Trial Outcomes & Findings for Methotrexate - Inadequate Response Device Sub-Study (NCT NCT01173120)
NCT ID: NCT01173120
Last Updated: 2012-01-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
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.
Results posted on
2012-01-12
Participant Flow
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
|
62
|
|
Overall Study
Switched Back to Main Study
|
57
|
|
Overall Study
Discontinued ACP Substudy and Main Study
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
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).
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|---|---|
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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-Participant Decision
|
12
|
|
Overall Study
Switch-Difficulty With Device
|
12
|
Baseline Characteristics
Methotrexate - Inadequate Response Device Sub-Study
Baseline characteristics by cohort
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
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).
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|---|---|
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Age Continuous
|
54.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
62 participants
n=5 Participants
|
|
Weight
|
86.3 kg
STANDARD_DEVIATION 20.1 • n=5 Participants
|
|
Mean Duration of Disease
|
7.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Duration of Disease-Categorical
≤ 2 years
|
28 participants
n=5 Participants
|
|
Duration of Disease-Categorical
>2 - ≤5 years
|
10 participants
n=5 Participants
|
|
Duration of Disease-Categorical
>5 - 10 years
|
7 participants
n=5 Participants
|
|
Duration of Disease-Categorical
>10 years
|
17 participants
n=5 Participants
|
|
Number of Tender Joints
|
31.6 tender joints
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Number of Swollen Joints
|
20.8 swollen joints
STANDARD_DEVIATION 8.2 • n=5 Participants
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|
Participant Pain Assessment
|
64.2 units on a scale
STANDARD_DEVIATION 21.5 • n=5 Participants
|
|
Physical Function (Health Assessment Questionnaire Disability Index [HAQ-DI])
|
1.5 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Participant Global Assessment
|
61.6 units on a scale
STANDARD_DEVIATION 19.7 • n=5 Participants
|
|
Physician Global Assessment
|
62.0 units on a scale
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
High Sensitivity C-Reactive Protein (hs-CRP) Level
|
1.7 mg/dL
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Disease Activity Score (DAS 28)
|
6.0 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Rheumatoid Factor (RF) Status
Positive
|
46 participants
n=5 Participants
|
|
Rheumatoid Factor (RF) Status
Negative
|
16 participants
n=5 Participants
|
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Baseline Methotrexate Dose
|
17.2 mg/wk
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 monthsPopulation: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.
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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
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|---|---|
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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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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 dosePopulation: As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of subcutaneous abatacept administered via the ACP.
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).
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
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|---|---|
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Number of Participants With AEs of Special Interest in the ACP Device Substudy
Infections
|
17 participants
|
|
Number of Participants With AEs of Special Interest in the ACP Device Substudy
Local injection reactions
|
5 participants
|
|
Number of Participants With AEs of Special Interest in the ACP Device Substudy
Systemic injection reactions
|
2 participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=50 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
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|---|---|
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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
|
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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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=50 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
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|---|---|
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Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
High ALP (ULN=400 U/L)
|
0 participants
|
|
Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
High AST (ULN=44 U/L)
|
1 participants
|
|
Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
High ALT (ULN=55 U/L)
|
1 participants
|
|
Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
High GGT (ULN=65 U/L)
|
2 participants
|
|
Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
High bilirubin (ULN=1.2 mg/dL)
|
0 participants
|
|
Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
High BUN (ULN=26 mg/dL)
|
1 participants
|
|
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 outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=50 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
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|---|---|
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Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
Low Na (LLN=135 mEq/L)
|
0 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
High Na (ULN=148 mEq/L)
|
0 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
Low K (LLN=3.5 mEq/L)
|
1 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
High K (ULN=5.5 mEq/L)
|
1 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
Low Cl (LLN= 96 mEq/L)
|
0 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
High Cl (ULN=109 mEq/L)
|
0 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
Low Ca (LLN=8.4 mg/dL)
|
0 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
High Ca (ULN=10.6 mg/dL)
|
0 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
Low P (LLN=0.8 mg/dL)
|
0 participants
|
|
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
High P (ULN 5.6 mg/dL)
|
0 participants
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=50 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
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|---|---|
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Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
High urine RBC (n=18)
|
3 participants
|
|
Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
Low Glu (n=50)
|
2 participants
|
|
Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
High Glu (n=50)
|
2 participants
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
High leukocyte esterase (n=19)
|
1 participants
|
|
Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
High urine WBC (n=25)
|
10 participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
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|---|---|
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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
|
|
Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy
Day 85 (n=50)
|
130.7 mm Hg
Standard Deviation 17.08
|
|
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
|
|
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
|
|
Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy
Day 365 (n=4)
|
135.3 mm Hg
Standard Deviation 7.80
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
|
|---|---|
|
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
|
|
Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy
Day 85 (n=50)
|
78.7 mm Hg
Standard Deviation 9.99
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
|
|---|---|
|
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
|
|
Mean Heart Rate Over Time in the ACP Device Substudy
Day 85 (n=50)
|
74.0 beats per minute
Standard Deviation 9.53
|
|
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
|
|
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
|
|
Mean Heart Rate Over Time in the ACP Device Substudy
Day 365 (n=4)
|
84.3 beats per minute
Standard Deviation 4.79
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
|
|---|---|
|
Mean Temperature Over Time in the ACP Device Substudy
Day 1 before injection (n=62)
|
36.6 degrees Celsius
Standard Deviation 0.39
|
|
Mean Temperature Over Time in the ACP Device Substudy
Day 85 (n=50)
|
36.6 degrees Celsius
Standard Deviation 0.36
|
|
Mean Temperature Over Time in the ACP Device Substudy
Day 169 before injection (n=42)
|
36.6 degrees Celsius
Standard Deviation 0.39
|
|
Mean Temperature Over Time in the ACP Device Substudy
Day 253 before injection (n=15)
|
36.6 degrees Celsius
Standard Deviation 0.27
|
|
Mean Temperature Over Time in the ACP Device Substudy
Day 365 (n=4)
|
36.4 degrees Celsius
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Days 1, 29, 57, 85, 169, and 253 of ACP substudyPopulation: 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.
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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=62 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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 dosePopulation: 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.
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.
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=53 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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 dosePopulation: 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.
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
Outcome measures
| Measure |
Abatacept Combination Product (ACP)
n=60 Participants
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy
Overall total (n=60)
|
1 participants
|
Adverse Events
Abatacept Combination Product (ACP)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abatacept Combination Product (ACP)
n=62 participants at risk
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).
|
|---|---|
|
General disorders
Chest Pain
|
1.6%
1/62 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.6%
1/62 • Number of events 1
|
Other adverse events
| Measure |
Abatacept Combination Product (ACP)
n=62 participants at risk
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).
|
|---|---|
|
Infections and infestations
Bronchitis
|
6.5%
4/62 • Number of events 4
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.5%
4/62 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER