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BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00095173
Recruitment Status : Completed
First Posted : November 2, 2004
Results First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Juvenile Rheumatoid Arthritis
Interventions Drug: Abatacept
Drug: Placebo
Enrollment 214
Recruitment Details  
Pre-assignment Details 214 enrolled; in Per A, 190 treated; 24 not treated due to screening failures.170 completed Per A, 123 responders qualified to enter Per B. One subject did not enter Per B; 122 responders were randomized, 60 abatacept and 62 placebo. 36 of 47 Per A non-responders re-entered at Per C. Protocol violation occurred; 5yr old participant.
Arm/Group Title Abatacept (All Participants in Period A) Abatacept (Period B) Placebo (Period B) Abatacept (Period A Non-Responders in Period C) Abatacept (Period C) Placebo (Period B) to Abatacept (Period C)
Hide Arm/Group Description Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare (Period B). Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion. Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) or once a month for up to 5 years (Period C). Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years. Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Period Title: Open-Label Lead-In Phase (Period A)
Started 190 0 0 0 0 0
Completed 170 0 0 0 0 0
Not Completed 20 0 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0
Lack of Efficacy             17             0             0             0             0             0
Withdrawal by Subject             1             0             0             0             0             0
Not specified             1             0             0             0             0             0
Period Title: Double-Blind Phase (Period B)
Started 0 [1] 60 [2] 62 [2] 0 0 0
Completed 0 49 31 0 0 0
Not Completed 0 11 31 0 0 0
Reason Not Completed
Lack of Efficacy             0             10             31             0             0             0
Withdrawal by Subject             0             1             0             0             0             0
[1]
All participants did not continue; responders entered Period B; non-responders re-entered Period C.
[2]
123 responders from Period A qualified;122 entered and were randomized to abatacept and placebo.
Period Title: Open-Label Extension Phase (Period C)
Started 0 0 0 36 [1] 58 [2] 59 [3]
Completed 0 0 0 13 29 27
Not Completed 0 0 0 23 29 32
Reason Not Completed
Death             0             0             0             0             0             1
Adverse Event             0             0             0             1             2             3
Lack of Efficacy             0             0             0             11             5             8
Lost to Follow-up             0             0             0             2             5             6
Withdrawal by Subject             0             0             0             4             6             0
No Longer Meets Study Criteria             0             0             0             0             1             1
Poor/Non-Compliance             0             0             0             0             2             2
Pregnancy             0             0             0             1             2             3
Not Specified             0             0             0             4             6             8
[1]
Participants were non-responders from Period A who re-entered in Period C.
[2]
Includes 47 who completed Period B with no flare and 11 who discontinued Period B due to a flare
[3]
Includes 33 who discontinued Period B due to a flare and 26 who completed Period B with no flare
Arm/Group Title Abatacept (All Participants in Period A)
Hide Arm/Group Description Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.
Overall Number of Baseline Participants 190
Hide Baseline Analysis Population Description
All treated participants in the Lead-In Phase (Period A)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 190 participants
13.0
(5.0 to 17.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
137
  72.1%
Male
53
  27.9%
1.Primary Outcome
Title Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)
Hide Description

Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed.

All of the following criteria must be met to be defined as a flare:

  • > 30% worsening in at least 3 of the 6 JRA/JIA core response variables
  • > 30% improvement in not more than 1 of the 6 JRA/JIA core set variables
  • ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare
  • worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)
Time Frame Period B (Day 113 to Day 282)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept (Period B) Placebo (Period B)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
Overall Number of Participants Analyzed 60 62
Median (Full Range)
Unit of Measure: months
NA [1] 
(NA to NA)
6
(0.73 to 6.87)
[1]
Fewer than 50% of the participants in the abatacept group experienced a flare, therefore the median time to flare is known to exceed 6 months, but cannot be estimated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (Period B), Placebo (Period B)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.16 to 0.59
Estimation Comments Abatacept over placebo
2.Secondary Outcome
Title Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)
Hide Description

All of the following criteria must be met to be defined as a flare:

  • > 30% worsening in at least 3 of the 6 JRA/JIA core response variables
  • > 30% improvement in not more than 1 of the 6 JRA/JIA core set variables
  • ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare
  • worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)
Time Frame Period B (Day 113 to Day 282)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept (Period B) Placebo (Period B)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: participants
12 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (Period B), Placebo (Period B)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)
Hide Description

AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.

SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).

