Trial Outcomes & Findings for Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis (NCT NCT01714817)
NCT ID: NCT01714817
Last Updated: 2021-02-26
Results Overview
Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no \<85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR\<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no \>10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with \>10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
695 participants
Primary outcome timeframe
Day 365
Results posted on
2021-02-26
Participant Flow
Overall, 695 participants were enrolled; 406 randomized; and 405 received treatment. 289 participants were screen failures and never treated with study medication; 233 were due to no longer meeting study criteria; 19 withdrew consent; 4 due to Adverse Events; 1 due to death; 1 due to poor/non-compliance; 1 was lost to follow up; and 30 were other.
Participant milestones
| Measure |
Abatacept IV
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
|
Placebo IV
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
|
|---|---|---|
|
Year 1 Period
STARTED
|
203
|
203
|
|
Year 1 Period
Treated
|
202
|
203
|
|
Year 1 Period
COMPLETED
|
155
|
161
|
|
Year 1 Period
NOT COMPLETED
|
48
|
42
|
|
Year 2 Period
STARTED
|
155
|
161
|
|
Year 2 Period
COMPLETED
|
129
|
123
|
|
Year 2 Period
NOT COMPLETED
|
26
|
38
|
|
Long-Term Extension (LTE) Period
STARTED
|
129
|
123
|
|
Long-Term Extension (LTE) Period
COMPLETED
|
62
|
53
|
|
Long-Term Extension (LTE) Period
NOT COMPLETED
|
67
|
70
|
Reasons for withdrawal
| Measure |
Abatacept IV
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
|
Placebo IV
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
|
|---|---|---|
|
Year 1 Period
Lack of Efficacy
|
11
|
9
|
|
Year 1 Period
Adverse Event
|
20
|
17
|
|
Year 1 Period
Withdrawal by Subject
|
6
|
7
|
|
Year 1 Period
Death
|
1
|
1
|
|
Year 1 Period
Lost to Follow-up
|
0
|
2
|
|
Year 1 Period
Poor / non-compliance
|
0
|
1
|
|
Year 1 Period
Pregnancy
|
2
|
0
|
|
Year 1 Period
Participant no longer meets criteria
|
6
|
2
|
|
Year 1 Period
Not treated- received ACE inhibition
|
1
|
0
|
|
Year 1 Period
Change in Concomitant Medication
|
0
|
1
|
|
Year 1 Period
Need of use of Prohibited Medications
|
1
|
0
|
|
Year 1 Period
Antiproteinuric changed/dose increased
|
0
|
1
|
|
Year 1 Period
Hypersensitivity to the medication
|
0
|
1
|
|
Year 2 Period
Lack of Efficacy
|
4
|
12
|
|
Year 2 Period
Adverse Event
|
7
|
6
|
|
Year 2 Period
Participant request to stop treatment
|
4
|
4
|
|
Year 2 Period
Administrative reason by Sponsor
|
4
|
3
|
|
Year 2 Period
Participant withdrew consent
|
1
|
5
|
|
Year 2 Period
Participant no longer meets criteria
|
1
|
4
|
|
Year 2 Period
Lost to Follow-up
|
2
|
0
|
|
Year 2 Period
Participant went to US stopped treatment
|
0
|
1
|
|
Year 2 Period
Pregnancy
|
1
|
1
|
|
Year 2 Period
Completed Year 1, did not enter Year 2
|
2
|
1
|
|
Year 2 Period
Given cyclophosphamide, corticosteroids
|
0
|
1
|
|
Long-Term Extension (LTE) Period
Administrative reason by Sponsor
|
27
|
21
|
|
Long-Term Extension (LTE) Period
Disease progression
|
1
|
4
|
|
Long-Term Extension (LTE) Period
Not effective
|
0
|
1
|
|
Long-Term Extension (LTE) Period
Participant request to stop treatment
|
1
|
1
|
|
Long-Term Extension (LTE) Period
Participant withdrew consent
|
1
|
1
|
|
Long-Term Extension (LTE) Period
Adverse Event unrelated to study drug
|
1
|
0
|
|
Long-Term Extension (LTE) Period
Lost to Follow-up
|
0
|
1
|
|
Long-Term Extension (LTE) Period
Pregnancy
|
1
|
0
|
|
Long-Term Extension (LTE) Period
Study drug toxicity
|
1
|
0
|
|
Long-Term Extension (LTE) Period
Participant no longer meets criteria
|
1
|
0
|
|
Long-Term Extension (LTE) Period
Completed Year 2, did not enter LTE
|
33
|
38
|
|
Long-Term Extension (LTE) Period
Absence of renal response
|
0
|
1
|
|
Long-Term Extension (LTE) Period
Investigator decision, study termination
|
0
|
1
|
|
Long-Term Extension (LTE) Period
Study was terminated
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Baseline characteristics by cohort
| Measure |
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
|
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
71 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
85 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 365Population: All randomized and treated participants
Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no \<85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR\<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no \>10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with \>10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
|
33.5 Percentage
|
35.1 Percentage
Interval 0.8967 to 1.5726
|
SECONDARY outcome
Timeframe: Day 365Population: All randomized and treated nephrotic participants. Nephrotic is defined as screening UPCR \>= 3.0mg/mg (\>=339mg/mmol)
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no \<85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR\<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no \>10 mg prednisone or equivalent for at least 28 days prior. Subjects with \>10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
Outcome measures
| Measure |
Placebo IV
n=88 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=100 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
|
29.5 Percentage
|
27 Percentage
Interval 0.8967 to 1.5726
|
SECONDARY outcome
Timeframe: Baseline and Day 365Population: All randomized and treated nephrotic participants with both post-baseline and baseline measurements
Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants
Outcome measures
| Measure |
Placebo IV
n=68 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=76 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants
|
-4.84 UPCR (mg/mg)
Standard Error 0.35
|
-5.01 UPCR (mg/mg)
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Day 1 and Day 365Population: All randomized and treated participants with both post-baseline and baseline measurements
Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population
Outcome measures
| Measure |
Placebo IV
n=163 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=157 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population
|
-2.90 UPCR (mg/mg)
Standard Error 0.16
|
-2.99 UPCR (mg/mg)
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: All randomized and treated participants with both post-baseline and baseline measurements
Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG "A" represents the presence of serious features of lupus. BILAG "B" represents more moderate features of the disease. BILAG "C" includes only mild symptomatic features. BILAG "D" represents prior activity with no current symptoms due to active lupus. BILAG "E" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.
