Trial Outcomes & Findings for A Study of CC-99677 in Participants With Active Ankylosing Spondylitis (NCT NCT04947579)
NCT ID: NCT04947579
Last Updated: 2024-05-01
Results Overview
Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: * Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]); * Total Back Pain NRS; * Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS); * Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Week 12
Results posted on
2024-05-01
Participant Flow
Participants originally randomized to the CC-99677 60 mg or 150 mg Biologic Naive or Biologic Failure arms in the Placebo-Controlled period continued receiving the same intervention until week 64 in the Long-Term Extension period.
Participant milestones
| Measure |
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Week 0 - Week 12 (Placebo-Controlled)
STARTED
|
49
|
49
|
49
|
5
|
7
|
8
|
|
Week 0 - Week 12 (Placebo-Controlled)
COMPLETED
|
42
|
42
|
39
|
3
|
5
|
7
|
|
Week 0 - Week 12 (Placebo-Controlled)
NOT COMPLETED
|
7
|
7
|
10
|
2
|
2
|
1
|
|
Week 12 - Week 64 (Long-Term Extension)
STARTED
|
0
|
63
|
61
|
0
|
7
|
8
|
|
Week 12 - Week 64 (Long-Term Extension)
Placebo Patients Re-randomized to CC-99677 60 mg
|
0
|
21
|
0
|
0
|
2
|
0
|
|
Week 12 - Week 64 (Long-Term Extension)
Placebo Patients Re-randomized to CC-99677 150 mg
|
0
|
0
|
21
|
0
|
0
|
1
|
|
Week 12 - Week 64 (Long-Term Extension)
COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Week 12 - Week 64 (Long-Term Extension)
NOT COMPLETED
|
0
|
62
|
60
|
0
|
7
|
8
|
Reasons for withdrawal
| Measure |
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Week 0 - Week 12 (Placebo-Controlled)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Week 0 - Week 12 (Placebo-Controlled)
Other reasons
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Week 0 - Week 12 (Placebo-Controlled)
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
2
|
0
|
|
Week 0 - Week 12 (Placebo-Controlled)
Study terminated by sponsor
|
5
|
6
|
7
|
1
|
0
|
1
|
|
Week 0 - Week 12 (Placebo-Controlled)
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Week 12 - Week 64 (Long-Term Extension)
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Week 12 - Week 64 (Long-Term Extension)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Week 12 - Week 64 (Long-Term Extension)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Week 12 - Week 64 (Long-Term Extension)
Study terminated by sponsor
|
0
|
54
|
46
|
0
|
5
|
4
|
|
Week 12 - Week 64 (Long-Term Extension)
Withdrawal by Subject
|
0
|
2
|
4
|
0
|
1
|
3
|
|
Week 12 - Week 64 (Long-Term Extension)
Other reasons
|
0
|
5
|
8
|
0
|
1
|
0
|
Baseline Characteristics
A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Placebo Biologic Naive
n=49 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=49 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=49 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=5 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=7 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=8 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
40.5 Years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
40.4 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
43.8 Years
STANDARD_DEVIATION 7.16 • n=4 Participants
|
44.4 Years
STANDARD_DEVIATION 10.06 • n=21 Participants
|
42.5 Years
STANDARD_DEVIATION 9.46 • n=10 Participants
|
41.9 Years
STANDARD_DEVIATION 10.48 • n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
139 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
163 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
164 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All treated participants who have non-missing response at week 12
Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: * Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]); * Total Back Pain NRS; * Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS); * Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
Outcome measures
| Measure |
Placebo Biologic Naive
n=41 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=41 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=6 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ASAS 20 at Week 12
|
48.8 Percentage of Participants
|
51.2 Percentage of Participants
|
56.1 Percentage of Participants
|
66.7 Percentage of Participants
|
83.3 Percentage of Participants
|
57.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants who have non-missing response at week 12
Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: * Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]); * Total Back Pain NRS; * Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS); * Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
Outcome measures
| Measure |
Placebo Biologic Naive
n=41 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=41 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=6 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ASAS 40 at Week 12
|
22.0 Percentage of Participants
|
25.6 Percentage of Participants
|
34.1 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
28.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All treated participants with baseline and week 12 measurements
ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: \<1.3 inactive disease, ≥1.3 and \<2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)
Outcome measures
| Measure |
Placebo Biologic Naive
n=40 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=41 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=5 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
|
-0.69 Units on a scale
Standard Deviation 0.856
|
-0.87 Units on a scale
Standard Deviation 0.681
|
-0.80 Units on a scale
Standard Deviation 0.869
|
-0.84 Units on a scale
Standard Deviation 0.621
|
-1.02 Units on a scale
Standard Deviation 0.464
|
-0.44 Units on a scale
Standard Deviation 0.323
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All treated participants with baseline and week 12 measurements
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Outcome measures
| Measure |
Placebo Biologic Naive
n=43 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=41 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=6 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Change From Baseline in BASDAI at Week 12
|
-1.88 Units on a scale
Standard Deviation 1.862
|
-1.96 Units on a scale
Standard Deviation 1.494
|
-2.03 Units on a scale
Standard Deviation 2.080
|
-1.63 Units on a scale
Standard Deviation 0.651
|
-2.20 Units on a scale
Standard Deviation 1.394
|
-1.43 Units on a scale
Standard Deviation 1.517
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All treated participants with baseline and week 12 measurements
Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Outcome measures
| Measure |
Placebo Biologic Naive
n=41 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=41 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=6 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Change From Baseline in BASFI at Week 12
