Rheumatoid Arthritis (RA)
Conditions
Brief summary
The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.
Interventions
DEVICEAbatacept combination product (ACP)
Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women, ages ≥ 18 * Participants who are considered methotrexate inadequate responders (MTX-IR) * 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count) * Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period
Exclusion criteria
* Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies * Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus) * Participants with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules) * Participants with severe chronic or recurrent bacterial infections * Participants who have received treatment with rituximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Temperature Over Time in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | — |
| Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | — |
| Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | — |
| Mean Heart Rate Over Time in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | — |
| Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. |
| Number of Participants With AEs of Special Interest in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose | AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs including all infections, local injection reactions (prespecified), and systemic injection reactions (within 24 hours of dosing). |
| Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | BL=baseline; LLN lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: \>3 g/dL decrease from BL; Hematocrit: \<0.75\*BL; Erythrocytes: \<0.75\*BL; Platelets: \<0.67\*LLN/\>1.5\*ULN, or if BL \<LLN, use 0.5\*BL/\<100,000 mm\^3; Leukocytes: \<0.75\*LLN/ \>1.25\*ULN, or if BL\<LLN, use \<0.8\*BL/\>ULN, or if BL\>ULN, use \>1.2\*BL/\<LLN; neutrophils+bands: \<1.0\*10\^3 c/uL; eosinophils: \>0.750\*10\^3 c/uL; basophils: \>400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750\*10\^3 c/uL/ \>7.50\*10\^3 c/uL. |
| Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | 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 |
| Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | 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 \<LLN |
| Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose | Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. |
| Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose | An electrochemiluminescence immunoassay screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. 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 (JNCT)category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing. TRT=treatment |
| Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy | Days 1, 29, 57, 85, 169, and 253 of ACP substudy | Trough levels of abatacept were evaluated based upon serum samples. Day 1 pharmacokinetics were based on exposure to the pre-filled syringes and did not reflect abatacept exposure via the ACP device. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abatacept Combination Product (ACP) Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL). | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Participant Decision | 2 |
| Overall Study | Switch-Administrative Reason By Sponsor | 33 |
| Overall Study | Switch-Difficulty With Device | 12 |
| Overall Study | Switch-Participant Decision | 12 |
Baseline characteristics
| Characteristic | Abatacept Combination Product (ACP) |
|---|---|
| Age Continuous | 54.2 years STANDARD_DEVIATION 10.1 |
| Baseline Methotrexate Dose | 17.2 mg/wk STANDARD_DEVIATION 3.8 |
| Disease Activity Score (DAS 28) | 6.0 units on a scale STANDARD_DEVIATION 0.8 |
| Duration of Disease-Categorical >10 years | 17 participants |
| Duration of Disease-Categorical >2 - ≤5 years | 10 participants |
| Duration of Disease-Categorical ≤ 2 years | 28 participants |
| Duration of Disease-Categorical >5 - 10 years | 7 participants |
| High Sensitivity C-Reactive Protein (hs-CRP) Level | 1.7 mg/dL STANDARD_DEVIATION 1.2 |
| Mean Duration of Disease | 7.4 years STANDARD_DEVIATION 10.1 |
| Number of Swollen Joints | 20.8 swollen joints STANDARD_DEVIATION 8.2 |
| Number of Tender Joints | 31.6 tender joints STANDARD_DEVIATION 15.2 |
| Participant Global Assessment | 61.6 units on a scale STANDARD_DEVIATION 19.7 |
| Participant Pain Assessment | 64.2 units on a scale STANDARD_DEVIATION 21.5 |
| Physical Function (Health Assessment Questionnaire Disability Index [HAQ-DI]) | 1.5 units on a scale STANDARD_DEVIATION 0.7 |
