| Primary | Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 | Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. | Participants treated in the DBW Period with at least 1 immunogenicity result (ELISA) during DBW Period. N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Number | | percentage of participants | | Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept in DBW Period | Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | Placebo in DBW Period | Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks. |
| | | Title | Denominators | Categories |
|---|
| Anti-abatacept (n=37, n=71) | | | | Anti-CTLA4-T (n=38, n=73) | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| A continuity corrected Chi-square test was used to compare percentage of positive antibody responses of SC placebo vs. SC abatacept (Period II treatment groups) on Day 169. P-value was evaluated at 0.05 significance level (2-sided). 95% confidence interval (CI) for difference (SC PLA - SC ABA) between ABA and PLA in the immunogenicity rates was also calculated. Point estimates of the immunogenicity rates within the two Period II treatment group and the corresponding 95% CIs were also provided. | Chi-squared, Corrected | | 0.119 | There was no adjustment made for multiple comparisons. | estimate of difference | 9.59 | | | 2-Sided | 95 | 0.83 | 18.34 | | | | No | |
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| Secondary | RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group | Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. | Participants treated with Placebo in DBW period who were treated in RI period and had at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Number | | percentage of participants | | Day 253 (short term) | | | | ID | Title | Description |
|---|
| OG000 | PLA Switched to ABA With ABA IV Loading Dose in RI Period | On Day 169, participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period. | | OG001 | PLA Switched to ABA With PLA IV Loading Dose in RI Period | On Day 169, participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period. |
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| Secondary | Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time | Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. | All participants treated in LI Period who had at least 1 immunogenicity result (ELISA) during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Number | | percentage of participants | | For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug | | | | ID | Title | Description |
|---|
| OG000 | Abatacept in Lead-In Period | On Day 1, participants received a single intravenous (IV) Abatacept (ABA) dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
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| Secondary | LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time | ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative. | All participants treated in Period 1 (Lead-in Period). N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Number | | percentage of participants | | For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug | | | | ID | Title | Description |
|---|
| OG000 | Abatacept in Lead-In Period | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
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| Secondary | DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time | Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Samples were obtained during treatment (TRT) visits. | All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point. | Posted | | Number | | percentage of participants | | Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period | | | | ID | Title | Description |
|---|
| OG000 | Abatacept in DBW Period | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | Placebo in DBW Period | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Primary | Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups | Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. | Participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point. | Posted | | Number | | percentage of participants | | Day 253 (short term) | | | | ID | Title | Description |
|---|
| OG000 | ABA in DBW Period | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | Placebo in DBW Period | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits | Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. | These data were not summarized since there were no participants at any post visits. | Posted | | | | | | Day 22 after last dose of drug to Day 85 after last dose of drug | | | | ID | Title | Description |
|---|
| OG000 | ABA in DBW Period | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA in DBW Period | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time | ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative. | All participants treated in DBW period with at least 1 immunogenicity result (ECL) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Number | | percentage of participants | | Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period | | | | ID | Title | Description |
|---|
| OG000 | ABA in DBW Period | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA in DBW Period | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits | ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative. | These data were not summarized since there were no participants at any post visits | Posted | | | | | | Day 22 after last dose of drug to Day 85 after last dose of drug | | | | ID | Title | Description |
|---|
| OG000 | ABA in DBW Period | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA in DBW Period | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group | Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. | All participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point. | Posted | | Number | | percentage of participants | | For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group | ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative. | All participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Number | | percentage of participants | | For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups | Serum samples from Abatacept-treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. ST was defined as the LI Period, the DBW Period, and the RI Period (Days 1-253). | All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point. | Posted | | Number | | percentage of participants | | For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups | ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative. | All participants treated in DBW period with at least 1 immunogenicity result (ECL) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point. | Posted | | Number | | percentage of Participants | | For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups | The DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline. | Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline. | Posted | | Mean | Standard Error | units on a scale | | Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term) | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups | DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline. | Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and, when relevant, at baseline. | Posted | | Number | | percentage of participants | | Days 85, 169, and 253 (short term) | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups | The disability section of the full HAQ 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 response=an improvement of at least 0.3 units from baseline in HAQ disability Index. | Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline. | Posted | | Mean | Standard Error | units on a scale | | Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term) | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | Placebo (PLA) [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups | The disability section of the full HAQ 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 response=an improvement of at least 0.3 units from baseline in HAQ disability Index. | Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline. | Posted | | Number | | percentage of Participants | | Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term) | | | | ID | Title | Description |
|---|
| OG000 | ABA [DB] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | PLA [DB] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | LI; Mean Change in DAS 28 (CRP) From Baseline Over Time | DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline. | Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline. | Posted | | Mean | Standard Error | units on a scale | | Days 1 (Baseline), 15, 29, 57, 78, 85 | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
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| Secondary | LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time | DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline. | Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline. | Posted | | Number | | percentage of participants | | Days 15, 29, 57, 78, 85 | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
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| Secondary | DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time | DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline. | Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at DBW period baseline. | Posted | | Mean | Standard Error | units on a scale | | Days 85 (Period 2 Baseline), 113, 141, and 169 | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time | A participant had an RA flare if at least 2 of the following criteria were met:
- Doubling of tender and swollen joint count from Day 78
- Increase in DAS28-CRP score ≥ 1.2 from Day 78
- Prematurely discontinued from Double-blind Withdrawal Period (Period 2) and continued to Re-introduction Period (Period 3)
| Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point. | Posted | | Number | | percentage of participants | | Days 85, 113, 141, and 169 | | | | ID | Title | Description |
|---|
| OG000 | ABA [DB] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks | | OG001 | PLA [DB] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time | DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline. | Participants who received at least 1 dose of study medication during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at RI period baseline. | Posted | | Mean | Standard Error | units on a scale | | Days 169 (Period III Baseline), 197, 225, and 253 | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. | |
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| Secondary | LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. 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. | Participants who received at least 1 dose of study medication during LI period | Posted | | Number | | participants | | From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
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| Secondary | LI Period; Number of Participants With AEs of Special Interest | AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection) | Participants who received at least 1 dose of study medication during LI period | Posted | | Number | | participants | | From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
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| Secondary | LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria | Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/ microliter (uL); eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL. | Participants who received at least 1 dose of study medication during LI period. | Posted | | Number | | participants | | From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
| |
| Secondary | LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL | Participants who received at least 1 dose of study medication during LI period. | Posted | | Number | | participants | | From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
| |
| Secondary | LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or \ | Participants who received at least 1 dose of study medication during LI period. | Posted | | Number | | participants | | From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
| |
| Secondary | LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria | MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*upper limits of normal (ULN),or if BL< lower limits of normal (LLN) then use 0.8*BL or > upper limits of normal (ULN),or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >ULN,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis: Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells (RBCs), White Blood Cells (WBCs):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3 | Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during LI period. | Posted | | Number | | participants | | From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
| |
| Secondary | LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Blood pressure was taken in participants while seated and measured in millimeters of mercury (mmHg). Pressures were assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely. | Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period. | Posted | | Mean | Standard Deviation | mmHg | | Days 1, 15, 29, 57, 78, and 85 | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
| |
| Secondary | LI Period; Mean Heart Rate (HR) | Heart rate was taken in participants while seated and measured in beats per minute (bpm). Heart rate was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely. | Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period. | Posted | | Mean | Standard Deviation | bpm | | Days 1, 15, 29, 57, 78, and 85 | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
| |
| Secondary | LI Period; Mean Temperature (T) | Temperature was taken in participants while seated and measured in degrees celsius. Temperature was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely. | Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period. | Posted | | Mean | Standard Deviation | degrees Celsius | | Days 1, 15, 29, 57, 78, and 85 | | | | ID | Title | Description |
|---|
| OG000 | ABA [LI] | On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78. |
| |
