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Trial record 27 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Methotrexate - Inadequate Response Device Sub-Study (MTX-IR)

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ClinicalTrials.gov Identifier: NCT01173120
Recruitment Status : Completed
First Posted : July 30, 2010
Results First Posted : July 6, 2011
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis (RA)
Intervention Device: Abatacept combination product (ACP)
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 62
Switched Back to Main Study 57
Discontinued ACP Substudy and Main Study 5
Completed 0
Not Completed 62
Reason Not Completed
Lack of Efficacy             2
Lost to Follow-up             1
Participant Decision             2
Switch-Administrative Reason By Sponsor             33
Switch-Participant Decision             12
Switch-Difficulty With Device             12
Arm/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
54.2  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
47
  75.8%
Male
15
  24.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
American Indian or Alaska Native
2
   3.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  12.9%
White
51
  82.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 62 participants
62
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 62 participants
86.3  (20.1)
Mean Duration of Disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
7.4  (10.1)
Duration of Disease-Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants
≤ 2 years 28
>2 - ≤5 years 10
>5 - 10 years 7
>10 years 17
Number of Tender Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Tender joints
Number Analyzed 62 participants
31.6  (15.2)
[1]
Measure Description: Tender joints are an indicator of rheumatoid arthritis. The number of tender joints in a standard 68 joint count was evaluated. The number of tender joints ranges from 0 to 68, where an increased number of tender joints indicates increasing level of disease severity.
Number of Swollen Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Swollen joints
Number Analyzed 62 participants
20.8  (8.2)
[1]
Measure Description: Swollen joints are an indicator of rheumatoid arthritis. The number of swollen joints in a standard 66 joint count was evaluated. The number of swollen joints ranges from 0 swollen joints to 66, where an increased number of swollen joints indicates increasing level of disease severity.
Participant Pain Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants
64.2  (21.5)
[1]
Measure Description: The participant self-reported pain assessment is a core component of the American College of Rheumatology (ACR)scoring system, where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the most pain possible.
Physical Function (Health Assessment Questionnaire Disability Index [HAQ-DI])   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants
1.5  (0.7)
[1]
Measure Description: The disability section of the full HAQ includes 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and other common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered.
Participant Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants
61.6  (19.7)
[1]
Measure Description: Participant self-reported global rheumatoid arthritis assessment core component of the ACR scoring system, where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the most pain possible.
Physician Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants
62.0  (17.4)
[1]
Measure Description: Physician global rheumatoid arthritis assessment core component of the ACR scoring system, where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the most pain possible.
High Sensitivity C-Reactive Protein (hs-CRP) Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 62 participants
1.7  (1.2)
[1]
Measure Description: hs-CRP is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Levels of hs-CRP can be used to determine the disease activity score.
Disease Activity Score (DAS 28)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants
6.0  (0.8)
[1]
Measure Description: The DAS28 is a continuous disease measure that is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (>5.1), low disease activity (<3.2) and remission (<2.6). A clinically significant response=decrease in DAS28 score of >1.2 from baseline.
Rheumatoid Factor (RF) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants
Positive 46
Negative 16
[1]
Measure Description: RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes that contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤20 IU/mL.
