicate use of the Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) for non-inferiority studies, this population was used to perform primary and key secondary efficacy analyses. Thus, Baseline continuous age data are presented for the PP Analysis Population. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region Of Enrollment | Number | participants |
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| Baseline Weight Category | Number | participants |
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| Duration of RA Disease | Mean | Standard Deviation | years |
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| Duration of Disease Category | Number | participants |
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| Number of Tender Joints | Tender joints are an indicator of Rheumatoid Arthritis. The number of tender joints in a standard 68 joint count was evaluated. The number of tender joints ranges from 0 tender joints to 68, where an increased number of tender joints indicates increasing level of disease severity. | Mean | Standard Deviation | tender joints |
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| Number of Swollen Joints | Swollen joints are an indicator of Rheumatoid Arthritis. The number of swollen joints in a standard 66 joint count was evaluated. The number of swollen joints ranges from 0 swollen joints to 66, where an increased number of swollen joints indicates increasing level of disease severity. | Mean | Standard Deviation | swollen joints |
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| Participant Pain Assessment | The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit. | Mean | Standard Deviation | units on a scale |
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| Physical Function (Health Assessment Questionnaire Disability Index [HAQ-DI]) | The disability section of the full HAQ includes 20 questions to assess physical The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. | Mean | Standard Deviation | units on a scale |
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| Participant Global Assessment | Participants used a horizontal VAS of 100 mm for overall assessment of rheumatoid arthritis. Scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical through a horizontal line to indicate state of rheumatoid arthritis. Distance from the "very well" end of the horizontal line to the vertical line drawn by the participant was the global disease assessment score on a scale of 1-10, where 1=controlled or equivocal rheumatoid arthritis activity, 1.1-4=mild activity, 4-8=moderate activity, and 8.1-10=high activity. | Mean | Standard Deviation | units on a scale |
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| Physician Global Assessment | Physician global rheumatoid arthritis assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the most pain possible. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| High Sensitivity C-Reactive Protein (hsCRP) Level | hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. | Mean | Standard Deviation | mg/dL |
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| Disease Activity Score (CRP) | The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. | Mean | Standard Deviation | units on a scale |
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| Rheumatoid Factor Status | Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL. | Number | participants |
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| Baseline Methotrexate (MTX) Dose | Mean | Standard Deviation | mg/wk |
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| Weight | Mean | Standard Deviation | kg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 | The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). | Per protocol (PP) population, defined as participants who are compliant with the study criteria. | Posted | Number | participants | Day 169 |
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| Secondary | Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures. | PP population, defined as participants who are compliant with the study criteria. | Posted | Number | participants | Day 169 |
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| Secondary | Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 | The disability section of the full HAQ-DI includes 20 questions to assess physical functions 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=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. | All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available. | Posted | Mean | Standard Deviation | units on a scale | Day 169 |
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| Secondary | Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. | All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available. | Posted | Mean | Standard Error | units on a scale | Baseline to Day 169 |
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| Secondary | Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169 | The disability section of the full HAQ-DI includes 20 questions to assess physical functions 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=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI. | All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available | Posted | Number | participants | Day 169 |
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| Secondary | Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation | AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug | All randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. |
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| Secondary | Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died | AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. | All randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. |
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| Secondary | Double-blind Period: Number of Participants With AEs of Special Interest | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions | All randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first. |
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| Secondary | Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements | Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator. | All randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Day 1 through end of short-term period (Day 169) |
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| Secondary | Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality | ULN=upper limit of normal; LLN=lower limit of normal; BL= baseline. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; hematocrit: <0.75*BL; erythrocytes: <0.75*BL; platelets: <0.67*LLN/>1.5*ULN, or if BL<LLN, use <0.5*BL and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL. | All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available. | Posted | Number | participants | Day 1 through end of short-term period (Day 169) |
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| Secondary | Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality | Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN, use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-glutamyl transferase (GGT): >2* ULN, or if BL>ULN, use >3*BL; bilirubin: >2* ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2* BL; creatinine: >1.5*BL | All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available. | Posted | Number | participants | Day 1 through end of short-term period (Day 169) |
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| Secondary | Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality | Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or \ | All randomized participants who received at least 1 dose of study medication. N=number of participants with assessments available. | Posted | Number | participants | Day 1 through end of short-term period (Day 169) |
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| Secondary | Double-blind Period: Minimum Observed Serum Concentration of Abatacept | Participants who received at least 1 dose of study medication and from whom at least 1 pharmacokinetic (PK) sample was collected and reported (N). Only participants with adequate PK profiles were included in the summary statistics and statistical analysis (n). | Posted | Geometric Mean | Standard Deviation | µg/mL | Days 57, 85, 113, 120, 127, 134, 141, and 169 |
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| Secondary | Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept | Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. | Participants who received at least 1 dose of study medication and who had adequate PK profiles were analyzed. n= number of participants available at each specific time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period) |
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| Secondary | Double-blind Period: Maximum Observed Serum Concentration of Abatacept | Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis | Posted | Geometric Mean | Standard Deviation | µg/mL | End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous |
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| Secondary | Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept | Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL). | Participants in the Sub-study who received at least 1 dose of study medication and who had adequate PK profiles were analyzed | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous |
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| Secondary | Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept | Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis | Posted | Geometric Mean | Standard Deviation | µg*h/mL | Dosing interval between Days 113 and 141 (TAU=28 days) |
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| Secondary | Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept | Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141. | Participants in the sub-study who received at least 1 dose of study medication and who had adequate PK profiles for analysis | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | Dosing Interval between Days 113 and 141 (TAU=28 days) |
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| Secondary | Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA) | Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4). | All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available. | Posted | Number | participants | Days 85, and 169 and postvisits on Days 28, 56, and 85 |
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| Secondary | Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period | C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit. | All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available. | Posted | Median | Inter-Quartile Range | percent change | Baseline to Days 15, 29, 57, 85, 113, 141, and 169 |
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| Secondary | Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized | An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment. | All participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result reported during the short-term period. | Posted | Number | participants | Days 85, and 169 and postvisits on Days 28, 56, and 85 |
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| Secondary | Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline | Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. | All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available. | Posted | Number | participants | Baseline to Day 169 |
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| Secondary | Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821 | The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). | All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized. | Posted | Number | participants | Days 169, 729, 1261, 1821 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821 | The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures. | All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized. | Posted | Number | participants | Days 169, 729, 1261, 1821 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821 | The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline. | All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized. | Posted | Mean | 95% Confidence Interval | units on a scale | Days 169, 729, 1261, 1821 |
|
| |||||||||||||||||||||||||||||
| Secondary | Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821 | The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. | All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized. | Posted | Number | participants | Days 169, 729, 1261, 1821 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821 | The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. | All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized. | Posted | Number | participants | Days 169, 729, 1261, 1821 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821 | The disability section of the full HAQ includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score. | All participants who entered the LT period, received at least 1 dose of study drug during the LT period, and had HAD-QI scores at baseline and at specified days were summarized. | Posted | Number | participants | Days 169, 729, 1261, 1821 |
|
| ||||||||||||||||||||||||||||||
| Primary | Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population | Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized. | All randomized participants in the Anti-TNF Failure Sub-study who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available. | Posted | Number | participants | Days 85, and 169 and postvisits on Days 28, 56, and 85 |
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| Secondary | Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation | AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug | All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period. | Posted | Number | participants | End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014) |
| |||||||||||||||||||||||||||||||
| Secondary | Open-Label LT Period: Number of Participants With AEs of Special Interest | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions. | All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period. | Posted | Number | participants | End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014) |
|
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| Secondary | Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements | Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator. | All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period. | Posted | Number | participants | End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014) |
|
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| Secondary | Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities | Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator. | All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period. | Posted | Number | participants | End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014) |
|
|
First dose (Day 1) in ST period to last dose in LT period plus 85 days, up to 5 years (September 2014).
Population includes both Main Study and Anti-TNF Failure Sub-study. Sub-study was terminated early and participants could enter LT Period of Main study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Abatacept | During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could switch to SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. | 206 | 731 | 544 | 731 | ||
| EG001 | SC Abatacept | During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could continue SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. | 199 | 744 | 567 | 744 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Brain stem stroke | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Infective tenosynovitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatic cyst | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Basilar migraine | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Jaundice hepatocellular | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peritoneal tuberculosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary bulla | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Adhesion | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Enterococcus test positive | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Median nerve injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Quadriparesis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Embedded device | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Ludwig angina | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Necrotising granulomatous lymphadenitis | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Viral hepatitis carrier | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia haemorrhagic | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Metatarsus primus varus | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mucoepidermoid carcinoma of salivary gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Ovarian mass | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Skin wrinkling | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Biliary cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Device failure | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Retinal infarction | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Adenosquamous cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Enterocele | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Pacemaker generated arrhythmia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Radiculitis lumbosacral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac function disturbance postoperative | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Cervical cord compression | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gallbladder cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mammoplasty | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tetanus | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
Not provided
Not provided
| Pregnancy |
|
| Lost to Follow-up |
|
| Administrative reason by Sponsor |
|
| Death |
|
| No longer met criteria |
|
| Lack of Efficacy |
|
| Poor/non-compliance |
|
| non-specified |
|
| no end of study status page |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| South America |
|
| Europe |
|
| Rest of the World |
|
| 60 to 100 kg |
|
| >100 kg |
|
| 2 - ≤5 yrs |
|
| 5 - ≤10 yrs |
|
| > 10 yrs |
|
| Positive |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|
|
During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. |
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| Participants |
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| Participants |
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Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
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| Counts |
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