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Phase IIIB Switching From Intravenous to Subcutaneous Study

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ClinicalTrials.gov Identifier: NCT00663702
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : March 26, 2012
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Intervention Drug: Abatacept
Enrollment 123
Recruitment Details Participants were enrolled at 3 locations and 32 sites worldwide: United States (20 sites), Canada (6 sites), and Mexico (6 sites).
Pre-assignment Details A total of 126 participants were enrolled, and 3 discontinued prior to study start due to failure to continue to meet study eligibility criteria.
Arm/Group Title Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure) Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Hide Arm/Group Description Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study. Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Period Title: Overall Study
Started 52 71
Completed 34 61
Not Completed 18 10
Reason Not Completed
Adverse Event             8             4
Withdrawal by Subject             3             1
Pregnancy             0             1
Lost to Follow-up             3             0
Death             1             1
Lack of Efficacy             3             3
Arm/Group Title Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure) Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure) Total
Hide Arm/Group Description Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study. Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study. Total of all reporting groups
Overall Number of Baseline Participants 52 71 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 71 participants 123 participants
56.5  (10.2) 52.8  (13.8) 54.3  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 71 participants 123 participants
Female
42
  80.8%
59
  83.1%
101
  82.1%
Male
10
  19.2%
12
  16.9%
22
  17.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Partcipants
Number Analyzed 52 participants 71 participants 123 participants
White 47 70 117
Black/African American 3 0 3
American Indian/Alaska Native 1 0 1
Asian 0 1 1
Other 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 71 participants 123 participants
North America 52 16 68
South America 0 55 55
Mean Baseline High Sensitivity C-Reactive Protein Level  
Mean (Standard Deviation)
Unit of measure:  μg/mL
Number Analyzed 52 participants 71 participants 123 participants
0.94  (0.65) 0.92  (0.88) 0.93  (0.79)
Mean Baseline 28 Joint Disease Activity Score (DAS 28)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 52 participants 71 participants 123 participants
3.55  (1.20) 3.28  (1.29) 3.39  (1.26)
[1]
Measure Description: The DAS 28 is a 28-item joint disease activity score used to quantify disease expression and progression in rheumatoid arthritis. Severity is indicated with increasing item score on the scale with 0=no joints affected and 28=all joints affected.
Mean Number of Tender Joints at Baseline  
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 52 participants 71 participants 123 participants
9.1  (12.8) 8.8  (12.4) 8.9  (12.5)
Mean Number of Swollen Joints at Baseline  
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 52 participants 71 participants 123 participants
5.4  (6.4) 4.3  (5.9) 4.8  (6.1)
Participant Weight at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 71 participants 123 participants
Less than 60 kilograms 9 14 23
60-100 kilograms 30 54 84
Greater than 100 kilograms 10 3 13
Missing 3 0 3
1.Primary Outcome
Title Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
Hide Description An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.
Time Frame Day 1 (Baseline) through Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Deaths 0
SAEs 1
Treatment-related SAEs 0
SAEs leading to discontinuation 0
Treatment-related AEs 11
AEs leading to discontinuation 1
AEIs: Infections 20
AEIs: Malignancy 0
AEIs: Automimmune disorders (prespecified) 0
AEIs: Injection reactions (prespecified) Local 2
AEIs: Injection reactions (prespecified) Systemic 2
2.Primary Outcome
Title Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
Hide Description An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.
Time Frame Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Deaths 4
SAEs 43
Treatment-related SAEs 11
SAEs leading to discontinuation 8
Treatment-related AEs 60
AEs leading to discontinuation 11
3.Primary Outcome
Title Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.
Time Frame Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Hemoglobin, low (n=120) 7
Hematocrit, low (n=119) 4
Erythrocytes, low (n=120) 4
Platelet count, low (n=120) 2
Leukocytes, low (n=120) 2
Leukocytes, high (n=120) 3
Eosinophils (absolute), high (n=122) 12
Lymphocytes (absolute), low (n=122) 15
4.Primary Outcome
Title Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.
