Trial Outcomes & Findings for BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis (NCT NCT00095173)
NCT ID: NCT00095173
Last Updated: 2017-01-18
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
Period B (Day 113 to Day 282)
Results posted on
2017-01-18
Participant Flow
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.
Participant milestones
| Measure |
Abatacept (All Participants in Period A)
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 (Period B)
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 (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.
|
Abatacept (Period A Non-Responders in Period C)
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 (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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|---|---|---|
|
Open-Label Lead-In Phase (Period A)
STARTED
|
190
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Lead-In Phase (Period A)
COMPLETED
|
170
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Lead-In Phase (Period A)
NOT COMPLETED
|
20
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase (Period B)
STARTED
|
0
|
60
|
62
|
0
|
0
|
0
|
|
Double-Blind Phase (Period B)
COMPLETED
|
0
|
49
|
31
|
0
|
0
|
0
|
|
Double-Blind Phase (Period B)
NOT COMPLETED
|
0
|
11
|
31
|
0
|
0
|
0
|
|
Open-Label Extension Phase (Period C)
STARTED
|
0
|
0
|
0
|
36
|
58
|
59
|
|
Open-Label Extension Phase (Period C)
COMPLETED
|
0
|
0
|
0
|
13
|
29
|
27
|
|
Open-Label Extension Phase (Period C)
NOT COMPLETED
|
0
|
0
|
0
|
23
|
29
|
32
|
Reasons for withdrawal
| Measure |
Abatacept (All Participants in Period A)
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 (Period B)
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 (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.
|
Abatacept (Period A Non-Responders in Period C)
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 (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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|---|---|---|
|
Open-Label Lead-In Phase (Period A)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Lead-In Phase (Period A)
Lack of Efficacy
|
17
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Lead-In Phase (Period A)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Lead-In Phase (Period A)
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase (Period B)
Lack of Efficacy
|
0
|
10
|
31
|
0
|
0
|
0
|
|
Double-Blind Phase (Period B)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-Label Extension Phase (Period C)
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Extension Phase (Period C)
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
3
|
|
Open-Label Extension Phase (Period C)
Lack of Efficacy
|
0
|
0
|
0
|
11
|
5
|
8
|
|
Open-Label Extension Phase (Period C)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
5
|
6
|
|
Open-Label Extension Phase (Period C)
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
6
|
0
|
|
Open-Label Extension Phase (Period C)
No Longer Meets Study Criteria
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Open-Label Extension Phase (Period C)
Poor/Non-Compliance
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Open-Label Extension Phase (Period C)
Pregnancy
|
0
|
0
|
0
|
1
|
2
|
3
|
|
Open-Label Extension Phase (Period C)
Other
|
0
|
0
|
0
|
4
|
6
|
8
|
Baseline Characteristics
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Abatacept (All Participants in Period A)
n=190 Participants
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.
|
|---|---|
|
Age, Continuous
|
13.0 years
n=5 Participants
|
|
Gender
Female
|
137 Participants
n=5 Participants
|
|
Gender
Male
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period B (Day 113 to Day 282)Population: All treated participants
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)
Outcome measures
| Measure |
Abatacept (Period B)
n=60 Participants
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 (Period B)
n=62 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)
|
NA months
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.
|
6 months
Interval 0.73 to 6.87
|
—
|
SECONDARY outcome
Timeframe: Period B (Day 113 to Day 282)Population: All treated participants
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)
Outcome measures
| Measure |
Abatacept (Period B)
n=60 Participants
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 (Period B)
n=62 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)
|
12 participants
|
33 participants
|
—
|
SECONDARY outcome
Timeframe: Period A (Day 1 to Day 113)Population: All treated participants in Periods A
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).
Outcome measures
| Measure |
Abatacept (Period B)
n=190 Participants
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 (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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
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)
SAE
|
6 participants
|
—
|
—
|
|
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)
Treatment-Related AE
|
0 participants
|
—
|
—
|
|
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)
All Deaths
|
0 participants
|
—
|
—
|
|
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)
Treatment-Related Deaths
|
0 participants
|
—
|
—
|
|
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)
Discontinuation of Study Drug due to AEs
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Period B (Day 113 to Day 282)Population: All treated participants in Periods B
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).
Outcome measures
| Measure |
Abatacept (Period B)
n=60 Participants
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 (Period B)
n=62 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
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)
SAE
|
0 participants
|
2 participants
|
—
|
|
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)
Treatment-Related AE
|
0 participants
|
0 participants
|
—
|
|
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)
All Deaths
|
0 participants
|
0 participants
|
—
|
|
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)
Treatment-Related Deaths
|
0 participants
|
0 participants
|
—
|
|
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)
Discontinuation of Study Drug due to AEs
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Period C (Day 282 to end of study)Population: All treated participants in Period C
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).