| Secondary | DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. 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. | Participants who received at least 1 dose of study medication in DBW period | Posted | | Number | | participants | | From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | Placebo (PLA) [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW; Number of Participants With AEs of Special Interest | AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection) | Participants who received at least 1 dose of study medication in DBW period | Posted | | Number | | participants | | From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | Placebo (PLA) [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL. | Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period. | Posted | | Number | | participants | | From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL | Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period. | Posted | | Number | | participants | | From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or \ | Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period. | Posted | | Number | | participants | | From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria | MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3 | Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period. | Posted | | Number | | participants | | From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period | Blood pressures were taken in participants while seated, just prior to study drug injection, and measured in millimeters of mercury (mmHg). | Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | mm mercury (Hg) | | Days 113, 141, and 169 | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW Period; Mean Heart Rate (HR) During Period 2 | Heart Rate was taken in participants while seated, just prior to study drug injection, and measured in beats per minute (bpm) | Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Days 113, 141, and 169 | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | DBW Period; Mean Temperature (T) During Period II | Participants were seated and temperature taken just prior to study drug injection. | Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | degrees Celsius | | Days 113, 141, and 169 | | | | ID | Title | Description |
|---|
| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | PLA [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
| |
| Secondary | RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. 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. | Participants who received at least 1 dose of study medication in RI period. | Posted | | Number | | participants | | From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
|
| Secondary | RI; Number of Participants With AEs of Special Interest | AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection) | Participants who received at least 1 dose of study medication in RI period. | Posted | | Number | | participants | | From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
|
| Secondary | RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL. | Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period. | Posted | | Number | | participants | | From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
|
| Secondary | RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL | Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period. | Posted | | Number | | participants | | From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
|
| Secondary | RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria | Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or \ | Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period. | Posted | | Number | | participants | | From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
|
| Secondary | RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria | MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3 | Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period. | Posted | | Number | | participants | | From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
|
| Secondary | RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III | | Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | mm mercury (Hg) | | Days 169, 197, 225, and 253 | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. | | OG002 | PLA Switched to ABA With PLA IV Loading Dose [RI] | Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
| |
| Secondary | RI Period; Mean Heart Rate (HR) During Period III | | Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Days 169, 197, 225, and 253 | | | | ID | Title | Description |
|---|
| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. | | OG002 | PLA Switched to ABA With PLA IV Loading Dose [RI] | Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
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| Secondary | RI Period; Mean Temperature (T) During Period III | | Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | degrees Celsius | | Days 169, 197, 225, and 253 | | | | ID | Title | Description |
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| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. | | OG002 | PLA Switched to ABA With PLA IV Loading Dose [RI] | Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. |
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| Secondary | Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups | Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ELISA. | Participants treated during the RI Period with at least 1 immunogenicity result (ELISA) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Mean | Standard Deviation | ug/mL | | Day 197 through Day 253 | | | | ID | Title | Description |
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| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. | | OG002 | PLA Switched to ABA With PLA IV Loading Dose [RI] |
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| Secondary | Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups | Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ECL. | Participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Mean | Standard Deviation | ug/mL | | Day 197 through Day 253 | | | | ID | Title | Description |
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| OG000 | ABA With IV PLA Loading Dose [RI] | Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg). | | OG001 | PLA Switched to ABA With ABA IV Loading Dose [RI] | Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced. | | OG002 | PLA Switched to ABA With PLA IV Loading Dose [RI] |
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| Secondary | ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups | Venous blood was collected and tested for anti-nuclear antibodies, anti-dsDNA antibodies, and rheumatoid factor. ANA were detected by means of immunofluorescent antibodies. An anti-DNA radioimmunoassay was used for detection of anti-dsDNA antibodies (Diagnostic Products Corporation). RF was measured by an immunoturbidimetric assay (Roche Tina-Quant). Determinations of antibody or RF status were made at baseline and Day 253. | Participants treated in DBW period with at least 1 immunogenicity result (immunofluorescence, radioimmunoassay, or immunoturbidimetry) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point | Posted | | Number | | participants | | Baseline, Day 253 | | | | ID | Title | Description |
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| OG000 | ABA [DBW] | Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. | | OG001 | Placebo (PLA) [DBW] | Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks. |