Time Frame Period A (Day 1 to Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Periods A
Arm/Group Title Abatacept (All Participants in Period A)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
SAE 6
Treatment-Related AE 0
All Deaths 0
Treatment-Related Deaths 0
Discontinuation of Study Drug due to AEs 1
4.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)
Hide Description

AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.

SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).

Time Frame Period B (Day 113 to Day 282)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Periods B
Arm/Group Title Abatacept (Period B) Placebo (Period B)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: participants
SAE 0 2
Treatment-Related AE 0 0
All Deaths 0 0
Treatment-Related Deaths 0 0
Discontinuation of Study Drug due to AEs 0 0
5.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)
Hide Description AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).
Time Frame Period C (Day 282 to end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Period C
Arm/Group Title Abatacept (Period A Non-Responders in Period C) Abatacept (Period C) Placebo (Period B) to Abatacept (Period C)
Hide Arm/Group Description:
Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Overall Number of Participants Analyzed 36 58 59
Measure Type: Number
Unit of Measure: participants
SAE 9 9 12
Treatment-Related AE 2 4 3
All Deaths 0 0 1
Treatment-Related Deaths 0 0 0
Discontinuation of Study Drug due to AEs 1 2 3
6.Secondary Outcome
Title Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
Hide Description Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.
Time Frame Period B (Day 113 to Day 282)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Period B
Arm/Group Title Abatacept (Period B) Placebo (Period B)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
Overall Number of Participants Analyzed 60 62
Median (Inter-Quartile Range)
Unit of Measure: percentage change from baseline
Active Joints
-20.9
(-92.0 to 17.86)
50.00
(0.00 to 100.0)
Joints with LOM
0.00
(-45.5 to 0.00)
50.00
(0.00 to 100.0)
Physician Global Assessment
-29.8
(-86.3 to 22.48)
55.95
(-31.3 to 250.0)
Parent Global Assessment
-11.2
(-56.8 to 28.41)
8.39
(-31.8 to 100.0)
CHAQ Disability Index
0.00
(-38.9 to 2.17)
0.00
(-13.3 to 55.56)
ESR
0.00
(-20.7 to 50.00)
20.50
(-14.3 to 92.00)
CRP
0.00
(-46.6 to 67.00)
6.25
(-33.3 to 150.0)
7.Secondary Outcome
Title Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
Hide Description Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.
Time Frame Period C (Day 282 to end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Period C
Arm/Group Title Abatacept (Period A Non-Responders in Period C) Abatacept (Period C) Placebo (Period B) to Abatacept (Period C)
Hide Arm/Group Description:
Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Overall Number of Participants Analyzed 36 58 59
Median (Inter-Quartile Range)
Unit of Measure: percentage change from baseline
Active Joints
-26.7
(-66.7 to 0.00)
-70.2
(-94.1 to -50.0)
-82.4
(-100 to -62.5)
Joints with Limited Range of Motion
0.00
(-33.3 to 36.67)
-50.0
(-75.0 to -27.3)
-71.4
(-86.2 to -23.1)
Physician Global Assessment of Disease Severity
-31.9
(-50.0 to -9.33)
-75.0
(-91.3 to -52.3)
-81.8
(-91.4 to -64.3)
Parent Global Assessment of Overall Well-Being
1.96
(-19.6 to 26.67)
-62.7
(-93.8 to -27.5)
-63.9
(-84.2 to -38.8)
CHAQ Disability Index
14.14
(-16.7 to 100.0)
-56.7
(-81.8 to -18.2)
-45.5
(-75.0 to -12.5)
ESR
20.87
(-15.5 to 83.77)
-27.3
(-54.8 to 20.00)
-24.2
(-50.0 to 0.00)
CRP
0.00
(-31.6 to 43.68)
-33.8
(-84.4 to 54.84)