Outcome measures
| Measure |
Abatacept (Period B)
n=36 Participants
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 (Period B)
n=58 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
n=59 Participants
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.
|
|---|---|---|---|
|
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)
SAE
|
9 participants
|
9 participants
|
12 participants
|
|
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)
Treatment-Related AE
|
2 participants
|
4 participants
|
3 participants
|
|
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)
All Deaths
|
0 participants
|
0 participants
|
1 participants
|
|
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)
Treatment-Related Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
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)
Discontinuation of Study Drug due to AEs
|
1 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Period B (Day 113 to Day 282)Population: All treated participants in Period B
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=60 Participants
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 (Period B)
n=62 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
Active Joints
|
-20.9 percentage change from baseline
Interval -92.0 to 17.86
|
50.00 percentage change from baseline
Interval 0.0 to 100.0
|
—
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
Joints with LOM
|
0.00 percentage change from baseline
Interval -45.5 to 0.0
|
50.00 percentage change from baseline
Interval 0.0 to 100.0
|
—
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
Physician Global Assessment
|
-29.8 percentage change from baseline
Interval -86.3 to 22.48
|
55.95 percentage change from baseline
Interval -31.3 to 250.0
|
—
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
Parent Global Assessment
|
-11.2 percentage change from baseline
Interval -56.8 to 28.41
|
8.39 percentage change from baseline
Interval -31.8 to 100.0
|
—
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
CHAQ Disability Index
|
0.00 percentage change from baseline
Interval -38.9 to 2.17
|
0.00 percentage change from baseline
Interval -13.3 to 55.56
|
—
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
ESR
|
0.00 percentage change from baseline
Interval -20.7 to 50.0
|
20.50 percentage change from baseline
Interval -14.3 to 92.0
|
—
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)
CRP
|
0.00 percentage change from baseline
Interval -46.6 to 67.0
|
6.25 percentage change from baseline
Interval -33.3 to 150.0
|
—
|
SECONDARY outcome
Timeframe: Period C (Day 282 to end of study)Population: All treated participants in Period C
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=36 Participants
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 (Period B)
n=58 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
n=59 Participants
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.
|
|---|---|---|---|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
CHAQ Disability Index
|
14.14 percentage change from baseline
Interval -16.7 to 100.0
|
-56.7 percentage change from baseline
Interval -81.8 to -18.2
|
-45.5 percentage change from baseline
Interval -75.0 to -12.5
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
Parent Global Assessment of Overall Well-Being
|
1.96 percentage change from baseline
Interval -19.6 to 26.67
|
-62.7 percentage change from baseline
Interval -93.8 to -27.5
|
-63.9 percentage change from baseline
Interval -84.2 to -38.8
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
ESR
|
20.87 percentage change from baseline
Interval -15.5 to 83.77
|
-27.3 percentage change from baseline
Interval -54.8 to 20.0
|
-24.2 percentage change from baseline
Interval -50.0 to 0.0
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
CRP
|
0.00 percentage change from baseline
Interval -31.6 to 43.68
|
-33.8 percentage change from baseline
Interval -84.4 to 54.84
|
-27.8 percentage change from baseline
Interval -75.0 to 11.11
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
Active Joints
|
-26.7 percentage change from baseline
Interval -66.7 to 0.0
|
-70.2 percentage change from baseline
Interval -94.1 to -50.0
|
-82.4 percentage change from baseline
Interval -100.0 to -62.5
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
Joints with Limited Range of Motion
|
0.00 percentage change from baseline
Interval -33.3 to 36.67
|
-50.0 percentage change from baseline
Interval -75.0 to -27.3
|
-71.4 percentage change from baseline
Interval -86.2 to -23.1
|
|
Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)
Physician Global Assessment of Disease Severity
|
-31.9 percentage change from baseline
Interval -50.0 to -9.33
|
-75.0 percentage change from baseline
Interval -91.3 to -52.3
|
-81.8 percentage change from baseline
Interval -91.4 to -64.3
|
SECONDARY outcome
Timeframe: Period A (Day 1 to Day 113)Population: All treated participants in Period A
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=190 Participants
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 (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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Infections and Infestations
|
68 participants
|
—
|
—
|
|
Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Peri-Infusional AEs
|
30 participants
|
—
|
—
|
|
Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Autoimmune Disorders
|
2 participants
|
—
|
—
|
|
Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Malignancies
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Period B (Day 113 to Day 282)Population: All treated participants in Period B
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=60 Participants
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 (Period B)
n=62 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Infections and Infestations
|
27 participants
|
27 participants
|
—
|
|
Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Peri-Infusional AEs
|
2 participants
|
2 participants
|
—
|
|
Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Autoimmune Disorders
|
0 participants
|
0 participants
|
—
|
|
Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Malignancies
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Period C (Day 282 up to 56 days after the last dose of study medication)Population: All treated participants in Period C
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=153 Participants
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 (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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Infections and Infestations
|
120 participants
|
—
|
—
|
|
Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Peri-Infusional AEs
|
22 participants
|
—
|
—
|
|
Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Autoimmune Disorders
|
7 participants
|
—
|
—
|
|
Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies
Malignancies
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 113, Day 282, and Day 2047Population: All treated participants
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=36 Participants
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 (Period B)
n=58 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
n=59 Participants
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.
|
|---|---|---|---|
|
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
ACR Pediatric 30 (ESR) at Day 113
|
0 percentage of participants
No participants with response
|
100 percentage of participants
Confidence interval not applicable if result is 100%
|
100 percentage of participants
Confidence interval not applicable if result is 100%
|
|
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
ACR Pediatric 30 (ESR) at Day 282
|
NA percentage of participants
No participants in this group
|
84.5 percentage of participants
Interval 75.2 to 93.8
|
67.8 percentage of participants
Interval 55.9 to 79.7
|
|
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
ACR Pediatric 30 (ESR) at Day 2047
|
69.2 percentage of participants
Interval 44.1 to 94.3
|
97.0 percentage of participants
Interval 91.1 to 100.0
|
86.7 percentage of participants
Interval 74.5 to 98.8
|
|
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
ACR Pediatric 50 (ESR) at Day 113
|
0 percentage of participants
No participants with response
|
65.5 percentage of participants
Interval 53.3 to 77.7
|
88.1 percentage of participants
Interval 79.9 to 96.4
|
|
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
ACR Pediatric 50 (ESR) at Day 282
|
NA percentage of participants
No participants in this group
|
79.3 percentage of participants
Interval 68.9 to 89.7
|
52.5 percentage of participants
Interval 39.8 to 65.3
|
|
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
ACR Pediatric 50 (ESR) at Day 2047
|
69.2 percentage of participants
Interval 44.1 to 94.3
|
93.9 percentage of participants
Interval 85.8 to 100.0
|
80.0 percentage of participants
Interval 65.7 to 94.3
|
|
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
ACR Pediatric 70 (ESR) at Day 113
|
0 percentage of participants
No participants with response
|
37.9 percentage of participants
Interval 25.4 to 50.4
|
49.2 percentage of participants
Interval 36.4 to 61.9
|
|
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
ACR Pediatric 70 (ESR) at Day 282
|
NA percentage of participants
No participants in this group
|
55.2 percentage of participants
Interval 42.4 to 68.0
|
30.5 percentage of participants
Interval 18.8 to 42.3
|
|
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
ACR Pediatric 70 (ESR) at Day 2047
|
53.8 percentage of participants
Interval 26.7 to 80.9
|
78.8 percentage of participants
Interval 64.8 to 92.7
|
63.3 percentage of participants
Interval 46.1 to 80.6
|
|
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
ACR Pediatric 90 (ESR) at Day 113
|
0 percentage of participants
No participants with response
|
17.2 percentage of participants
Interval 7.5 to 27.0
|
22.0 percentage of participants
Interval 11.5 to 32.6
|
|
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
ACR Pediatric 90 (ESR) at Day 282
|
NA percentage of participants
No participants in this group
|
41.4 percentage of participants
Interval 28.7 to 54.1
|
15.3 percentage of participants
Interval 6.1 to 24.4
|
|
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
ACR Pediatric 90 (ESR) at Day 2047
|
38.5 percentage of participants
Interval 12.0 to 64.9
|
66.7 percentage of participants
Interval 50.6 to 82.8
|
40.0 percentage of participants
Interval 22.5 to 57.5
|
SECONDARY outcome
Timeframe: Period A (Day 1 to Day 113)Population: All treated participants in Period C evaluated for a specific analyte.
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=190 Participants
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 (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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Hemoglobin (Low) n=189
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Hematocrit (Low) n=189
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Erythrocytes (Low) n=189
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Platelets (Low) n=189
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Platelet Count (High) n=189
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Leukocytes (Low) n=189
|
9 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Leukocytes (High) n=189
|
10 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Absolute Neutrophils + Bands (Low) n=189
|
5 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Absolute Lymphocytes (Low) n=189
|
9 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Absolute Eosinophils (High) n=189
|
16 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Alanine Aminotransferase (ALT, High) n=190
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
G-Glutamyl Transferase (GGT, High) n=190
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Bilirubin (Total, High) n=190
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Blood Urea Nitrogen (High) n=190
|
6 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Creatinine (High) n=190
|
12 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Potassium (High) n=190
|
4 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Serum Glucose (Low) n=190
|
26 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Serum Glucose (High) n=190
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Fasting Serum Glucose (High) n=109
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Total Protein (High) n=190
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Albumin (Low) n=190
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Urine Protein (High) n=190
|
12 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Urine Glucose (High) n=190
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Urine Blood (High) n=190
|
23 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Urine White Blood Cells (High) n=75
|
9 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)
Urine Red Blood Cells (High) n=75
|
25 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Period B (Day 113 to Day 282)Population: All treated participants in Period B evaluated for a specific analyte.
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=60 Participants
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 (Period B)
n=62 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Hemoglobin (Low) n=60, 61
|
1 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Hematocrit (Low) n=60, 61
|
1 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Erythrocytes (Low) n=60, 61
|
0 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Platelets (Low) n-60, 61
|
4 participants
|
0 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Platelets (High) n=189
|
0 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Leukocytes (Low) n=60, 61
|
1 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Leukocytes (High) n=60, 61
|
1 participants
|
2 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Absolute Neutrophils + Bands (Low) n=60, 62
|
0 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Absolute Lymphocytes (Low) n=60, 62
|
2 participants
|
3 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Absolute Eosinophils (High) n=60, 62
|
6 participants
|
4 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Aspartate Aminotransferase (AST, High) n=60, 62
|
1 participants
|
0 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Alanine Aminotransferase (ALT, High) n=60, 62
|
1 participants
|
0 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Blood Urea Nitrogen (High) n=60, 62
|
1 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Serum Sodium (Low) n=60, 62
|
0 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Serum Potassium (High) n=60, 62
|
2 participants
|
0 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Serum Glucose (Low) n=60, 62
|
4 participants
|
5 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Serum Glucose (High) n=60, 62
|
0 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Fasting Serum Glucose (High) n=60, 62
|
1 participants
|
1 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Urine Protein (High) n=62
|
2 participants
|
2 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Urine Blood (High) n=60, 62
|
12 participants
|
6 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Urine White Blood Cells (High) n=24, 20
|
5 participants
|
2 participants
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)
Urine Red Blood Cells (High) n=24, 20
|
6 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: Period C (Day 282 to end of study)Population: All treated participants in Period C evaluated for a specific analyte.
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=153 Participants
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 (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.
|
Placebo (Period B) to Abatacept (Period C)
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.
|
|---|---|---|---|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Hemoglobin (Low) n=153
|
12 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Hematocrit (Low) n=153
|
8 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Erythrocytes (Low) n=153
|
4 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Platelet Count (Low) n=153
|
4 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Platelet Count (High) n=153
|
5 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Leukocytes (Low) n=153
|
20 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Leukocytes (High) n=153
|
18 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Absolute Neutrophils + Bands (Low)
|
14 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Absolute Lymphocytes (Low) n=153
|
21 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Absolute Lymphocytes (High) n=153
|
5 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Absolute Eosinophils (High) n=153
|
50 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Alkaline Phosphatase (ALP, High) n=153
|
2 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Aspartate Aminotransferase (AST, High)
|
5 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Alanine Aminotransferase (ALT, High) n=153
|
11 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
G-Glutamyl Transferase (GGT, High) n=153
|
6 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Bilirubin (Total, High) n=153
|
3 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Blood Urea Nitrogen (High) n=153
|
15 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Creatinine (High) n=153
|
36 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Potassium (High) n=153
|
10 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Inorganic Phosphorus (High) n=153
|
4 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Serum Glucose (Low) n=153
|
54 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Serum Glucose (High) n=153
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Fasting Serum Glucose (Low) n=100
|
11 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Fasting Serum Glucose (High) n=100
|
7 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Total Protein (Low) n=153
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Total Protein (High) n=153
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Albumin (Low) n=153
|
9 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Urine Protein (High) n=153
|
35 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Urine Glucose (High) n=153
|
1 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Urine Blood (High) n=153
|
73 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Urine White Blood Cells (High) n=117
|
49 participants
|
—
|
—
|
|
Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)
Urine Red Blood Cells (High) n=117
|
86 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Period C (Day 282 to 85 days after the last dose of study medication)Population: All treated participants who were evaluated for immunogenicity during Period C
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.
Outcome measures
| Measure |
Abatacept (Period B)
n=33 Participants
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 (Period B)
n=57 Participants
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.
|
Placebo (Period B) to Abatacept (Period C)
n=58 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)
Anti-Abatacept, Overall on Treatment (n=31,54,54)
|
1 participants
|
5 participants
|
2 participants
|
|
Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)
Anti-Abatacept, Post-Treatment (n=25,41,38)
|
0 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)
Anti-CTLA4-T, Overall on Treatment (n=33,57,58)
|
4 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)
Anti-CTLA4-T, Overall Post-Treatment (n=27,46,42)
|
4 participants
|
1 participants
|
1 participants
|
Adverse Events
Abatacept (Only Period A)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Abatacept (Period A/Period C)
Serious events: 10 serious events
Other events: 32 other events
Deaths: 0 deaths
Abatacept (Period A/Period B)
Serious events: 9 serious events
Other events: 57 other events
Deaths: 0 deaths
Abatacept (Period A)/Placebo (Period B)
Serious events: 14 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abatacept (Only Period A)
n=32 participants at risk
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.
|
Abatacept (Period A/Period C)
n=36 participants at risk
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).
|
Abatacept (Period A/Period B)
n=60 participants at risk
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.
|
Abatacept (Period A)/Placebo (Period B)
n=62 participants at risk
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.
|
|---|---|---|---|---|
|
Infections and infestations
Erysipelas
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Fatigue
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Vascular disorders
Haematoma
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Reproductive system and breast disorders
Ovarian cyst
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Abscess limb
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Appendicitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Condition aggravated
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Immune system disorders
Food allergy
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Dengue fever
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Varicella
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Juvenile arthritis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Pyrexia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
Other adverse events
| Measure |
Abatacept (Only Period A)
n=32 participants at risk
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.
|
Abatacept (Period A/Period C)
n=36 participants at risk
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).
|
Abatacept (Period A/Period B)
n=60 participants at risk
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.
|
Abatacept (Period A)/Placebo (Period B)
n=62 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.1%
5/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Fatigue
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
10.0%
6/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
22.2%
8/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
18.3%
11/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
24.2%
15/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
5/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
4/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
13.3%
8/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
12.9%
8/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.7%
4/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
11.1%
4/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Eye disorders
Cataract
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Chest pain
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.7%
4/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
4/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
19.4%
7/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
10/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
21.0%
13/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Impetigo
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Pain
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Rhinitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
6/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
13.3%
8/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
14.5%
9/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
11.7%
7/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.7%
4/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Vascular disorders
Flushing
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Gastroenteritis
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
11.1%
4/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
10.0%
6/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.1%
5/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.7%
4/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
4.8%
3/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.1%
5/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
6/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
11.7%
7/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
4.8%
3/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
3/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
33.3%
12/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
18.3%
11/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
19.4%
12/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
10/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
4.8%
3/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
6/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
13.3%
8/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
12.9%
8/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
13.9%
5/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
10/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.1%
10/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
5/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
11.1%
4/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
5/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
9.7%
6/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Lice infestation
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
10/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
21.0%
13/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Investigations
Transaminases increased
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
6/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
10.0%
6/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.1%
5/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Nervous system disorders
Headache
|
21.9%
7/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
27.8%
10/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
23.3%
14/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
17.7%
11/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
3/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
30.6%
11/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
33.3%
20/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
24.2%
15/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
13.9%
5/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
20.0%
12/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
11.3%
7/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
19.4%
7/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
15.0%
9/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
21.0%
13/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
11.1%
4/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
5/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.7%
4/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
4.8%
3/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.1%
5/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Paronychia
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Varicella
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
2.8%
1/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
4.8%
3/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Viral infection
|
9.4%
3/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
3/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.3%
5/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.2%
2/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Bronchitis
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
13.3%
8/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Chills
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
3.3%
2/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
8.1%
5/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Influenza
|
3.1%
1/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
16.7%
6/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
26.7%
16/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
19.4%
12/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Influenza like illness
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
0.00%
0/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.0%
3/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
6.5%
4/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Gastrointestinal disorders
Nausea
|
18.8%
6/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
13.9%
5/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
15.0%
9/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
19.4%
12/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
4.8%
3/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
General disorders
Pyrexia
|
6.2%
2/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
22.2%
8/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
20.0%
12/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
19.4%
12/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/32 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
5.6%
2/36 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.7%
1/60 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
1.6%
1/62 • From first dose to last dose plus 56 days up to end of study (November 2011)
Study initiated: February 2004; Study completed: November 2011
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60