|
-1.22 Units on a scale
Standard Deviation 1.727
|
-1.33 Units on a scale
Standard Deviation 1.985
|
-1.28 Units on a scale
Standard Deviation 2.542
|
-1.77 Units on a scale
Standard Deviation 0.850
|
-1.47 Units on a scale
Standard Deviation 1.841
|
-1.29 Units on a scale
Standard Deviation 0.703
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All treated participants with baseline and week 12 measurements
Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Outcome measures
| Measure |
Placebo Biologic Naive
n=38 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=39 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=5 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the SPARCC SI Joint Score at Week 12
|
0.25 Units on a scale
Standard Deviation 3.168
|
-0.81 Units on a scale
Standard Deviation 5.453
|
-1.72 Units on a scale
Standard Deviation 6.084
|
-0.17 Units on a scale
Standard Deviation 1.258
|
-3.00 Units on a scale
Standard Deviation 7.608
|
-3.00 Units on a scale
Standard Deviation 4.093
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All treated participants with baseline and week 12 measurements
Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Outcome measures
| Measure |
Placebo Biologic Naive
n=38 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=39 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=5 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the SPARCC Spine Score at Week 12
|
-0.92 Units on a scale
Standard Deviation 7.557
|
-1.53 Units on a scale
Standard Deviation 8.331
|
-1.86 Units on a scale
Standard Deviation 7.081
|
-8.17 Units on a scale
Standard Deviation 7.371
|
-2.40 Units on a scale
Standard Deviation 5.128
|
-2.71 Units on a scale
Standard Deviation 8.640
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All treated participants with baseline and week 12 measurements
Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Outcome measures
| Measure |
Placebo Biologic Naive
n=42 Participants
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=43 Participants
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Naive
n=41 Participants
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=3 Participants
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=5 Participants
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=7 Participants
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in hsCRP at Week 12
|
72.83 Percent change in hsCRP
Standard Deviation 474.199
|
-1.43 Percent change in hsCRP
Standard Deviation 64.157
|
20.88 Percent change in hsCRP
Standard Deviation 130.181
|
-13.68 Percent change in hsCRP
Standard Deviation 55.618
|
8.52 Percent change in hsCRP
Standard Deviation 66.057
|
452.34 Percent change in hsCRP
Standard Deviation 1226.664
|
Adverse Events
CC-99677 150 mg Biologic Naive
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
CC-99677 60 mg Biologic Naive
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo Biologic Naive
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo to CC-99677 150 mg Biologic Naive
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
Placebo to CC-99677 60 mg Biologic Naive
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CC-99677 150 mg Biologic Failure
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
CC-99677 60 mg Biologic Failure
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Biologic Failure
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo to CC-99677 150 mg Biologic Failure
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo to CC-99677 60 mg Biologic Failure
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CC-99677 150 mg Biologic Naive
n=49 participants at risk
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=49 participants at risk
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Naive
n=7 participants at risk
Placebo Biologic Naive QD PO from week 0 - 12
|
Placebo to CC-99677 150 mg Biologic Naive
n=21 participants at risk
At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
|
Placebo to CC-99677 60 mg Biologic Naive
n=21 participants at risk
At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=8 participants at risk
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=7 participants at risk
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=2 participants at risk
Placebo Biologic Failure QD PO from week 0 - 12
|
Placebo to CC-99677 150 mg Biologic Failure
n=1 participants at risk
At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
|
Placebo to CC-99677 60 mg Biologic Failure
n=2 participants at risk
At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
General disorders
Asthenia
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
Other adverse events
| Measure |
CC-99677 150 mg Biologic Naive
n=49 participants at risk
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Naive
n=49 participants at risk
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Naive
n=7 participants at risk
Placebo Biologic Naive QD PO from week 0 - 12
|
Placebo to CC-99677 150 mg Biologic Naive
n=21 participants at risk
At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
|
Placebo to CC-99677 60 mg Biologic Naive
n=21 participants at risk
At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
|
CC-99677 150 mg Biologic Failure
n=8 participants at risk
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
CC-99677 60 mg Biologic Failure
n=7 participants at risk
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
|
Placebo Biologic Failure
n=2 participants at risk
Placebo Biologic Failure QD PO from week 0 - 12
|
Placebo to CC-99677 150 mg Biologic Failure
n=1 participants at risk
At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
|
Placebo to CC-99677 60 mg Biologic Failure
n=2 participants at risk
At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Otitis media
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Pharyngitis
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
9.5%
2/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
General disorders
Pyrexia
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
COVID-19
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
16.3%
8/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
19.0%
4/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.2%
6/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
9.5%
2/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Viral infection
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Investigations
Transaminases increased
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
9.5%
2/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Rhinitis
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
9.5%
2/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
4.8%
1/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/21 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
|
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