Baseline Methotrexate Dose  
Mean (Standard Deviation)
Unit of measure:  Mg/wk
Number Analyzed 62 participants
17.2  (3.8)
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: participants
Deaths 0
SAEs 2
Treatment-related SAE 0
SAEs Leading to Discontinuation 0
AEs 36
Treatment-related AEs 11
AEs Leading to Discontinuation 0
2.Primary Outcome
Title Number of Participants With AEs of Special Interest in the ACP Device Substudy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous abatacept via the ACP for the duration of the substudy. Abatacept was administered subcutaneously using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: participants
Infections 17
Local injection reactions 5
Systemic injection reactions 2
3.Primary Outcome
Title Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Low hemoglobin (LLN=11.5 g/dL) 1
Low hematocrit (LLN=34%) 1
Low erythrocytes(LLN=3.8 x10*6c/uL) 1
Low platelets (LLN=140*10^9 c/L) 0
High platelets (ULN=450*10^9 c/L) 0
Low leukocytes (LLN= 3.8*10^3 c/uL) 0
High leukocytes (ULN = 10.6*10^3 c/uL) 1
Low neutrophils+bands(LLN=1.8*10^3 c/uL) 0
High eosinophils (ULN= 7*10^3 c/uL) 0
High basophils (ULN= 0.2*10^3 c/uL) 0
High monocytes (ULN=1*10^3 c/uL) 0
Low lymphocytes (LLN= 0.7*10^3 c/uL) 3
High lymphocytes(ULN=4.5*10^3 c/uL) 0
4.Primary Outcome
Title Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
High ALP (ULN=400 U/L) 0
High AST (ULN=44 U/L) 1
High ALT (ULN=55 U/L) 1
High GGT (ULN=65 U/L) 2
High bilirubin (ULN=1.2 mg/dL) 0
High BUN (ULN=26 mg/dL) 1
High creatinine (ULN=1.5 mg/dL) 1
5.Primary Outcome
Title Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Low Na (LLN=135 mEq/L) 0
High Na (ULN=148 mEq/L) 0
Low K (LLN=3.5 mEq/L) 1
High K (ULN=5.5 mEq/L) 1
Low Cl (LLN= 96 mEq/L) 0
High Cl (ULN=109 mEq/L) 0
Low Ca (LLN=8.4 mg/dL) 0
High Ca (ULN=10.6 mg/dL) 0
Low P (LLN=0.8 mg/dL) 0
High P (ULN 5.6 mg/dL) 0
6.Primary Outcome
Title Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Low Glu (n=50) 2
High Glu (n=50) 2
Low fasting Glu (LLN=65 mg/dL) (n=12) 0
High fasting Glu (ULN=115 mg/dL) (n=12) 0
Low protein (LLN=6 g/dL) (n=50) 0
High protein (ULN=8.5 g/dL) (n=50) 0
Low albumin (LLN=3.5 g/dL) (n=50) 0
High uric acid (ULN=8.7 mg/dL) (n=50) 0
High urine protein (normal=trace) (n=50) 0
High urine glucose (normal=negative) (n=50) 2
High urine blood (normal=negative) (n=50) 2
High leukocyte esterase (n=19) 1
High urine WBC (n=25) 10
High urine RBC (n=18) 3
7.Primary Outcome
Title Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: mm Hg
Day 1 before injection (n=62) 128.1  (14.96)
Day 85 (n=50) 130.7  (17.08)
Day 169 before injection (n=42) 128.0  (13.61)
Day 253 before injection (n=15) 127.3  (16.63)
Day 365 (n=4) 135.3  (7.80)
8.Primary Outcome
Title Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: mm Hg
Day 1 before injection (n=62) 76.4  (8.08)
Day 85 (n=50) 78.7  (9.99)
Day 169 before injection (n=42) 75.7  (9.31)
Day 253 before injection (n=15) 78.1  (8.29)
Day 365 (n=4) 77.5  (14.73)
9.Primary Outcome
Title Mean Heart Rate Over Time in the ACP Device Substudy
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: beats per minute
Day 1 before injection (n=62) 73.4  (10.18)
Day 85 (n=50) 74.0  (9.53)
Day 169 before injection (n=42) 73.4  (9.22)
Day 253 before injection (n=15) 76.9  (12.73)
Day 365 (n=4) 84.3  (4.79)
10.Primary Outcome
Title Mean Temperature Over Time in the ACP Device Substudy
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Day 1 before injection (n=62) 36.6  (0.39)
Day 85 (n=50) 36.6  (0.36)