Time Frame Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Alkaline phosphatase, high (n=120) 1
Aspartate aminotransferase, high (n=120) 3
Alanine aminotransferase, high (n=120) 6
G-glutamyl transferase, high (n=120) 7
Blood urea nitrogen, high (n=120) 5
Creatinine, high (n=120) 11
5.Primary Outcome
Title Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, <LLN.
Time Frame Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Sodium, serum, low (mEq/L) (n=120) 2
Potassium, serum, low (mEq/L) (n=120) 6
Phosphorus, inorganic, low (mg/dL) (n=120) 2
6.Primary Outcome
Title Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Hide Description LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .
Time Frame Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Glucose, serum, low (n=122) 17
Glucose, serum, high (n=122) 12
Glucose, serum, fasting, low (n=59) 5
Glucose, serum, fasting, high (n=59) 3
Protein, total, low (n=120) 1
Protein, total, high (n=120) 1
Albumin, low (n=120) 3
7.Primary Outcome
Title Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
Hide Description preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.
Time Frame Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Protein, urine, high (n=122) 12
Glucose, urine, high (n=122) 8
Blood, urine, high (n=122) 28
Leukocyte esterase, urine, high (n=95) 32
White blood cells, urine, high (n=103) 64
Red blood cells, urine, high (n=91) 33
8.Primary Outcome
Title Number of Participants With Adverse Events of Special Interest
Hide Description AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).
Time Frame Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: Participants
Infections 96
Malignancies 7
Prespecified autoimmune disorders 7
Prespecified systemic injection reactions 14
9.Primary Outcome
Title Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Hide Description BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Time Frame Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: mm Hg
Sitting Systolic BP Day 1 121.6  (16.15)
Sitting Systolic BP Day 29 (n=120) 123.6  (16.08)
Sitting Systolic BP Day 57 (n=120) 123.9  (16.95)
Sitting Systolic BP Day 85 (n=120) 124.3  (16.62)
Sitting Systolic BP Day 169 (n=116) 124.0  (15.09)
Sitting Systolic BP Day 253 (n=114) 122.3  (14.58)
Sitting Systolic BP Day 365 (n=114) 124.1  (15.0)
Sitting Systolic BP Day 449 (n=111) 123.9  (15.80)
Sitting Systolic BP Day 533 (n=108) 123.5  (15.08)
Sitting Systolic BP Day 617 (n=109) 124.4  (16.03)
Sitting Systolic BP Day 729 (n=108) 125.2  (16.09)
Sitting Systolic BP Day 813 (n=105) 125.6  (16.04)
Sitting Systolic BP Day 897 (n=102) 122.8  (13.15)
Sitting Systolic BP Day 981 (n=101) 123.5  (15.44)
Sitting Systolic BP Day 1093 (n=98) 122.9  (13.46)
Sitting Systolic BP Day 1177 (n=84) 124.4  (13.66)
Sitting Systolic BP Day 1261 (n=73) 123.0  (15.29)
Sitting Systolic BP Day 1345 (n=64) 120.6  (12.27)
Sitting Systolic BP Day 1457 (n=64) 124.5  (13.17)
Sitting Systolic BP Day 1541 (n=64) 121.0  (13.75)
Sitting Systolic BP Day 1625 (n=64) 123.4  (14.71)
Sitting Systolic BP Day 1709 (n=48) 122.7  (15.55)
Sitting Systolic BP Day 1821 (n=3) 123.7  (15.18)
Sitting Diastolic BP Day 1 (n=123) 73.9  (8.83)
Sitting Diastolic BP Day 29 (n=120) 75.6  (9.28)