-27.8
(-75.0 to 11.11)
8.Secondary Outcome
Title Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Hide Description The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.
Time Frame Period A (Day 1 to Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Period A
Arm/Group Title Abatacept (All Participants in Period A)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
Infections and Infestations 68
Peri-Infusional AEs 30
Autoimmune Disorders 2
Malignancies 0
9.Secondary Outcome
Title Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Hide Description The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.
Time Frame Period B (Day 113 to Day 282)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Period B
Arm/Group Title Abatacept (Period B) Placebo (Period B)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: participants
Infections and Infestations 27 27
Peri-Infusional AEs 2 2
Autoimmune Disorders 0 0
Malignancies 0 0
10.Secondary Outcome
Title Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Hide Description The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.
Time Frame Period C (Day 282 up to 56 days after the last dose of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Period C
Arm/Group Title Abatacept (All Participants in Period C)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Overall Number of Participants Analyzed 153
Measure Type: Number
Unit of Measure: participants
Infections and Infestations 120
Peri-Infusional AEs 22
Autoimmune Disorders 7
Malignancies 1
11.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate
Hide Description The ACRP30 response criteria were defined as a ≥ 30% improvement over baseline in ESR. ACRP 50, 70, and 90 responses were defined similarly with 50%, 70%, and 90% improvements required, respectively.
Time Frame Day 113, Day 282, and Day 2047
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept (Period A Non-Responders in Period C) Abatacept (Period C) Placebo (Period B) to Abatacept (Period C)
Hide Arm/Group Description:
Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Overall Number of Participants Analyzed 36 58 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
ACR Pediatric 30 (ESR) at Day 113
0 [1] 
(NA to NA)
100 [2] 
(NA to NA)
100 [2] 
(NA to NA)
ACR Pediatric 30 (ESR) at Day 282
NA [3] 
(NA to NA)
84.5
(75.2 to 93.8)
67.8
(55.9 to 79.7)
ACR Pediatric 30 (ESR) at Day 2047
69.2
(44.1 to 94.3)
97.0
(91.1 to 100)
86.7
(74.5 to 98.8)
ACR Pediatric 50 (ESR) at Day 113
0 [1] 
(NA to NA)
65.5
(53.3 to 77.7)
88.1
(79.9 to 96.4)
ACR Pediatric 50 (ESR) at Day 282
NA [3] 
(NA to NA)
79.3
(68.9 to 89.7)
52.5
(39.8 to 65.3)
ACR Pediatric 50 (ESR) at Day 2047
69.2
(44.1 to 94.3)
93.9
(85.8 to 100.0)
80.0
(65.7 to 94.3)
ACR Pediatric 70 (ESR) at Day 113
0 [1] 
(NA to NA)
37.9
(25.4 to 50.4)
49.2
(36.4 to 61.9)
ACR Pediatric 70 (ESR) at Day 282
NA [3] 
(NA to NA)
55.2
(42.4 to 68.0)
30.5
(18.8 to 42.3)
ACR Pediatric 70 (ESR) at Day 2047
53.8
(26.7 to 80.9)
78.8
(64.8 to 92.7)
63.3
(46.1 to 80.6)
ACR Pediatric 90 (ESR) at Day 113
0 [1] 
(NA to NA)
17.2
(7.5 to 27.0)
22.0
(11.5 to 32.6)
ACR Pediatric 90 (ESR) at Day 282
NA [3] 
(NA to NA)
41.4
(28.7 to 54.1)
15.3
(6.1 to 24.4)
ACR Pediatric 90 (ESR) at Day 2047
38.5
(12.0 to 64.9)
66.7
(50.6 to 82.8)
40.0
(22.5 to 57.5)
[1]
No participants with response
[2]
Confidence interval not applicable if result is 100%
[3]
No participants in this group
12.Secondary Outcome