Day 169 before injection (n=42) 36.6  (0.39)
Day 253 before injection (n=15) 36.6  (0.27)
Day 365 (n=4) 36.4  (0.38)
11.Secondary Outcome
Title Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 62
Geometric Mean (Standard Deviation)
Unit of Measure: ug/mL
Day 1 (prior to administration with ACP) (n =53) 24.34  (15.56)
Day 29 (n=52) 27.61  (14.12)
Day 57 (n=39) 31.52  (14.49)
Day 85 (n=47) 27.46  (17.43)
Day 169 (n=35) 26.85  (14.55)
Day 253 (n=5) 24.41  (14.19)
12.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
Day 29 anti-ABA (n=50) 0
Day 29 anti-CTLA4 (n=51) 0
Day 29 total (n=51) 0
Day 57 anti-ABA (n=43) 0
Day 57 anti-CTLA4 (n=43) 1
Day 57 total (n=43) 1
Day 85 anti-ABA (n=42) 0
Day 85 anti-CTLA4 (n=42) 0
Day 85 total (n=42) 0
Overall on-treatment visits anti-ABA (n=53) 0
Overall on-treatment visits anti-CTLA4 (n=53) 1
Overall total on-treatment visits (n=53) 1
28 days post last dose anti-ABA (n=1) 0
28 days post last dose anti-CTLA4 (n=1) 0
28 days post last dose total (n=1) 0
Overall post visits anti-ABA (n=1) 0
Overall post visits anti-CTLA4 (n=1) 0
Overall post visits total (n=1) 0
Overall anti-ABA (n=53) 0
Overall anti-CTLA4 (n=53) 1
Overall total (n=53) 1
13.Secondary Outcome
Title Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Day 29 CTLA4 + possibly Ig (n=57) 0
Day 29 Ig and/or JNCT (n=57) 1
Day 29 total (n=57) 1
Day 57 CTLA4 + possibly Ig (n=47) 0
Day 57 Ig and/or JNCT (n=47) 1
Day 57 total (n=47) 1
Day 85 CTLA4 + possibly Ig (n=49) 0
Day 85 Ig and/or JNCT (n=49) 0
Day 85 total (n=49) 0
Day 169 CTLA4 + possibly Ig (n=43) 0
Day 169 Ig and/or JNCT (n=43) 0
Day 169 total (n=43) 0
Day 253 CTLA4 + possibly Ig (n=2) 0
Day 253 Ig and/or JNCT (n=2) 0
Day 253 total (n=2) 0
Overall on-TRT visits CTLA4 + possibly Ig (n=60) 0
Overall on-TRT visits Ig and/or JNCT (n=60) 1
Overall total on-TRT visits (n=60) 1
28 days post last dose CTLA4 + possibly Ig (n=1) 0
28 days post last dose Ig and/or JNCT (n=1) 0
28 days post last dose total (n=1) 0
56 days post last dose CTLA4 + possibly Ig (n=1) 0
56 days post last dose Ig and/or JNCT (n=1) 0
56 days post last dose total (n=1) 0
85 days post last dose CTLA4 + possibly Ig (n=1) 0
85 days post last dose Ig and/or JNCT (n=1) 0
85 days post last dose total (n=1) 0
Overall post visits CTLA4 + possibly Ig (n=1) 0
Overall post visits Ig and/or JNCT (n=1) 0
Overall post visits total (n=1) 0
Overall CTLA4 + possibly Ig (n=60) 0
Overall Ig and/or JNCT (n=60) 1
Overall total (n=60) 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept Combination Product (ACP)
Hide Arm/Group Description 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).
All-Cause Mortality
Abatacept Combination Product (ACP)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept Combination Product (ACP)
Affected / at Risk (%) # Events
Total   2/62 (3.23%)    
General disorders   
Chest Pain   1/62 (1.61%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal Cell Carcinoma   1/62 (1.61%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept Combination Product (ACP)
Affected / at Risk (%) # Events
Total   4/62 (6.45%)    
Infections and infestations   
Bronchitis   4/62 (6.45%)  4
Upper Respiratory Tract Infection   4/62 (6.45%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01173120     History of Changes
Other Study ID Numbers: IM101-174 (Sub study)
2007-005434-37 ( EudraCT Number )
First Submitted: July 28, 2010
First Posted: July 30, 2010
Results First Submitted: May 3, 2011
Results First Posted: July 6, 2011
Last Update Posted: January 12, 2012