| Physician Global Assessment | 62.0 units on a scale STANDARD_DEVIATION 17.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment North America | 62 participants |
| Rheumatoid Factor (RF) Status Negative | 16 participants |
| Rheumatoid Factor (RF) Status Positive | 46 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 15 Participants |
| Weight | 86.3 kg STANDARD_DEVIATION 20.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 62 |
| serious Total, serious adverse events | 2 / 62 |
Outcome results
Primary
Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept Combination Product (ACP) | Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy | Day 1 before injection (n=62) | 76.4 mm Hg | Standard Deviation 8.08 |
| Abatacept Combination Product (ACP) | Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy | Day 85 (n=50) | 78.7 mm Hg | Standard Deviation 9.99 |
| Abatacept Combination Product (ACP) | Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy | Day 169 before injection (n=42) | 75.7 mm Hg | Standard Deviation 9.31 |
| Abatacept Combination Product (ACP) | Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy | Day 253 before injection (n=15) | 78.1 mm Hg | Standard Deviation 8.29 |
| Abatacept Combination Product (ACP) | Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy | Day 365 (n=4) | 77.5 mm Hg | Standard Deviation 14.73 |
Primary
Mean Heart Rate Over Time in the ACP Device Substudy
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept Combination Product (ACP) | Mean Heart Rate Over Time in the ACP Device Substudy | Day 1 before injection (n=62) | 73.4 beats per minute | Standard Deviation 10.18 |
| Abatacept Combination Product (ACP) | Mean Heart Rate Over Time in the ACP Device Substudy | Day 85 (n=50) | 74.0 beats per minute | Standard Deviation 9.53 |
| Abatacept Combination Product (ACP) | Mean Heart Rate Over Time in the ACP Device Substudy | Day 169 before injection (n=42) | 73.4 beats per minute | Standard Deviation 9.22 |
| Abatacept Combination Product (ACP) | Mean Heart Rate Over Time in the ACP Device Substudy | Day 253 before injection (n=15) | 76.9 beats per minute | Standard Deviation 12.73 |
| Abatacept Combination Product (ACP) | Mean Heart Rate Over Time in the ACP Device Substudy | Day 365 (n=4) | 84.3 beats per minute | Standard Deviation 4.79 |
Primary
Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept Combination Product (ACP) | Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy | Day 365 (n=4) | 135.3 mm Hg | Standard Deviation 7.8 |
| Abatacept Combination Product (ACP) | Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy | Day 1 before injection (n=62) | 128.1 mm Hg | Standard Deviation 14.96 |
| Abatacept Combination Product (ACP) | Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy | Day 85 (n=50) | 130.7 mm Hg | Standard Deviation 17.08 |
| Abatacept Combination Product (ACP) | Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy | Day 169 before injection (n=42) | 128.0 mm Hg | Standard Deviation 13.61 |
| Abatacept Combination Product (ACP) | Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy | Day 253 before injection (n=15) | 127.3 mm Hg | Standard Deviation 16.63 |
Primary
Mean Temperature Over Time in the ACP Device Substudy
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept Combination Product (ACP) | Mean Temperature Over Time in the ACP Device Substudy | Day 1 before injection (n=62) | 36.6 degrees Celsius | Standard Deviation 0.39 |
| Abatacept Combination Product (ACP) | Mean Temperature Over Time in the ACP Device Substudy | Day 85 (n=50) | 36.6 degrees Celsius | Standard Deviation 0.36 |
| Abatacept Combination Product (ACP) | Mean Temperature Over Time in the ACP Device Substudy | Day 169 before injection (n=42) | 36.6 degrees Celsius | Standard Deviation 0.39 |
| Abatacept Combination Product (ACP) | Mean Temperature Over Time in the ACP Device Substudy | Day 253 before injection (n=15) | 36.6 degrees Celsius | Standard Deviation 0.27 |
| Abatacept Combination Product (ACP) | Mean Temperature Over Time in the ACP Device Substudy | Day 365 (n=4) | 36.4 degrees Celsius | Standard Deviation 0.38 |
Primary
Number of Participants With AEs of Special Interest in the ACP Device Substudy
AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs including all infections, local injection reactions (prespecified), and systemic injection reactions (within 24 hours of dosing).