Title Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Hide Description Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Alanine Aminotransferase, 0-40 units per liter (U/L);G-Glutamyl Transferase, 0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter (mg/dL);Blood Urea Nitrogen, 5.9-26.0 mg/dL;Creatinine, 0.50-1.50 mg/dL;Serum Potassium, 3.5-5.5 milliequivalents per liter (mEq/L);Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin, 3.5-5.5 g/dL;Urine Protein, >=4;Urine Glucose, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.
Time Frame Period A (Day 1 to Day 113)
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Hide Analysis Population Description
All treated participants in Period C evaluated for a specific analyte.
Arm/Group Title Abatacept (All Participants in Period A)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
Hemoglobin (Low) n=189 2
Hematocrit (Low) n=189 2
Erythrocytes (Low) n=189 1
Platelets (Low) n=189 1
Platelet Count (High) n=189 2
Leukocytes (Low) n=189 9
Leukocytes (High) n=189 10
Absolute Neutrophils + Bands (Low) n=189 5
Absolute Lymphocytes (Low) n=189 9
Absolute Eosinophils (High) n=189 16
Alanine Aminotransferase (ALT, High) n=190 2
G-Glutamyl Transferase (GGT, High) n=190 1
Bilirubin (Total, High) n=190 1
Blood Urea Nitrogen (High) n=190 6
Creatinine (High) n=190 12
Potassium (High) n=190 4
Serum Glucose (Low) n=190 26
Serum Glucose (High) n=190 2
Fasting Serum Glucose (High) n=109 1
Total Protein (High) n=190 2
Albumin (Low) n=190 2
Urine Protein (High) n=190 12
Urine Glucose (High) n=190 1
Urine Blood (High) n=190 23
Urine White Blood Cells (High) n=75 9
Urine Red Blood Cells (High) n=75 25
13.Secondary Outcome
Title Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Hide Description Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Aspartate Aminotransferase, 0-40 units per liter (U/L); Alanine Aminotransferase, 0-40 U/L;Blood Urea Nitrogen, 5.9-26.0 mg/dL;Serum Sodium, 135-148 milliequivalents per liter (mEq/L);Serum Potassium, 3.5-5.5 mEq/L;Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Urine Protein, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.
Time Frame Period B (Day 113 to Day 282)
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Hide Analysis Population Description
All treated participants in Period B evaluated for a specific analyte.
Arm/Group Title Abatacept (Period B) Placebo (Period B)
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Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: participants
Hemoglobin (Low) n=60, 61 1 1
Hematocrit (Low) n=60, 61 1 1
Erythrocytes (Low) n=60, 61 0 1
Platelets (Low) n-60, 61 4 0
Platelets (High) n=189 0 1
Leukocytes (Low) n=60, 61 1 1
Leukocytes (High) n=60, 61 1 2
Absolute Neutrophils + Bands (Low) n=60, 62 0 1
Absolute Lymphocytes (Low) n=60, 62 2 3
Absolute Eosinophils (High) n=60, 62 6 4
Aspartate Aminotransferase (AST, High) n=60, 62 1 0
Alanine Aminotransferase (ALT, High) n=60, 62 1 0
Blood Urea Nitrogen (High) n=60, 62 1 1
Serum Sodium (Low) n=60, 62 0 1
Serum Potassium (High) n=60, 62 2 0
Serum Glucose (Low) n=60, 62 4 5
Serum Glucose (High) n=60, 62 0 1
Fasting Serum Glucose (High) n=60, 62 1 1
Urine Protein (High) n=62 2 2
Urine Blood (High) n=60, 62 12 6
Urine White Blood Cells (High) n=24, 20 5 2
Urine Red Blood Cells (High) n=24, 20 6 4
14.Secondary Outcome