Outcome measures
| Measure |
Placebo IV
n=161 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=157 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period
|
-7.60 Scores on a Scale
Interval -8.66 to -6.54
|
-8.22 Scores on a Scale
Interval -9.29 to -7.16
|
SECONDARY outcome
Timeframe: From Day 1 up to 56 days post last dose in Year 1 of the double-blind periodPopulation: All treated participants
All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Participants with Serious Adverse Events
|
39 Participants
|
49 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Participants with Adverse Events
|
194 Participants
|
188 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Participants with infection Adverse Events
|
147 Participants
|
150 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Participants with malignancies
|
1 Participants
|
2 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Participants with autoimmune events
|
9 Participants
|
10 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Participants with peri-infusional Adverse Events
|
9 Participants
|
7 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Participants with acute infusional Adverse Events
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants. Year 1 data based on all elements of clinical response definition: UPCR, eGFR and cellular casts. Study terminated and Year 2 data based on only two clinical response definition elements: UPCR and eGFR. Data presented for the "as observed" population (those that completed Day 729).
Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR \< 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR \< 0.5 OR 50% reduced from baseline and \< 1 if baseline value was \< 3, OR 50% reduced from baseline and \< 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
CR - Day 365
|
33.5 Percentage
|
35.1 Percentage
|
|
Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
PR - Day 365
|
21.7 Percentage
|
20.8 Percentage
|
|
Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
NR - Day 365
|
44.8 Percentage
|
44.1 Percentage
|
|
Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
CR - Day 729
|
53.6 Percentage
|
60.7 Percentage
|
|
Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
PR - Day 729
|
22.7 Percentage
|
25.9 Percentage
|
|
Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
NR - Day 729
|
23.6 Percentage
|
13.4 Percentage
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)
The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) \< 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Median Time to Complete Renal Response During the Double-blind Period in All Participants
Day 365
|
309.0 Days
Interval 280.0 to 365.0
|
280.0 Days
Interval 198.0 to 365.0
|
|
Median Time to Complete Renal Response During the Double-blind Period in All Participants
Day 729
|
282.0 Days
Interval 225.0 to 357.0
|
170.0 Days
Interval 141.0 to 225.0
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only); Nephrotic is defined as screening UPCR \>= 3.0 mg/mg (\>=339mg/mmol)
The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) \< 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.
Outcome measures
| Measure |
Placebo IV
n=88 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=100 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants
Day 365
|
368.0 Days
Interval 311.0 to 368.0
|
366.0 Days
Interval 337.0 to
Study terminated, upper limit not met
|
|
Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants
Day 729
|
368.0 Days
Interval 308.0 to 505.0
|
365.0 Days
Interval 197.0 to 644.0
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)
The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR \< 0.5 OR 50% reduced from baseline and \< 1 if baseline value was \< 3, OR 50% reduced from baseline and \< 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Median Time to Partial Renal Response During the Double-blind Period in All Participants
Day 365
|
253.0 Days
Interval 198.0 to 358.0
|
226.0 Days
Interval 198.0 to 313.0
|
|
Median Time to Partial Renal Response During the Double-blind Period in All Participants
Day 729
|
58.0 Days
Interval 57.0 to 85.0
|
59.0 Days
Interval 56.0 to 85.0
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only); Nephrotic is defined as screening UPCR \>= 3.0 mg/mg (\>=339mg/mmol)
The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR \< 0.5 OR 50% reduced from baseline and \< 1 if baseline value was \< 3, OR 50% reduced from baseline and \< 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment
Outcome measures
| Measure |
Placebo IV
n=88 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=100 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants
Day 365
|
196.0 Days
Interval 170.0 to 225.0
|
225.0 Days
Interval 196.0 to 311.0
|
|
Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants
Day 729
|
56.0 Days
Interval 29.0 to 58.0
|
58.5 Days
Interval 29.0 to 86.0
|
SECONDARY outcome
Timeframe: Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy endedPopulation: All randomized and treated participants with both post-baseline and baseline measurements
A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.