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of subcutaneous abatacept administered via the ACP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With AEs of Special Interest in the ACP Device Substudy | Infections | 17 participants |
| Abatacept Combination Product (ACP) | Number of Participants With AEs of Special Interest in the ACP Device Substudy | Local injection reactions | 5 participants |
| Abatacept Combination Product (ACP) | Number of Participants With AEs of Special Interest in the ACP Device Substudy | Systemic injection reactions | 2 participants |
Primary
Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | Deaths | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | SAEs | 2 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | Treatment-related SAE | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | SAEs Leading to Discontinuation | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | AEs | 36 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | Treatment-related AEs | 11 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation | AEs Leading to Discontinuation | 0 participants |
Primary
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
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 \<LLN
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | Low Na (LLN=135 mEq/L) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | High Na (ULN=148 mEq/L) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | Low K (LLN=3.5 mEq/L) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | High K (ULN=5.5 mEq/L) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | Low Cl (LLN= 96 mEq/L) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | High Cl (ULN=109 mEq/L) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | Low Ca (LLN=8.4 mg/dL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | High Ca (ULN=10.6 mg/dL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | Low P (LLN=0.8 mg/dL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy | High P (ULN 5.6 mg/dL) | 0 participants |
Primary
Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy
BL=baseline; LLN lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: \>3 g/dL decrease from BL; Hematocrit: \<0.75\*BL; Erythrocytes: \<0.75\*BL; Platelets: \<0.67\*LLN/\>1.5\*ULN, or if BL \<LLN, use 0.5\*BL/\<100,000 mm\^3; Leukocytes: \<0.75\*LLN/ \>1.25\*ULN, or if BL\<LLN, use \<0.8\*BL/\>ULN, or if BL\>ULN, use \>1.2\*BL/\<LLN; neutrophils+bands: \<1.0\*10\^3 c/uL; eosinophils: \>0.750\*10\^3 c/uL; basophils: \>400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750\*10\^3 c/uL/ \>7.50\*10\^3 c/uL.
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | Low hemoglobin (LLN=11.5 g/dL) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | Low hematocrit (LLN=34%) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | Low erythrocytes(LLN=3.8 x10*6c/uL) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | Low platelets (LLN=140*10^9 c/L) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | High platelets (ULN=450*10^9 c/L) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | Low leukocytes (LLN= 3.8*10^3 c/uL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | High leukocytes (ULN = 10.6*10^3 c/uL) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | Low neutrophils+bands(LLN=1.8*10^3 c/uL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | High eosinophils (ULN= 7*10^3 c/uL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | High basophils (ULN= 0.2*10^3 c/uL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | High monocytes (ULN=1*10^3 c/uL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | Low lymphocytes (LLN= 0.7*10^3 c/uL) | 3 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy | High lymphocytes(ULN=4.5*10^3 c/uL) | 0 participants |
Primary
Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | High ALP (ULN=400 U/L) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | High AST (ULN=44 U/L) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | High ALT (ULN=55 U/L) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | High GGT (ULN=65 U/L) | 2 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | High bilirubin (ULN=1.2 mg/dL) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | High BUN (ULN=26 mg/dL) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy | High creatinine (ULN=1.5 mg/dL) | 1 participants |
Primary
Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
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
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | Low Glu (n=50) | 2 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High Glu (n=50) | 2 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | Low fasting Glu (LLN=65 mg/dL) (n=12) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High fasting Glu (ULN=115 mg/dL) (n=12) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | Low protein (LLN=6 g/dL) (n=50) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High protein (ULN=8.5 g/dL) (n=50) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | Low albumin (LLN=3.5 g/dL) (n=50) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High uric acid (ULN=8.7 mg/dL) (n=50) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High urine protein (normal=trace) (n=50) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High urine glucose (normal=negative) (n=50) | 2 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High urine blood (normal=negative) (n=50) | 2 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High leukocyte esterase (n=19) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High urine WBC (n=25) | 10 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy | High urine RBC (n=18) | 3 participants |
Secondary
Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy
Trough levels of abatacept were evaluated based upon serum samples. Day 1 pharmacokinetics were based on exposure to the pre-filled syringes and did not reflect abatacept exposure via the ACP device.
Time frame: Days 1, 29, 57, 85, 169, and 253 of ACP substudy
Population: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP. Trough concentrations in participants who discontinued from the substudy were not summarized descriptively, but were included in the concentration listings.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept Combination Product (ACP) | Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy | Day 1 (prior to administration with ACP) (n =53) | 24.34 ug/mL | Standard Deviation 15.56 |
| Abatacept Combination Product (ACP) | Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy | Day 29 (n=52) | 27.61 ug/mL | Standard Deviation 14.12 |
| Abatacept Combination Product (ACP) | Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy | Day 57 (n=39) | 31.52 ug/mL | Standard Deviation 14.49 |
| Abatacept Combination Product (ACP) | Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy | Day 85 (n=47) | 27.46 ug/mL | Standard Deviation 17.43 |
| Abatacept Combination Product (ACP) | Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy | Day 169 (n=35) | 26.85 ug/mL | Standard Deviation 14.55 |
| Abatacept Combination Product (ACP) | Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy | Day 253 (n=5) | 24.41 ug/mL | Standard Deviation 14.19 |
Secondary
Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy
Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose
Population: Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 29 anti-ABA (n=50) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 29 anti-CTLA4 (n=51) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 29 total (n=51) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 57 anti-ABA (n=43) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 57 anti-CTLA4 (n=43) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 57 total (n=43) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 85 anti-ABA (n=42) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 85 anti-CTLA4 (n=42) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Day 85 total (n=42) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall on-treatment visits anti-ABA (n=53) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall on-treatment visits anti-CTLA4 (n=53) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall total on-treatment visits (n=53) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | 28 days post last dose anti-ABA (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | 28 days post last dose anti-CTLA4 (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | 28 days post last dose total (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall post visits anti-ABA (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall post visits anti-CTLA4 (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall post visits total (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall anti-ABA (n=53) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall anti-CTLA4 (n=53) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy | Overall total (n=53) | 1 participants |
Secondary
Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy
An electrochemiluminescence immunoassay screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. 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 (JNCT)category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing. TRT=treatment
Time frame: ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose
Population: Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 56 days post last dose total (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 29 CTLA4 + possibly Ig (n=57) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 29 Ig and/or JNCT (n=57) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 29 total (n=57) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 57 CTLA4 + possibly Ig (n=47) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 57 Ig and/or JNCT (n=47) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 57 total (n=47) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 85 CTLA4 + possibly Ig (n=49) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 85 Ig and/or JNCT (n=49) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 85 total (n=49) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 169 CTLA4 + possibly Ig (n=43) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 169 Ig and/or JNCT (n=43) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 169 total (n=43) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 253 CTLA4 + possibly Ig (n=2) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 253 Ig and/or JNCT (n=2) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Day 253 total (n=2) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall on-TRT visits CTLA4 + possibly Ig (n=60) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall on-TRT visits Ig and/or JNCT (n=60) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall total on-TRT visits (n=60) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 28 days post last dose CTLA4 + possibly Ig (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 28 days post last dose Ig and/or JNCT (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 28 days post last dose total (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 56 days post last dose CTLA4 + possibly Ig (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 56 days post last dose Ig and/or JNCT (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 85 days post last dose CTLA4 + possibly Ig (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 85 days post last dose Ig and/or JNCT (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | 85 days post last dose total (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall post visits CTLA4 + possibly Ig (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall post visits Ig and/or JNCT (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall post visits total (n=1) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall CTLA4 + possibly Ig (n=60) | 0 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall Ig and/or JNCT (n=60) | 1 participants |
| Abatacept Combination Product (ACP) | Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy | Overall total (n=60) | 1 participants |