Title Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Hide Description Marked abnormalities were pre-defined as changes in lab tests after drug infusion and relative to normal range. Hemoglobin,11.6-14.8grams per deciliter(g/dL);Hematocrit,36.0-50.0 percent;Erythrocytes,3.80-5.10x10*6 cells per microliter(c/uL);Platelets,140-44 cells per liter(c/L);Leukocytes,4.00-12.50c/uL;Absolute(Abs)Neutrophils+Bands,<1.00x10^3 c/uL;Abs Lymphocytes,<0.72x10^3 or>7.50x10^3 c/uL;Abs Eosinophils,>0.750X10^3 c/uL;Alkaline Phosphatase,0-40 units per liter(U/L);Aspartate Aminotransferase,0-40 U/L;Alanine Aminotransferase,0-40U/L;G-Glutamyl Transferase,0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter(mg/dL);Blood Urea Nitrogen,5.9-26.0 mg/dL;Creatinine, 0.50-1.50mg/dL;Inorganic Phosphorus,2.8-6.2 U/L;Serum Potassium,3.5-5.5 milliequivalents per liter(mEq/L);Serum Glucose,65-99 mg/dL;Fasting Serum Glucose,65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin,3.5-5.5 g/dL;Urine Protein,>=4;Urine Glucose,>=4;Urine Blood,>=4;Urine Red Blood Cells>=4;Urine White Blood Cells,>=4.
Time Frame Period C (Day 282 to end of study)
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Hide Analysis Population Description
All treated participants in Period C evaluated for a specific analyte.
Arm/Group Title Abatacept (All Participants in Period C)
Hide Arm/Group Description:
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Overall Number of Participants Analyzed 153
Measure Type: Number
Unit of Measure: participants
Hemoglobin (Low) n=153 12
Hematocrit (Low) n=153 8
Erythrocytes (Low) n=153 4
Platelet Count (Low) n=153 4
Platelet Count (High) n=153 5
Leukocytes (Low) n=153 20
Leukocytes (High) n=153 18
Absolute Neutrophils + Bands (Low) 14
Absolute Lymphocytes (Low) n=153 21
Absolute Lymphocytes (High) n=153 5
Absolute Eosinophils (High) n=153 50
Alkaline Phosphatase (ALP, High) n=153 2
Aspartate Aminotransferase (AST, High) 5
Alanine Aminotransferase (ALT, High) n=153 11
G-Glutamyl Transferase (GGT, High) n=153 6
Bilirubin (Total, High) n=153 3
Blood Urea Nitrogen (High) n=153 15
Creatinine (High) n=153 36
Potassium (High) n=153 10
Inorganic Phosphorus (High) n=153 4
Serum Glucose (Low) n=153 54
Serum Glucose (High) n=153 1
Fasting Serum Glucose (Low) n=100 11
Fasting Serum Glucose (High) n=100 7
Total Protein (Low) n=153 1
Total Protein (High) n=153 1
Albumin (Low) n=153 9
Urine Protein (High) n=153 35
Urine Glucose (High) n=153 1
Urine Blood (High) n=153 73
Urine White Blood Cells (High) n=117 49
Urine Red Blood Cells (High) n=117 86
15.Secondary Outcome
Title Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)
Hide Description During Period C, blood samples for immunogenicity assessments were obtained just prior to the start of the IV infusion of abatacept at 3-month intervals during the first 2 years of Period C, at 6-month intervals thereafter, and again 28, 56, and 85 days after the last infusion. Direct-format, enzyme-linked immunosorbent assays (ELISAs) were used to evaluate the cytotoxic T-lymphocyte antigen 4 (CTLA4) and the anti-CTLA4-T antibody.
Time Frame Period C (Day 282 to 85 days after the last dose of study medication)
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Hide Analysis Population Description
All treated participants who were evaluated for immunogenicity during Period C
Arm/Group Title Abatacept (Period A Non-Responders in Period C) Abatacept (Period C) Placebo (Period B) to Abatacept (Period C)
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Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Overall Number of Participants Analyzed 33 57 58
Measure Type: Number
Unit of Measure: participants
Anti-Abatacept, Overall on Treatment (n=31,54,54) 1 5 2
Anti-Abatacept, Post-Treatment (n=25,41,38) 0 3 3
Anti-CTLA4-T, Overall on Treatment (n=33,57,58) 4 4 4
Anti-CTLA4-T, Overall Post-Treatment (n=27,46,42) 4 1 1
Time Frame From first dose to last dose plus 56 days up to end of study (November 2011)
Adverse Event Reporting Description Study initiated: February 2004; Study completed: November 2011
 
Arm/Group Title Abatacept (Only Period A) Abatacept (Period A/Period C) Abatacept (Period A/Period B) Abatacept (Period A)/Placebo (Period B)
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Participants treated in Period A but did not in Periods B or C.

Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.

Participants treated in Period A, not eligible to continue into Period B, but re-entered in Period C.

Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).

All participants treated with Abatacept in Periods A and B who may or may not have entered Period C.

Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses, then once a month for 6 months. If participants entered Period C, treatment continued once a month for up to 5 years.

All participants treated with Abatacept in Period A, placebo in Period B, who may or may not have entered Period C.

Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion. If participants entered Period C, they were treated with Abatacept,10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.

All-Cause Mortality
Abatacept (Only Period A) Abatacept (Period A/Period C) Abatacept (Period A/Period B) Abatacept (Period A)/Placebo (Period B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept (Only Period A) Abatacept (Period A/Period C) Abatacept (Period A/Period B) Abatacept (Period A)/Placebo (Period B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/32 (12.50%)   10/36 (27.78%)   9/60 (15.00%)   14/62 (22.58%) 
Gastrointestinal disorders         
Abdominal pain  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  0/62 (0.00%) 
Vomiting  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  1/62 (1.61%) 
Nausea  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
General disorders         
Fatigue  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Condition aggravated  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Pyrexia  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  1/62 (1.61%) 
Immune system disorders         
Food allergy  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Hypersensitivity  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  0/62 (0.00%) 
Infections and infestations         
Erysipelas  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Abscess limb  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Appendicitis  1  0/32 (0.00%)  0/36 (0.00%)  2/60 (3.33%)  0/62 (0.00%) 
Gastroenteritis  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Herpes zoster  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Meningitis bacterial  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Tooth abscess  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  0/62 (0.00%) 
Arthritis bacterial  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  1/62 (1.61%) 
Dengue fever  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Pyelonephritis  1  0/32 (0.00%)  1/36 (2.78%)  1/60 (1.67%)  0/62 (0.00%) 
Varicella  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  1/62 (1.61%) 
Injury, poisoning and procedural complications         
Joint dislocation  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Overdose  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  0/62 (0.00%) 
Multiple injuries  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Metabolism and nutrition disorders         
Type 1 diabetes mellitus  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/32 (0.00%)  3/36 (8.33%)  3/60 (5.00%)  0/62 (0.00%) 
Foot deformity  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  1/62 (1.61%) 
Rheumatoid arthritis  1  2/32 (6.25%)  1/36 (2.78%)  0/60 (0.00%)  1/62 (1.61%) 
Torticollis  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Arthralgia  1  0/32 (0.00%)  1/36 (2.78%)  1/60 (1.67%)  1/62 (1.61%) 
Arthropathy  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Juvenile arthritis  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Synovial cyst  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Fibroadenoma of breast  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  0/62 (0.00%) 