Outcome measures
| Measure |
Placebo IV
n=163 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=157 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in UPCR Over Time
Day 365
|
-2.68 UPCR (mg/mg)
Standard Error 0.17
|
-2.95 UPCR (mg/mg)
Standard Error 0.17
|
|
Adjusted Mean Change From Baseline in UPCR Over Time
Day 729
|
-2.72 UPCR (mg/mg)
Standard Error 0.18
|
-3.13 UPCR (mg/mg)
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants with both post-baseline and baseline measurements
A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used. % Change from Baseline = (post baseline - baseline value) / baseline value x 100
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Median Percent Change From Baseline in UPCR Over Time
Day 365
|
-84.12 Percent
Interval -94.03 to -59.98
|
-83.77 Percent
Interval -92.42 to -64.18
|
|
Median Percent Change From Baseline in UPCR Over Time
Day 729
|
-87.28 Percent
Interval -93.78 to -66.43
|
-89.83 Percent
Interval -95.41 to -77.95
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants with both post-baseline and baseline measurements
Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 \[if female\]) X (1.159 \[if black\]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in eGFR Over Time
Day 365
|
5.85 mL/min per 1.73m2
Interval 2.51 to 9.2
|
6.85 mL/min per 1.73m2
Interval 3.47 to 10.23
|
|
Adjusted Mean Change From Baseline in eGFR Over Time
Day 729
|
7.91 mL/min per 1.73m2
Interval 4.14 to 11.68
|
7.20 mL/min per 1.73m2
Interval 3.4 to 11.0
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants
Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn The estimate of median time is based on Kaplan-Meier analysis
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Median Time to First Sustained Change to No Response During the Double-blind Period
Day 365
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
NA Days
Interval 392.0 to
Due to \< 50% event occurrence, the median is not evaluable
|
|
Median Time to First Sustained Change to No Response During the Double-blind Period
Day 729
|
NA Days
Interval 672.0 to
Due to \< 50% event occurrence, the median is not evaluable
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)
Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period
Day 365
|
3 Participants
|
5 Participants
|
|
Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period
Day 729
|
56 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 729; Day 365 to Day 729Population: All randomized and treated participants with both post-baseline and baseline measurements
BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG "A" represents the presence of one or more serious features of lupus. A BILAG "B" represents more moderate features of the disease. A BILAG "C" includes only mild symptomatic features. A BILAG "D" represents only prior activity with no current symptoms due to active lupus. A BILAG "E" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period
Day 1 to Day 729
|
-8.53 Scores on a Scale
Standard Error 0.56
|
-9.31 Scores on a Scale
Standard Error 0.56
|
|
Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period
Day 365 to Day 729
|
-0.40 Scores on a Scale
Standard Error 0.530
|
-0.95 Scores on a Scale
Standard Error 0.538
|
SECONDARY outcome
Timeframe: Days 1 to 365Population: All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period.
Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365
Outcome measures
| Measure |
Placebo IV
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=189 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 15
|
—
|
69.97 ug/mL
Geometric Coefficient of Variation 91.4
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 29
|
—
|
90.46 ug/mL
Geometric Coefficient of Variation 56.8
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 57
|
—
|
36.43 ug/mL
Geometric Coefficient of Variation 84.4
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 85
|
—
|
34.46 ug/mL
Geometric Coefficient of Variation 55.4
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 113
|
—
|
16.42 ug/mL
Geometric Coefficient of Variation 69.2
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 169
|
—
|
13.98 ug/mL
Geometric Coefficient of Variation 64.5
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 281
|
—
|
14.44 ug/mL
Geometric Coefficient of Variation 54.7
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 337
|
—
|
14.99 ug/mL
Geometric Coefficient of Variation 73.6
|
|
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Day 365
|
—
|
13.62 ug/mL
Geometric Coefficient of Variation 51.7
|
SECONDARY outcome
Timeframe: at 1 hour post Day 1 dose and 30 minutes post Day 337 dosePopulation: All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period
Cmax: Maximum observed serum concentration following participants receiving active abatacept IV
Outcome measures
| Measure |
Placebo IV
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=185 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV
Day 1
|
—
|
527.43 ug/mL
Geometric Coefficient of Variation 59.6
|
|
Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV
Day 337
|
—
|
203.51 ug/mL
Geometric Coefficient of Variation 30.6
|
SECONDARY outcome
Timeframe: Days 337 to 365Population: All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period
AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.