Sitting Diastolic BP Day 57 (n=120) 74.3  (8.82)
Sitting Diastolic BP Day 85 (n=120) 74.9  (10.37)
Sitting Diastolic BP Day 169 (n=116) 74.3  (9.19)
Sitting Diastolic BP Day 253 (n=114) 73.9  (9.96)
Sitting Diastolic BP Day 365 (n=114) 74.0  (9.98)
Sitting Diastolic BP Day 449 (n=111) 74.4  (9.53)
Sitting Diastolic BP Day 533 (n=108) 74.8  (10.08)
Sitting Diastolic BP Day 617 (n=109) 74.9  (9.72)
Sitting Diastolic BP Day 79 (n=108) 75.5  (9.83)
Sitting Diastolic BP Day 813 (n=105) 75.8  (10.20)
Sitting Diastolic BP Day 897 (n=102) 75.0  (10.23)
Sitting Diastolic BP Day 981 (n=101) 75.2  (9.35)
Sitting Diastolic BP Day 1093 (n=98) 76.2  (10.78)
Sitting Diastolic BP Day1177 (n=84) 77.6  (9.04)
Sitting Diastolic BP Day 1261 (n=73) 76.3  (9.94)
Sitting Diastolic BP Day 1345 (n=64) 75.4  (8.21)
Sitting Diastolic BP Day 1457 (n=64) 76.8  (7.14)
Sitting Diastolic BP Day 1541 (n=64) 75.6  (9.53)
Sitting Diastolic BP Day 1625 (n=64) 75.6  (9.36)
Sitting Diastolic BP Day 1709 (n=48) 75.2  (9.74)
Sitting Diastolic BP Day 1821 (n=3) 69.3  (8.14)
10.Primary Outcome
Title Mean Heart Rate
Hide Description Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Time Frame Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1 74.2  (9.56)
Day 29 (n=120) 74.9  (8.35)
Day 57 (n=120) 74.6  (8.63)
Day 85 (n=120) 74.5  (8.90)
Day 169 (n=119) 73.6  (9.05)
Day 253 (n=115) 73.9  (9.74)
Day 365 (n=114) 73.8  (9.37)
Day 449 (n=111) 73.5  (9.12)
Day 533 (n=109) 72.7  (8.41)
Day 617 (n=109) 73.6  (9.83)
Day 729 (n=108) 74.2  (9.71)
Day 813 (n=105) 72.8  (7.76)
Day 897 (n=102) 72.4  (10.05)
Day 981 (n=101) 73.0  (8.90)
Day 1093 (n=98) 71.9  (9.07)
Day 1177 (n=84) 72.6  (8.33)
Day 1261 (n=73) 72.3  (9.41)
Day 1345 (n=64) 72.6  (8.02)
Day 1457 (n=64) 72.1  (7.78)
Day 1541 (n=64) 72.7  (8.90)
Day 1625 (n=64) 72.5  (8.73)
Day 1709 (n=48) 74.0  (9.78)
Day 1821 (n=3) 74.0  (6.24)
11.Primary Outcome
Title Mean Temperature
Hide Description Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Time Frame Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
Day 1 36.4  (0.49)
Day 29 (n=120) 36.4  (0.43)
Day 57 (n=120) 36.3  (0.40)
Day 85 (n=120) 36.4  (0.43)
Day 169 (n=119) 36.4  (0.41)
Day 253 (n=115) 36.4  (0.38)
Day 365 (n=114) 36.3  (0.39)
Day 449 (n=111) 36.4  (0.46)
Day 533 (n=109) 36.4  (0.38)
Day 617 (n=109) 36.4  (0.41)
Day 729 (n=108) 36.3  (0.33)
Day 813 (n=105) 36.3  (0.48)
Day 897 (n=102) 36.4  (0.36)
Day 981 (n=101) 36.4  (0.44)
Day 1093 (n=98) 36.3  (0.43)
Day 1177 (n=84) 36.3  (0.39)
Day 1261 (n=73) 36.3  (0.41)
Day 1345 (n=64) 36.3  (0.33)
Day 1457 (n=64) 36.3  (0.39)
Day 1541 (n=64) 36.2  (0.36)
Day 1625 (n=64) 36.2  (0.43)
Day 1709 (n=48) 36.2  (0.37)
Day 1821 (n=3) 36.7  (0.21)
12.Secondary Outcome
Title Mean Trough Serum Concentration (Cmin) of Abatacept
Hide Description Cmin of abatacept was determined from serum samples.
Time Frame Days 29, 85, 57, and 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 123
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Day 29 (n=116)
34.31
(46%)
Day 57 (n=117)
34.25
(48%)
Day 85 (n=118)
33.78
(48%)
13.Secondary Outcome
Title Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85
Hide Description Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.
Time Frame Day 1 (Baseline) through Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 122
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-abatacept (n=85) 8.2
Anti-CTLA4-T9 (n=122) 0.8
14.Secondary Outcome
Title Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85
Hide Description

Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers >10) included:

  • A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline
  • A negative baseline immunogenicity response and a positive immunogenicity response postbaseline
  • A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value
Time Frame Day 1 (Baseline) through Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 122
Measure Type: Number
Unit of Measure: Percentage of participants
0
15.Secondary Outcome
Title Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Hide Description The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Time Frame Day 1 (Baseline) through Day 1093
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication
Arm/Group Title Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure) Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 52 71
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 29 (n=50, 69) 3.60  (1.24) 2.95  (1.31)
Day 57 (n=49, 69) 3.36  (1.11) 2.96  (1.37)
Day 85 (n=49, 70) 3.44  (1.14) 2.91  (1.30)
Day 169 (n=48, 71) 3.45  (1.10) 2.93  (1.29)
Day 253 (n=46, 71) 3.60  (1.33) 3.01  (1.21)
Day 365 (n=45, 70) 3.51  (1.32) 3.09  (1.25)
Day 449 (n=43, 69) 3.58  (1.33) 3.21  (1.35)
Day 533 (n=43, 68) 3.51  (1.23) 3.08  (1.43)
Day 617 (n=41, 67) 3.31  (1.20) 3.16  (1.37)
Day 729 (n=41, 67) 3.30  (1.12) 3.15  (1.26)
Day 813 (n=39, 65) 3.38  (1.17) 2.81  (1.05)
Day 897 (n=38, 65) 3.41  (1.46) 3.02  (1.19)
Day 981 (n=38, 65) 3.32  (1.37) 3.02  (1.28)
Day 1093 (n=34, 65) 3.21  (1.26) 3.10  (1.37)
16.Secondary Outcome
Title Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Hide Description LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP <2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Time Frame Day 1 (Baseline) through Day 1093
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication
Arm/Group Title Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure) Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 52 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
LDAS Day 29 (n=50, 69)
40.0
(26.4 to 53.6)
68.1
(57.1 to 79.1)
Remission Day 29 (n=50, 69)
24.0
(12.2 to 35.8)
50.7
(38.9 to 62.5)
LDAS Day 57 (n=49, 69)
44.9
(31.0 to 58.8)
60.9
(49.4 to 72.4)
Remission Day 57 (n=49, 69)
26.5
(14.2 to 38.9)
47.8
(36.0 to 59.6)
LDAS Day 85 (n=49, 70)
40.8
(27.1 to 54.6)
64.3
(53.1 to 75.5)
Remission Day 85 (n=49, 70)
24.5
(12.4 to 36.5)
48.6
(36.9 to 60.3)
LDAS Day 169 (n=48, 71)
39.6
(25.7 to 53.4)
59.2
(47.7 to 70.6)
Remission Day 169 (n=48, 71)
25.0
(12.8 to 37.2)
49.3
(37.7 to 60.9)
LDAS Day 253 (n=46, 71)
39.1
(25.0 to 53.2)
66.2
(55.2 to 77.2)
Remission Day 253 (n=46, 71)
30.4
(17.1 to 43.7)
42.3
(30.8 to 53.7)
LDAS Day 365 (n=45, 70)
40.0
(25.7 to 54.3)
57.1
(45.5 to 68.7)
Remission Day 365 (n=45, 70)
33.3
(19.6 to 47.1)
42.9
(31.3 to 54.5)
LDAS Day 449 (n=43, 69)
41.9
(27.1 to 56.6)
53.6
(41.9 to 65.4)
Remission Day 449 (n=43, 69)
30.2
(16.5 to 44.0)
43.5
(31.8 to 55.2)
LDAS Day 533 (n=43, 68)
37.2
(22.8 to 51.7)
60.3
(48.7 to 71.9)
Remission Day 533 (n=43, 68)
23.3
(10.6 to 35.9)
48.5
(36.7 to 60.4)
LDAS Day 617 (n=41, 67)
46.3
(31.1 to 61.6)
53.7
(41.8 to 65.7)
Remission Day 617 (n=41, 67)
29.3
(15.3 to 43.2)
43.3
(31.4 to 55.1)
LDAS Day 729 (n=41, 67)
41.5
(26.4 to 56.5)
59.7
(48.0 to 71.4)
Remission Day 729 (n=41, 67)
29.3
(15.3 to 43.2)
34.3
(23.0 to 45.7)
LDAS Day 813 (n=39, 65)
43.6
(28.0 to 59.2)
69.2
(58.0 to 80.5)
Remission Day 813 (n=39, 65)
25.6
(11.9 to 39.3)
46.2
(34.0 to 58.3)
LDAS Day 897 (n=38, 65)
50.0
(34.1 to 65.9)
60.0
(48.1 to 71.9)
Remission Day 897 (n=38, 65)
34.2
(19.1 to 49.3)
43.1
(31.0 to 55.1)
DLAS Day 981 (n=38, 65)
50.0
(34.1 to 65.9)
64.6
(53.0 to 76.2)
Remission Day 981 (n=38, 65)
42.1
(26.4 to 57.8)
46.2
(34.0 to 58.3)
LDAS Day 1093 (n=34, 65)
52.9
(36.2 to 69.7)
58.5
(46.5 to 70.4)
Remission Day 1093 (n=34, 65)
41.2
(24.6 to 57.7)
50.8
(38.6 to 62.9)
17.Secondary Outcome
Title Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Hide Description The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.
Time Frame Day 1 (Baseline) to Day 1093
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication
Arm/Group Title Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure) Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Hide Arm/Group Description:
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Overall Number of Participants Analyzed 52 71
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 29 (n=51, 69) 0.98  (0.70) 0.80  (0.67)
Day 57 (n=50, 71) 0.92  (0.68) 0.80  (0.67)
Day 85 (n=49, 71) 0.92  (0.67) 0.82  (0.69)
Day 169 (n=49, 71) 0.97  (0.67) 0.87  (0.74)
Day 253 (n=48, 71) 0.97  (0.69) 0.87  (0.73)
Day 365 (n=46, 70) 0.96  (0.66) 0.85  (0.69)
Day 449 (n=43, 69) 0.97  (0.75) 0.89  (0.69)
Day 533 (n=43, 68) 1.07  (0.71) 0.94  (0.71)
Day 617 (n=42, 67) 0.99  (0.74) 0.87  (0.69)
Day 729 (n=42, 67) 0.98  (0.74) 0.90  (0.71)
Day 813 (n=40, 66) 1.02  (0.74) 0.88  (0.68)
Day 897 (n=39, 65) 1.06  (0.75) 0.89  (0.73)
Day 981 (n=39, 65) 1.02  (0.76) 0.91  (0.69)
Day 1093 (n=34, 65) 0.96  (0.74) 0.92  (0.74)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subcutaneous Abatacept, 125 mg
Hide Arm/Group Description Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
All-Cause Mortality
Subcutaneous Abatacept, 125 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subcutaneous Abatacept, 125 mg
Affected / at Risk (%)
Total   43/123 (34.96%) 
Blood and lymphatic system disorders   
Pancytopenia  1  2/123 (1.63%) 
Cardiac disorders   
Pericardial effusion  1  1/123 (0.81%) 
Angina pectoris  1  1/123 (0.81%) 
Cardiac failure congestive  1  1/123 (0.81%) 
Myocardial ischaemia  1  1/123 (0.81%) 
Coronary artery disease  1  1/123 (0.81%) 
Coronary artery occlusion  1  1/123 (0.81%) 
Angina unstable  1  1/123 (0.81%) 
Bundle branch block left  1  1/123 (0.81%) 
Gastrointestinal disorders   
Colonic fistula  1  1/123 (0.81%) 
Colitis  1  1/123 (0.81%) 
Hiatus hernia  1  2/123 (1.63%) 
Diverticular perforation  1  1/123 (0.81%) 
Gastric polyps  1  1/123 (0.81%) 
Intestinal perforation  1  1/123 (0.81%) 
Pancreatitis acute  1  1/123 (0.81%) 
General disorders   
Chest pain  1  2/123 (1.63%) 
Device failure  1  1/123 (0.81%) 
Hepatobiliary disorders   
Cholelithiasis  1  2/123 (1.63%) 
Immune system disorders   
Sarcoidosis  1  1/123 (0.81%) 
Infections and infestations   
Diverticulitis  1  1/123 (0.81%) 
Bronchitis  1  1/123 (0.81%) 
Appendicitis  1  1/123 (0.81%) 
Dengue fever  1  1/123 (0.81%) 
Pneumonia  1  4/123 (3.25%) 
Soft tissue infection  1  1/123 (0.81%) 
Urosepsis  1  1/123 (0.81%) 
Cholecystitis infective  1  1/123 (0.81%) 
Gastroenteritis  1  1/123 (0.81%) 
Injury, poisoning and procedural complications   
Pelvic fracture  1  1/123 (0.81%) 
Hip fracture  1  2/123 (1.63%) 
Radius fracture  1  1/123 (0.81%) 
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/123 (0.81%) 
Musculoskeletal and connective tissue disorders   
Rheumatoid arthritis  1  1/123 (0.81%) 
Foot deformity  1  1/123 (0.81%) 
Osteoarthritis  1  4/123 (3.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/123 (0.81%) 
Lung adenocarcinoma metastatic  1  1/123 (0.81%) 
Brain neoplasm benign  1  1/123 (0.81%) 
Uterine cancer  1  1/123 (0.81%) 
Basal cell carcinoma  1  1/123 (0.81%) 
Colorectal cancer  1  1/123 (0.81%) 
Gallbladder adenocarcinoma  1  1/123 (0.81%) 
Transitional cell carcinoma  1  1/123 (0.81%) 
Nervous system disorders   
Cerebrovascular accident  1  1/123 (0.81%) 
Aphasia  1  1/123 (0.81%) 
Renal and urinary disorders   
Renal colic  1  1/123 (0.81%) 
Reproductive system and breast disorders   
Cervical dysplasia  1  1/123 (0.81%) 
Ovarian cyst  1  1/123 (0.81%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/123 (0.81%) 
Respiratory failure  1  1/123 (0.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Subcutaneous Abatacept, 125 mg
Affected / at Risk (%)
Total   101/123 (82.11%) 
Blood and lymphatic system disorders   
Anaemia  1  9/123 (7.32%) 
Eye disorders   
Cataract  1  7/123 (5.69%) 
Gastrointestinal disorders   
Diarrhoea  1  7/123 (5.69%) 
Gastritis  1  7/123 (5.69%) 
Nausea  1  9/123 (7.32%) 
General disorders   
Oedema peripheral  1  9/123 (7.32%) 
Influenza like illness  1  8/123 (6.50%) 
Infections and infestations   
Bronchitis  1  14/123 (11.38%) 
Nasopharyngitis  1  34/123 (27.64%) 
Pharyngitis  1  7/123 (5.69%) 
Sinusitis  1  10/123 (8.13%) 
Urinary tract infection  1  24/123 (19.51%) 
Conjunctivitis  1  9/123 (7.32%) 
Gastroenteritis  1  9/123 (7.32%) 
Upper respiratory tract infection  1  30/123 (24.39%) 
Injury, poisoning and procedural complications   
Fall  1  9/123 (7.32%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  13/123 (10.57%) 
Nervous system disorders   
Headache  1  10/123 (8.13%) 
Dizziness  1  10/123 (8.13%) 
Psychiatric disorders   
Depression  1  7/123 (5.69%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  17/123 (13.82%) 
Vascular disorders   
Hypertension  1  10/123 (8.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: clinical.trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00663702     History of Changes
Other Study ID Numbers: IM101-185
First Submitted: April 18, 2008
First Posted: April 22, 2008
Results First Submitted: January 19, 2012
Results First Posted: March 26, 2012
Last Update Posted: March 9, 2015