Acute lymphocytic leukaemia  1  1/32 (3.13%)  0/36 (0.00%)  0/60 (0.00%)  0/62 (0.00%) 
Nervous system disorders         
Encephalitis  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Temporal lobe epilepsy  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Multiple sclerosis  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Psychiatric disorders         
Suicide attempt  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Reproductive system and breast disorders         
Ovarian cyst  1  1/32 (3.13%)  0/36 (0.00%)  0/60 (0.00%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders         
Skin ulcer  1  0/32 (0.00%)  1/36 (2.78%)  0/60 (0.00%)  0/62 (0.00%) 
Vascular disorders         
Haematoma  1  0/32 (0.00%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept (Only Period A) Abatacept (Period A/Period C) Abatacept (Period A/Period B) Abatacept (Period A)/Placebo (Period B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/32 (68.75%)   32/36 (88.89%)   57/60 (95.00%)   54/62 (87.10%) 
Blood and lymphatic system disorders         
Anaemia  1  0/32 (0.00%)  2/36 (5.56%)  3/60 (5.00%)  5/62 (8.06%) 
Leukopenia  1  0/32 (0.00%)  3/36 (8.33%)  4/60 (6.67%)  3/62 (4.84%) 
Eosinophilia  1  0/32 (0.00%)  4/36 (11.11%)  5/60 (8.33%)  6/62 (9.68%) 
Ear and labyrinth disorders         
Ear pain  1  0/32 (0.00%)  0/36 (0.00%)  1/60 (1.67%)  4/62 (6.45%) 
Eye disorders         
Cataract  1  0/32 (0.00%)  2/36 (5.56%)  1/60 (1.67%)  0/62 (0.00%) 
Conjunctivitis allergic  1  0/32 (0.00%)  0/36 (0.00%)  4/60 (6.67%)  0/62 (0.00%) 
Conjunctivitis  1  0/32 (0.00%)  4/36 (11.11%)  5/60 (8.33%)  4/62 (6.45%) 
Gastrointestinal disorders         
Diarrhoea  1  2/32 (6.25%)  8/36 (22.22%)  11/60 (18.33%)  15/62 (24.19%) 
Mouth ulceration  1  2/32 (6.25%)  1/36 (2.78%)  3/60 (5.00%)  4/62 (6.45%) 
Abdominal discomfort  1  0/32 (0.00%)  2/36 (5.56%)  2/60 (3.33%)  0/62 (0.00%) 
Abdominal pain  1  1/32 (3.13%)  6/36 (16.67%)  8/60 (13.33%)  8/62 (12.90%) 
Abdominal pain upper  1  0/32 (0.00%)  5/36 (13.89%)  10/60 (16.67%)  10/62 (16.13%) 
Duodenitis  1  0/32 (0.00%)  2/36 (5.56%)  0/60 (0.00%)  0/62 (0.00%) 
Gastritis  1  0/32 (0.00%)  6/36 (16.67%)  6/60 (10.00%)  5/62 (8.06%) 
Vomiting  1  2/32 (6.25%)  7/36 (19.44%)  9/60 (15.00%)  13/62 (20.97%) 
Aphthous stomatitis  1  1/32 (3.13%)  3/36 (8.33%)  3/60 (5.00%)  2/62 (3.23%) 
Dyspepsia  1  0/32 (0.00%)  1/36 (2.78%)  4/60 (6.67%)  3/62 (4.84%) 
Nausea  1  6/32 (18.75%)  5/36 (13.89%)  9/60 (15.00%)  12/62 (19.35%) 
General disorders         
Fatigue  1  2/32 (6.25%)  2/36 (5.56%)  0/60 (0.00%)  1/62 (1.61%) 
Chest pain  1  0/32 (0.00%)  2/36 (5.56%)  2/60 (3.33%)  2/62 (3.23%) 
Pain  1  1/32 (3.13%)  2/36 (5.56%)  0/60 (0.00%)  2/62 (3.23%) 
Chills  1  0/32 (0.00%)  0/36 (0.00%)  3/60 (5.00%)  1/62 (1.61%) 
Influenza like illness  1  0/32 (0.00%)  0/36 (0.00%)  3/60 (5.00%)  4/62 (6.45%) 
Pyrexia  1  2/32 (6.25%)  8/36 (22.22%)  12/60 (20.00%)  12/62 (19.35%) 
Infections and infestations         
Pneumonia  1  0/32 (0.00%)  2/36 (5.56%)  0/60 (0.00%)  0/62 (0.00%) 
Bacteriuria  1  0/32 (0.00%)  2/36 (5.56%)  6/60 (10.00%)  2/62 (3.23%) 
Pharyngitis streptococcal  1  2/32 (6.25%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Pharyngotonsillitis  1  0/32 (0.00%)  2/36 (5.56%)  3/60 (5.00%)  1/62 (1.61%) 
Vulvovaginitis  1  0/32 (0.00%)  4/36 (11.11%)  1/60 (1.67%)  2/62 (3.23%) 
Fungal skin infection  1  0/32 (0.00%)  3/36 (8.33%)  3/60 (5.00%)  2/62 (3.23%) 
Impetigo  1  0/32 (0.00%)  3/36 (8.33%)  2/60 (3.33%)  2/62 (3.23%) 
Pneumonia primary atypical  1  0/32 (0.00%)  2/36 (5.56%)  0/60 (0.00%)  0/62 (0.00%) 
Rhinitis  1  0/32 (0.00%)  6/36 (16.67%)  8/60 (13.33%)  9/62 (14.52%) 
Gastroenteritis  1  1/32 (3.13%)  4/36 (11.11%)  6/60 (10.00%)  5/62 (8.06%) 
Tonsillitis  1  0/32 (0.00%)  6/36 (16.67%)  7/60 (11.67%)  3/62 (4.84%) 
Upper respiratory tract infection  1  3/32 (9.38%)  12/36 (33.33%)  11/60 (18.33%)  12/62 (19.35%) 
Urinary tract infection  1  0/32 (0.00%)  2/36 (5.56%)  10/60 (16.67%)  3/62 (4.84%) 
Lice infestation  1  0/32 (0.00%)  2/36 (5.56%)  3/60 (5.00%)  0/62 (0.00%) 
Pharyngitis  1  0/32 (0.00%)  3/36 (8.33%)  10/60 (16.67%)  13/62 (20.97%) 
Nasopharyngitis  1  3/32 (9.38%)  11/36 (30.56%)  20/60 (33.33%)  15/62 (24.19%) 
Sinusitis  1  1/32 (3.13%)  5/36 (13.89%)  12/60 (20.00%)  7/62 (11.29%) 
Paronychia  1  2/32 (6.25%)  3/36 (8.33%)  3/60 (5.00%)  2/62 (3.23%) 
Tinea versicolour  1  0/32 (0.00%)  1/36 (2.78%)  3/60 (5.00%)  1/62 (1.61%) 
Varicella  1  0/32 (0.00%)  1/36 (2.78%)  3/60 (5.00%)  3/62 (4.84%) 
Viral infection  1  3/32 (9.38%)  0/36 (0.00%)  2/60 (3.33%)  4/62 (6.45%) 
Bronchitis  1  0/32 (0.00%)  2/36 (5.56%)  8/60 (13.33%)  4/62 (6.45%) 
Influenza  1  1/32 (3.13%)  6/36 (16.67%)  16/60 (26.67%)  12/62 (19.35%) 
Otitis media acute  1  0/32 (0.00%)  2/36 (5.56%)  1/60 (1.67%)  3/62 (4.84%) 
Injury, poisoning and procedural complications         
Joint injury  1  0/32 (0.00%)  1/36 (2.78%)  1/60 (1.67%)  5/62 (8.06%) 
Arthropod bite  1  0/32 (0.00%)  2/36 (5.56%)  0/60 (0.00%)  2/62 (3.23%) 
Fall  1  0/32 (0.00%)  0/36 (0.00%)  2/60 (3.33%)  5/62 (8.06%) 
Investigations         
Alanine aminotransferase increased  1  0/32 (0.00%)  0/36 (0.00%)  5/60 (8.33%)  2/62 (3.23%) 
Transaminases increased  1  0/32 (0.00%)  1/36 (2.78%)  3/60 (5.00%)  1/62 (1.61%) 
Aspartate aminotransferase increased  1  0/32 (0.00%)  0/36 (0.00%)  3/60 (5.00%)  2/62 (3.23%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/32 (0.00%)  2/36 (5.56%)  3/60 (5.00%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/32 (0.00%)  0/36 (0.00%)  3/60 (5.00%)  4/62 (6.45%) 
Torticollis  1  0/32 (0.00%)  2/36 (5.56%)  1/60 (1.67%)  0/62 (0.00%) 
Arthralgia  1  0/32 (0.00%)  1/36 (2.78%)  1/60 (1.67%)  4/62 (6.45%) 
Back pain  1  0/32 (0.00%)  3/36 (8.33%)  5/60 (8.33%)  2/62 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma  1  1/32 (3.13%)  0/36 (0.00%)  3/60 (5.00%)  4/62 (6.45%) 
Nervous system disorders         
Dizziness  1  4/32 (12.50%)  3/36 (8.33%)  7/60 (11.67%)  4/62 (6.45%) 
Headache  1  7/32 (21.88%)  10/36 (27.78%)  14/60 (23.33%)  11/62 (17.74%) 
Psychiatric disorders         
Insomnia  1  2/32 (6.25%)  0/36 (0.00%)  0/60 (0.00%)  1/62 (1.61%) 
Renal and urinary disorders         
Haematuria  1  0/32 (0.00%)  2/36 (5.56%)  5/60 (8.33%)  4/62 (6.45%) 
Dysuria  1  0/32 (0.00%)  0/36 (0.00%)  4/60 (6.67%)  4/62 (6.45%) 
Leukocyturia  1  0/32 (0.00%)  2/36 (5.56%)  1/60 (1.67%)  0/62 (0.00%) 
Reproductive system and breast disorders         
Vaginal discharge  1  0/32 (0.00%)  2/36 (5.56%)  1/60 (1.67%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  4/32 (12.50%)  3/36 (8.33%)  8/60 (13.33%)  8/62 (12.90%) 
Rhinitis allergic  1  2/32 (6.25%)  1/36 (2.78%)  4/60 (6.67%)  2/62 (3.23%) 
Cough  1  4/32 (12.50%)  7/36 (19.44%)  10/60 (16.67%)  13/62 (20.97%) 
Epistaxis  1  2/32 (6.25%)  2/36 (5.56%)  0/60 (0.00%)  0/62 (0.00%) 
Nasal congestion  1  2/32 (6.25%)  0/36 (0.00%)  1/60 (1.67%)  1/62 (1.61%) 
Dyspnoea  1  0/32 (0.00%)  2/36 (5.56%)  0/60 (0.00%)  0/62 (0.00%) 
Rhinorrhoea  1  0/32 (0.00%)  2/36 (5.56%)  3/60 (5.00%)  2/62 (3.23%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  1/32 (3.13%)  2/36 (5.56%)  2/60 (3.33%)  1/62 (1.61%) 
Eczema  1  2/32 (6.25%)  0/36 (0.00%)  2/60 (3.33%)  4/62 (6.45%) 
Rash  1  0/32 (0.00%)  1/36 (2.78%)  3/60 (5.00%)  5/62 (8.06%) 
Dermatitis  1  0/32 (0.00%)  1/36 (2.78%)  3/60 (5.00%)  0/62 (0.00%) 
Vascular disorders         
Hypertension  1  0/32 (0.00%)  2/36 (5.56%)  2/60 (3.33%)  0/62 (0.00%) 
Flushing  1  2/32 (6.25%)  0/36 (0.00%)  0/60 (0.00%)  0/62 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00095173     History of Changes
Other Study ID Numbers: IM101-033
First Submitted: November 1, 2004
First Posted: November 2, 2004
Results First Submitted: September 22, 2016
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017