Outcome measures
| Measure |
Placebo IV
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=106 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval
|
—
|
36480.24 ug*h/mL
Geometric Coefficient of Variation 29.2
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants
Summary statistics for systolic blood pressure
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Summary Statistics for Systolic Blood Pressure
Day 365, end of observation
|
115.0 mmHg
Standard Deviation 7.07
|
112.3 mmHg
Standard Deviation 18.45
|
|
Summary Statistics for Systolic Blood Pressure
Day 1, end of observation
|
122.6 mmHg
Standard Deviation 15.31
|
122.0 mmHg
Standard Deviation 15.48
|
|
Summary Statistics for Systolic Blood Pressure
Day 729, end of observation
|
114.2 mmHg
Standard Deviation 14.51
|
108.6 mmHg
Standard Deviation 13.29
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants
Summary statistics for diastolic blood pressure
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Summary Statistics for Diastolic Blood Pressure
Day 1, end of observation
|
77.0 mmHg
Standard Deviation 11.19
|
76.5 mmHg
Standard Deviation 11.49
|
|
Summary Statistics for Diastolic Blood Pressure
Day 365, end of observation
|
77.5 mmHg
Standard Deviation 10.61
|
73.5 mmHg
Standard Deviation 10.75
|
|
Summary Statistics for Diastolic Blood Pressure
Day 729, end of observation
|
72.7 mmHg
Standard Deviation 9.45
|
67.5 mmHg
Standard Deviation 9.60
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants
Summary statistics for Heart Rate
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Summary Statistics for Heart Rate
Day 1, end of observation
|
81.4 beats per minute
Standard Deviation 10.64
|
80.6 beats per minute
Standard Deviation 10.91
|
|
Summary Statistics for Heart Rate
Day 365, end of observation
|
70.0 beats per minute
Standard Deviation 14.14
|
78.5 beats per minute
Standard Deviation 9.57
|
|
Summary Statistics for Heart Rate
Day 729, end of observation
|
76.7 beats per minute
Standard Deviation 10.36
|
76.2 beats per minute
Standard Deviation 11.69
|
SECONDARY outcome
Timeframe: Day 729Population: All treated participants with both post-baseline and baseline measurements
Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol. Change from Baseline = Post-baseline - Baseline value.
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
ALANINE AMINOTRANSFERASE (ALT) (U/L)
|
-3.4 U/L
Interval -6.462 to -0.435
|
-2.2 U/L
Interval -4.834 to 0.382
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
ALKALINE PHOSPHATASE (ALP) (U/L)
|
11.7 U/L
Interval 7.125 to 16.202
|
8.2 U/L
Interval 4.514 to 11.967
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
ASPARTATE AMINOTRANSFERASE (AST) (U/L)
|
0.3 U/L
Interval -1.326 to 1.947
|
0.3 U/L
Interval -1.747 to 2.288
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
G-GLUTAMYL TRANSFERASE (GGT) (U/L)
|
-4.1 U/L
Interval -11.419 to 3.143
|
-5.3 U/L
Interval -11.02 to 0.509
|
SECONDARY outcome
Timeframe: Day 729Population: All treated participants with both post-baseline and baseline measurements
Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol. Change from Baseline = Post-baseline - Baseline value.
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
ALBUMIN (g/L)
|
8.1 g/L
Interval 6.917 to 9.308
|
9.2 g/L
Interval 8.04 to 10.336
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
HEMOGLOBIN (g/L)
|
9.0 g/L
Interval 5.48 to 12.449
|
8.8 g/L
Interval 5.977 to 11.574
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
PROTEIN, TOTAL (g/L)
|
10.1 g/L
Interval 8.438 to 11.786
|
9.9 g/L
Interval 8.135 to 11.579
|
SECONDARY outcome
Timeframe: Day 729Population: All treated participants with both post-baseline and baseline measurements
Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol. Change from Baseline = Post-baseline - Baseline value.
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)
|
0.0325 Percentage
Interval 0.021813 to 0.04316
|
0.0328 Percentage
Interval 0.023873 to 0.041658
|
SECONDARY outcome
Timeframe: Day 729Population: All treated participants with both post-baseline and baseline measurements
Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol. Change from Baseline = Post-baseline - Baseline value.
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)
BILIRUBIN, TOTAL (umol/L)
|
1.00 umol/L
Interval 0.5112 to 1.4922
|
1.77 umol/L
Interval 1.0751 to 2.4633
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)
CREATININE (umol/L)
|
-6.2 umol/L
Interval -10.764 to -1.598
|
-5.6 umol/L
Interval -9.306 to -1.912
|
SECONDARY outcome
Timeframe: Day 729Population: All treated participants with both post-baseline and baseline measurements
Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol. Change from Baseline = Post-baseline - Baseline value.
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
BLOOD UREA NITROGEN (mmol/L)
|
-2.25 mmol/L
Interval -2.837 to -1.6682
|
-2.31 mmol/L
Interval -2.9879 to -1.6241
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
CALCIUM, TOTAL (mmol/L)
|
0.108 mmol/L
Interval 0.07754 to 0.1385
|
0.097 mmol/L
Interval 0.06893 to 0.12566
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
CHLORIDE, SERUM (mmol/L)
|
-0.5 mmol/L
Interval -1.244 to 0.192
|
-1.1 mmol/L
Interval -1.675 to -0.461
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
GLUCOSE, SERUM (mmol/L)
|
-0.58 mmol/L
Interval -0.9623 to -0.1902
|
-0.23 mmol/L
Interval -0.4924 to 0.0424
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
PHOSPHORUS, INORGANIC (mmol/L)
|
-0.037 mmol/L
Interval -0.08152 to 0.00807
|
-0.077 mmol/L
Interval -0.12699 to -0.02654
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
POTASSIUM, SERUM (mmol/L)
|
-0.10 mmol/L
Interval -0.2115 to 0.0029
|
-0.02 mmol/L
Interval -0.0947 to 0.0646
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
SODIUM, SERUM (mmol/L)
|
-0.5 mmol/L
Interval -1.06 to 0.078
|
-0.2 mmol/L
Interval -0.762 to 0.28
|
SECONDARY outcome
Timeframe: Day 729Population: All treated participants with both post-baseline and baseline measurements
Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol. Change from Baseline = Post-baseline - Baseline value.