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| Secondary | LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE | DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. DAS28-CRP has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169. | The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n=number of participants with both baseline and post-baseline measurements. | Posted | | Mean | Standard Error | units on a scale | | For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE | DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. Clinical remission=DAS28-CRP score<2.6. Percent=Number of participants meeting remission divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available (NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169. | The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n= number of participants evaluated at each specific timepoint | Posted | | Number | | percentage of participants | | For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821 | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE | DAS28:continuous disease measure composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. Low disease activity score: ≤ 3.2. Percent=Number of participants with Low Disease Activity divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169. | The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. | Posted | | Number | | percentage of participants | | For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE | The disability section of the full HAQ 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 (DI) was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ DI. Percent=number of participants with HAQ response divided by number of participants in the analysis. Since Period I Non-responders proceeded directly to the LTE at the end of Period I (Day 85), study days do not represent treatment days. | The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were non-responders at the end of Period 1. n= number of participants with data who were evaluated | Posted | | Number | 95% Confidence Interval | percentage of participants | | Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073 | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE | Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using electrochemiluminescence (ECL). The percent of participants with a positive abatacept induced immunogenicity response against cytotoxic T-lymphocyte antigen 4 (CTLA4) and possibly immunoglobulin (Ig), or against Ig and/or Junction Region was calculated by number of participants with a positive response divided by number of participants evaluated. Overall for on-treatment includes treatment visits on Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, and 1989. | All participants treated in LTE period with at least 1 immunogenicity result (ECL) during LTE period. n=number of participants evaluated. | Posted | | Number | | percentage of participants | | Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTE | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for All Participants | This group includes all participants who received at least one dose of 125 mg SC Abatacept during the LTE and includes both the LI Period 1 non-responder and the ST Completer cohorts. |
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| Secondary | LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE) | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. 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. SAEs include hospitalizations for elective surgical procedures.All deaths reported during the LTE including those that occurred > 56 days after the last dose. Related AE or SAE defined as AE or SAE with Certain, Probable, Possible, or Missing relationship to study medication. All participants who completed the ST period could enter the open label LTE on Day 253; LI Period 1 non-responders could directly enter the LTE. | Participants who received at least 1 dose of study medication in LTE period | Posted | | Number | | participants | | For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Number of Participants With AEs of Special Interest During LTE | AEs of special interest in LTE are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies, local injection site reaction (pre-specified AEs occurring at the site of SC injection) and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection) | Participants who received at least 1 dose of study medication in LTE period | Posted | | Number | | participants | | For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. | | OG001 | LTE Abatacept for Short Term Completers |
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| Secondary | LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE | Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL. | Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period. | Posted | | Number | | participants | | For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE | Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL | Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period. | Posted | | Number | | participants | | For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. | |
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| Secondary | LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE | Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or \ | Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period. | Posted | | Number | | participants | | For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE | MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3 | Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the LTE period. | Posted | | Number | | participants | | For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. |
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| Secondary | LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE | During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely. | Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | mm Hg | | Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073 | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. | | OG001 | LTE Abatacept for Short Term Completers | |
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| Secondary | LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE | During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely. | Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | mmHg | | Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073 | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. | | OG001 | LTE Abatacept for Short Term Completers | |
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| Secondary | LTE: Mean Heart Rate (HR) During LTE | During LTE, heart rate was taken in participants while seated, measured in beats per minute (bpm) and was assessed at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely. | Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | bpm | | Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073 | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. | | OG001 | LTE Abatacept for Short Term Completers | Participant's who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate). |
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| Secondary | LTE: Mean Temperature (T) During LTE | During LTE, temperature was taken in participants while seated, measured in degrees celsius and was assessed at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely. | Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point. | Posted | | Mean | Standard Deviation | degrees Celsius | | Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073 | | | | ID | Title | Description |
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| OG000 | LTE Abatacept for LI Period 1 Non-responders | Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study. | | OG001 | LTE Abatacept for Short Term Completers | Participant's who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate). |
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