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
NEUTROPHILS (ABSOLUTE) (x10^9 cells/L)
|
-2.289 x10^9 cells/L
Interval -2.95652 to -1.62118
|
-2.259 x10^9 cells/L
Interval -2.78568 to -1.7321
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
EOSINOPHILS (ABSOLUTE) (x10^9 cells/L)
|
0.010 x10^9 cells/L
Interval -0.01781 to 0.03781
|
0.034 x10^9 cells/L
Interval 0.01182 to 0.05611
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
LYMPHOCYTES (ABSOLUTE) (x10^9 cells/L)
|
-0.149 x10^9 cells/L
Interval -0.29961 to 0.00138
|
0.141 x10^9 cells/L
Interval -0.01315 to 0.29584
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
MONOCYTES (ABSOLUTE) (x10^9 cells/L)
|
-0.050 x10^9 cells/L
Interval -0.09264 to -0.00772
|
-0.018 x10^9 cells/L
Interval -0.0522 to 0.01649
|
|
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
PLATELET COUNT (x10^9 cells/L)
|
-9.1 x10^9 cells/L
Interval -24.094 to 5.951
|
-4.9 x10^9 cells/L
Interval -16.962 to 7.148
|
SECONDARY outcome
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlierPopulation: All treated participants NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB \>3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT \<0.75X PRE RX ERYTHROCYTES x10\*12 c/L 5.2 RBC \<0.75X PRE RX PLATELET COUNT x10\*9 c/L 5.0 PLAT \<0.67X LLN OR \>1.5X ULN, OR IF PRE RX\<LLN THEN USE 0.5X PRE RX AND \<100,000/MM3 LEUKOCYTES x10\*9 c/L 6.2 WBC \<0.75X LLN OR \>1.25X ULN, OR IF PRE RX\<LLN THEN USE \<0.8X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.2X PRE RX OR \<LLN EOSINOPHILS (ABSOLUTE) x10\*9 c/L 8.3 EOSA IF VALUE \> .750 X10\*3 c/uL BASOPHILS (ABSOLUTE) x10\*9 c/L 8.3 BASOA IF VALUE \> 400/MM3 MONOCYTES (ABSOLUTE) x10\*9 c/L 8.3 MONOA IF VALUE \> 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10\*9 c/L 8.3 LYMPA IF VALUE \< .750 X10\*3 c/uL OR IF VALUE \> 7.50 X10\*3 c/uL N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
BASOPHILS (ABSOLUTE), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
BASOPHILS (ABSOLUTE), high
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
MONOCYTES (ABSOLUTE), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
MONOCYTES (ABSOLUTE), high
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
LYMPHOCYTES (ABSOLUTE), low
|
104 participants
|
81 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
LYMPHOCYTES (ABSOLUTE), high
|
2 participants
|
1 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
HEMOGLOBIN, low
|
10 participants
|
6 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
HEMOGLOBIN, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
HEMATOCRIT, low
|
12 participants
|
12 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
HEMATOCRIT, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
ERYTHROCYTES, low
|
10 participants
|
7 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
ERYTHROCYTES, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
PLATELET COUNT, low
|
3 participants
|
4 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
PLATELET COUNT, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
LEUKOCYTES, low
|
21 participants
|
35 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
LEUKOCYTES, high
|
25 participants
|
29 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
EOSINOPHILS (ABSOLUTE), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
EOSINOPHILS (ABSOLUTE), high
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlierPopulation: All treated participants NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP \>2X ULN, OR IF PRE RX\>ULN THEN USE \>3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST \>3X ULN, OR IF PRE RX\>ULN THEN USE \>4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT \>3X ULN, OR IF PRE RX\>ULN THEN USE \>4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT \>2X ULN, OR IF PRE RX\>ULN THEN USE \>3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI \>2X ULN, OR IF PRE RX\>ULN THEN USE \>4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI \>1.5X ULN, OR IF PRE RX\>ULN THEN USE \>2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN \>2X PRE RX CREATININE umol/L 5.0 CREAT \>1.5X PRE RX N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
ALKALINE PHOSPHATASE (ALP), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
ALKALINE PHOSPHATASE (ALP), high
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
ASPARTATE AMINOTRANSFERASE (AST), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
ASPARTATE AMINOTRANSFERASE (AST), high
|
0 participants
|
5 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
ALANINE AMINOTRANSFERASE (ALT), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
ALANINE AMINOTRANSFERASE (ALT), high
|
2 participants
|
8 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
G-GLUTAMYL TRANSFERASE (GGT), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
G-GLUTAMYL TRANSFERASE (GGT), high
|
15 participants
|
17 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
BILIRUBIN, TOTAL, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
BILIRUBIN, TOTAL, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
BILIRUBIN, DIRECT, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
BILIRUBIN, DIRECT, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
BLOOD UREA NITROGEN, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
BLOOD UREA NITROGEN, high
|
12 participants
|
20 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
CREATININE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
CREATININE, high
|
20 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlierPopulation: All treated participants
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA \<0.95X LLN OR \>1.05X ULN, OR IF PRE RX\<LLN THEN USE \<0.95X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.05X PRE RX OR \<LLN POTASSIUM, SERUM mmol/L 4.1 K \<0.9X LLN OR \>1.1X ULN, OR IF PRE RX\<LLN THEN USE \<0.9X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.1X PRE RX OR \<LLN CHLORIDE, SERUM mmol/L 5.0 CL \<0.9X LLN OR \>1.1X ULN, OR IF PRE RX\<LLN THEN USE \<0.9X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.1X PRE RX OR \<LLN N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
SODIUM, SERUM, low
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
SODIUM, SERUM, high
|
2 participants
|
2 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
POTASSIUM, SERUM, low
|
5 participants
|
3 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
POTASSIUM, SERUM, high
|
7 participants
|
7 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
CHLORIDE, SERUM, low
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
CHLORIDE, SERUM, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
CALCIUM, TOTAL, low
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
CALCIUM, TOTAL, high
|
0 participants
|
2 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
PHOSPHORUS, INORGANIC, low
|
7 participants
|
9 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
PHOSPHORUS, INORGANIC, high
|
13 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlierPopulation: All treated participants N = the number of participants with at least 1 on treatment lab result for each analyte NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
PROTEIN, URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
PROTEIN, URINE, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
GLUCOSE, URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
GLUCOSE, URINE, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
BLOOD, URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
BLOOD, URINE, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
Red blood cells (RBC), URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
Red blood cells (RBC), URINE, high
|
103 participants
|
93 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
White blood cells (WBC), URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
White blood cells (WBC), URINE, high
|
98 participants
|
91 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlierPopulation: All treated participants NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA \<0.8X LLN OR \>1.2X ULN, OR IF PRE RX\<LLN THEN USE \<0.75X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.25X PRE RX OR \<LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS \<0.75X LLN OR \>1.25X ULN, OR IF PRE RX\<LLN THEN USE \<0.67X PRE RX OR \>ULN GLUCOSE, SERUM mmol/L 4.1 GLUC \<65 mg/dL, OR \>220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO \<0.9X LLN OR \>1.1X ULN, OR IF PRE RX\<LLN THEN USE 0.9X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE 1.1X PRE RX OR \<LLN ALBUMIN g/L 3.0 ALB \<0.9X LLN, OR IF PRE RX\<LLN THEN USE \<0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL \>2X PRE R N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
GLUCOSE, SERUM, low
|
29 participants
|
33 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
GLUCOSE, SERUM, high
|
5 participants
|
10 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
PROTEIN, TOTAL, low
|
26 participants
|
44 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
PROTEIN, TOTAL, high
|
1 participants
|
0 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
ALBUMIN, low
|
11 participants
|
10 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
ALBUMIN, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
SECONDARY outcome
Timeframe: From the first dose in Year 2 of the double-blind period up to 56 days post last dosePopulation: All treated participants in Year 2
All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
Participants with Adverse Events
|
137 Participants
|
127 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
Participants with Serious Adverse Events
|
25 Participants
|
15 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
Participants with infection Adverse Events
|
107 Participants
|
100 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
Participants with malignancies
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
Participants with autoimmune events
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants
Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20. Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
OTF - Day 729
|
8.4 Percentage
Interval 3.6 to 13.1
|
5.2 Percentage
Interval 1.5 to 9.0
|
|
Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
Lupus treatment failure (LTF) - Day 365
|
4.4 Percentage
Interval 1.602 to 7.265
|
3.5 Percentage
Interval 0.943 to 5.988
|
|
Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
Overall treatment failure (OTF) - Day 365
|
4.9 Percentage
Interval 1.949 to 7.903
|
4.5 Percentage
Interval 1.61 to 7.301
|
|
Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
LTF - Day 729
|
5.3 Percentage
Interval 1.5 to 9.2
|
4.5 Percentage
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All randomized and treated participants
First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20. Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor. The hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR. The estimate of median time is based on Kaplan-Meier analysis
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
First treatment failure (FTF) - Day 365
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
|
Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
Overall treatment failure (OTF) - Day 365
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
|
Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
FTF - Day 729
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
|
Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
OTF - Day 729
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
NA Days
Due to \< 50% event occurrence, the median is not evaluable
|
SECONDARY outcome
Timeframe: Day 729Population: All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only). Nephrotic is defined as screening UPCR \>= 3.0mg/mg (\>=339mg/mmol)
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no \<85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR\<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no \>10 mg prednisone or equivalent for at least 28 days prior. Subjects with \>10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=62 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
|
49.0 Percentage
|
50.0 Percentage
|
SECONDARY outcome
Timeframe: Day 729Population: All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no \<85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR\<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no \>10 mg prednisone or equivalent for at least 28 days prior. Subjects with \>10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
Outcome measures
| Measure |
Placebo IV
n=131 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=134 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
|
52.7 Percentage
|
61.9 Percentage
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB \>3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT \<0.75X PRE RX ERYTHROCYTES x10\*12 c/L 5.2 RBC \<0.75X PRE RX PLATELET COUNT x10\*9 c/L 5.0 PLAT \<0.67X LLN OR \>1.5X ULN, OR IF PRE RX\<LLN THEN USE 0.5X PRE RX AND \<100,000/MM3 LEUKOCYTES x10\*9 c/L 6.2 WBC \<0.75X LLN OR \>1.25X ULN, OR IF PRE RX\<LLN THEN USE \<0.8X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.2X PRE RX OR \<LLN EOSINOPHILS (ABSOLUTE) x10\*9 c/L 8.3 EOSA IF VALUE \> .750 X10\*3 c/uL BASOPHILS (ABSOLUTE) x10\*9 c/L 8.3 BASOA IF VALUE \> 400/MM3 MONOCYTES (ABSOLUTE) x10\*9 c/L 8.3 MONOA IF VALUE \> 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10\*9 c/L 8.3 LYMPA IF VALUE \< .750 X10\*3 c/uL OR IF VALUE \> 7.50 X10\*3 c/uL N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
HEMOGLOBIN, low
|
9 participants
|
8 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
HEMOGLOBIN, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
HEMATOCRIT, low
|
2 participants
|
6 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
HEMATOCRIT, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
ERYTHROCYTES, low
|
2 participants
|
4 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
ERYTHROCYTES, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
PLATELET COUNT, low
|
4 participants
|
2 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
PLATELET COUNT, high
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
LEUKOCYTES, low
|
24 participants
|
19 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
LEUKOCYTES, high
|
5 participants
|
3 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
EOSINOPHILS (ABSOLUTE), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
EOSINOPHILS (ABSOLUTE), high
|
6 participants
|
11 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
BASOPHILS (ABSOLUTE), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
BASOPHILS (ABSOLUTE), high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
MONOCYTES (ABSOLUTE), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
MONOCYTES (ABSOLUTE), high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
LYMPHOCYTES (ABSOLUTE), low
|
62 participants
|
43 participants
|
|
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
LYMPHOCYTES (ABSOLUTE), high
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP \>2X ULN, OR IF PRE RX\>ULN THEN USE \>3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST \>3X ULN, OR IF PRE RX\>ULN THEN USE \>4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT \>3X ULN, OR IF PRE RX\>ULN THEN USE \>4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT \>2X ULN, OR IF PRE RX\>ULN THEN USE \>3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI \>2X ULN, OR IF PRE RX\>ULN THEN USE \>4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI \>1.5X ULN, OR IF PRE RX\>ULN THEN USE \>2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN \>2X PRE RX CREATININE umol/L 5.0 CREAT \>1.5X PRE RX N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
ALKALINE PHOSPHATASE (ALP), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
ALKALINE PHOSPHATASE (ALP), high
|
0 participants
|
4 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
ASPARTATE AMINOTRANSFERASE (AST), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
ASPARTATE AMINOTRANSFERASE (AST), high
|
3 participants
|
2 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
ALANINE AMINOTRANSFERASE (ALT), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
ALANINE AMINOTRANSFERASE (ALT), high
|
3 participants
|
4 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
G-GLUTAMYL TRANSFERASE (GGT), low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
G-GLUTAMYL TRANSFERASE (GGT), high
|
11 participants
|
17 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
BILIRUBIN, TOTAL, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
BILIRUBIN, TOTAL, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
BILIRUBIN, DIRECT, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
BILIRUBIN, DIRECT, high
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
BLOOD UREA NITROGEN, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
BLOOD UREA NITROGEN, high
|
9 participants
|
10 participants
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
CREATININE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
CREATININE, high
|
16 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA \<0.95X LLN OR \>1.05X ULN, OR IF PRE RX\<LLN THEN USE \<0.95X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.05X PRE RX OR \<LLN POTASSIUM, SERUM mmol/L 4.1 K \<0.9X LLN OR \>1.1X ULN, OR IF PRE RX\<LLN THEN USE \<0.9X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.1X PRE RX OR \<LLN CHLORIDE, SERUM mmol/L 5.0 CL \<0.9X LLN OR \>1.1X ULN, OR IF PRE RX\<LLN THEN USE \<0.9X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.1X PRE RX OR \<LLN N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
SODIUM, SERUM, low
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
SODIUM, SERUM, high
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
POTASSIUM, SERUM, low
|
2 participants
|
2 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
POTASSIUM, SERUM, high
|
2 participants
|
3 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
CHLORIDE, SERUM, low
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
CHLORIDE, SERUM, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
CALCIUM, TOTAL, low
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
CALCIUM, TOTAL, high
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
PHOSPHORUS, INORGANIC, low
|
4 participants
|
3 participants
|
|
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
PHOSPHORUS, INORGANIC, high
|
3 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants N = the number of participants with at least 1 on treatment lab result for each analyte NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE \>=2, OR IF VALUE \>=4, OR IF PRE RX =0 OR 0.5 THEN USE \>=2, OR IF PRE RX =1 THEN USE \>=3, OR IF PRE RX =2 OR 3 THEN USE \>=4
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
PROTEIN, URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
PROTEIN, URINE, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
GLUCOSE, URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
GLUCOSE, URINE, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
BLOOD, URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
BLOOD, URINE, high
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
Red blood cells (RBC), URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
Red blood cells (RBC), URINE, high
|
55 participants
|
58 participants
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
White blood cells (WBC), URINE, low
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
|
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
White blood cells (WBC), URINE, high
|
59 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 729Population: All treated participants NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA \<0.8X LLN OR \>1.2X ULN, OR IF PRE RX\<LLN THEN USE \<0.75X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE \>1.25X PRE RX OR \<LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS \<0.75X LLN OR \>1.25X ULN, OR IF PRE RX\<LLN THEN USE \<0.67X PRE RX OR \>ULN GLUCOSE, SERUM mmol/L 4.1 GLUC \<65 mg/dL, OR \>220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO \<0.9X LLN OR \>1.1X ULN, OR IF PRE RX\<LLN THEN USE 0.9X PRE RX OR \>ULN, OR IF PRE RX\>ULN THEN USE 1.1X PRE RX OR \<LLN ALBUMIN g/L 3.0 ALB \<0.9X LLN, OR IF PRE RX\<LLN THEN USE \<0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL \>2X PRE R N = the number of participants with at least 1 on treatment lab result for each analyte
Outcome measures
| Measure |
Placebo IV
n=160 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=153 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
GLUCOSE, SERUM, low
|
24 participants
|
15 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
GLUCOSE, SERUM, high
|
2 participants
|
3 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
GLUCOSE, FASTING SERUM, low
|
1 participants
|
3 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
GLUCOSE, FASTING SERUM, high
|
1 participants
|
3 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
PROTEIN, TOTAL, low
|
7 participants
|
10 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
PROTEIN, TOTAL, high
|
3 participants
|
2 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
ALBUMIN, low
|
5 participants
|
4 participants
|
|
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
ALBUMIN, high
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
NA participants
Pre-specified marked lab abnormalities criteria do not include this low/high end value
|
SECONDARY outcome
Timeframe: Day 365, Day 729Population: All treated participants in the immunogenicity analysis population for Year 1. Note: Study terminated, Year 2 data not collected
Participants who experienced a positive antibody response relative to baseline (ECL Assay)
Outcome measures
| Measure |
Placebo IV
n=203 Participants
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
|
Abatacept IV
n=202 Participants
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
|
|---|---|---|
|
Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period
Day 365, overall
|
9 Participants
|
7 Participants
|
Adverse Events
Abatacept IV
Serious events: 62 serious events
Other events: 164 other events
Deaths: 7 deaths
Placebo IV
Serious events: 58 serious events
Other events: 179 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Abatacept IV
n=202 participants at risk
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
|
Placebo IV
n=203 participants at risk
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
3/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Cardiac disorders
Lupus myocarditis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Eye disorders
Cataract
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Food poisoning
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Chest pain
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Generalised oedema
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Oedema peripheral
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Pyrexia
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Serositis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Anal abscess
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Candida infection
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Cellulitis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Encephalitis
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Gastroenteritis
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Genital herpes
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Herpes zoster
|
2.5%
5/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
2.0%
4/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Lung infection
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Peritonitis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Pneumonia
|
7.4%
15/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
3.0%
6/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Salmonella bacteraemia
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Sepsis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Septic shock
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Sinusitis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Subcutaneous abscess
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Toxoplasmosis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Tuberculosis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
2.0%
4/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Viral infection
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
2.5%
5/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of conjunctiva
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Headache
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Lupus encephalitis
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Seizure
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.5%
3/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Psychiatric disorders
Depression
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Psychiatric disorders
Psychogenic seizure
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Renal and urinary disorders
Lupus nephritis
|
2.0%
4/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Renal and urinary disorders
Renal failure
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.99%
2/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.50%
1/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.99%
2/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.00%
0/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Vascular disorders
Vasculitis
|
0.00%
0/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
0.49%
1/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
Other adverse events
| Measure |
Abatacept IV
n=202 participants at risk
Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
|
Placebo IV
n=203 participants at risk
Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.9%
20/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
11.3%
23/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
9/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
6.9%
14/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
23.3%
47/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
22.7%
46/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Nausea
|
6.4%
13/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
8.4%
17/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
12/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
3.4%
7/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Oedema peripheral
|
7.4%
15/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
6.4%
13/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
General disorders
Pyrexia
|
4.5%
9/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
6.4%
13/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Bronchitis
|
8.9%
18/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
12.8%
26/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Conjunctivitis
|
6.9%
14/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
7.4%
15/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Gastroenteritis
|
5.9%
12/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
8.4%
17/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Herpes zoster
|
9.9%
20/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
8.9%
18/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Influenza
|
5.4%
11/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
4.4%
9/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Nasopharyngitis
|
19.8%
40/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
21.7%
44/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Pharyngitis
|
9.9%
20/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
11.8%
24/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
21.3%
43/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
20.7%
42/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Infections and infestations
Urinary tract infection
|
22.3%
45/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
18.7%
38/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.4%
21/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
9.4%
19/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
9/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
7.9%
16/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Dizziness
|
5.9%
12/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
2.5%
5/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Nervous system disorders
Headache
|
11.9%
24/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
11.3%
23/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Psychiatric disorders
Insomnia
|
6.4%
13/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
9.9%
20/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.4%
25/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
11.8%
24/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.4%
13/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
4.9%
10/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
11/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
9.9%
20/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Vascular disorders
Hypertension
|
3.5%
7/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
5.9%
12/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
|
Vascular disorders
Hypotension
|
2.5%
5/202 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
6.4%
13/203 • From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER