Trial Outcomes & Findings for A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (NCT NCT01483599)
NCT ID: NCT01483599
Last Updated: 2017-08-02
Results Overview
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
293 participants
Primary outcome timeframe
Week 16
Results posted on
2017-08-02
Participant Flow
Participant milestones
| Measure |
Placebo (CP)
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
|
CNTO1959 5 mg (CP)
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 15 mg (CP)
Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 50 mg (CP)
Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 100 mg (CP)
Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 200 mg (CP)
Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
Adalimumab (CP)
Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
|
Placebo -> 100 mg CNTO1959 (After CP)
Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 5 mg (After CP)
Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 15 mg (After CP)
Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 50 mg (After CP)
Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 100 mg (After CP)
Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 200 mg (After CP)
Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
Adalimumab (After CP)
Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Controlled Period (CP) (up to Week 16)
STARTED
|
42
|
41
|
41
|
42
|
42
|
42
|
43
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Controlled Period (CP) (up to Week 16)
Treated
|
42
|
41
|
41
|
42
|
42
|
41
|
43
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Controlled Period (CP) (up to Week 16)
COMPLETED
|
39
|
38
|
41
|
39
|
40
|
38
|
39
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Controlled Period (CP) (up to Week 16)
NOT COMPLETED
|
3
|
3
|
0
|
3
|
2
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
After Controlled Period(Week 16-Week 40)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
39
|
38
|
41
|
39
|
40
|
38
|
39
|
|
After Controlled Period(Week 16-Week 40)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
37
|
29
|
37
|
37
|
39
|
35
|
32
|
|
After Controlled Period(Week 16-Week 40)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
9
|
4
|
2
|
1
|
3
|
7
|
Reasons for withdrawal
| Measure |
Placebo (CP)
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
|
CNTO1959 5 mg (CP)
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 15 mg (CP)
Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 50 mg (CP)
Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 100 mg (CP)
Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 200 mg (CP)
Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
Adalimumab (CP)
Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
|
Placebo -> 100 mg CNTO1959 (After CP)
Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 5 mg (After CP)
Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 15 mg (After CP)
Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 50 mg (After CP)
Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 100 mg (After CP)
Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 200 mg (After CP)
Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
Adalimumab (After CP)
Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Controlled Period (CP) (up to Week 16)
Adverse Event
|
2
|
0
|
0
|
1
|
1
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Controlled Period (CP) (up to Week 16)
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Controlled Period (CP) (up to Week 16)
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Controlled Period (CP) (up to Week 16)
Other
|
0
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
After Controlled Period(Week 16-Week 40)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
After Controlled Period(Week 16-Week 40)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
|
After Controlled Period(Week 16-Week 40)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
|
After Controlled Period(Week 16-Week 40)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
|
After Controlled Period(Week 16-Week 40)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
1
|
4
|
|
After Controlled Period(Week 16-Week 40)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
4
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 5 mg
n=41 Participants
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 15 mg
n=41 Participants
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 50 mg
n=42 Participants
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 100 mg
n=42 Participants
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 200 mg
n=42 Participants
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
Adalimumab
n=43 Participants
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
|
Total
n=293 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
40 Participants
n=30 Participants
|
35 Participants
n=3 Participants
|
271 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 11.97 • n=99 Participants
|
45.2 years
STANDARD_DEVIATION 13.92 • n=107 Participants
|
43.8 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
42.6 years
STANDARD_DEVIATION 12.14 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 13.72 • n=31 Participants
|
45.1 years
STANDARD_DEVIATION 10.96 • n=30 Participants
|
47.5 years
STANDARD_DEVIATION 14.91 • n=3 Participants
|
44.9 years
STANDARD_DEVIATION 13.02 • n=6 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
86 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
31 Participants
n=30 Participants
|
30 Participants
n=3 Participants
|
207 Participants
n=6 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
5 participants
n=7 Participants
|
4 participants
n=31 Participants
|
3 participants
n=30 Participants
|
3 participants
n=3 Participants
|
23 participants
n=6 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
5 participants
n=6 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
7 participants
n=206 Participants
|
10 participants
n=7 Participants
|
7 participants
n=31 Participants
|
8 participants
n=30 Participants
|
8 participants
n=3 Participants
|
55 participants
n=6 Participants
|
|
Region of Enrollment
Canada
|
13 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
11 participants
n=7 Participants
|
12 participants
n=31 Participants
|
14 participants
n=30 Participants
|
11 participants
n=3 Participants
|
83 participants
n=6 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
19 participants
n=107 Participants
|
19 participants
n=206 Participants
|
16 participants
n=7 Participants
|
18 participants
n=31 Participants
|
16 participants
n=30 Participants
|
21 participants
n=3 Participants
|
127 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Population analyzed included all participants who were randomized.
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 5 mg
n=41 Participants
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 15 mg
n=41 Participants
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 50 mg
n=42 Participants
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 100 mg
n=42 Participants
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 200 mg
n=42 Participants
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
Adalimumab
n=43 Participants
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16
|
7.1 percentage of participants
|
34.1 percentage of participants
|
61.0 percentage of participants
|
78.6 percentage of participants
|
85.7 percentage of participants
|
83.3 percentage of participants
|
58.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Population analyzed included all participants who were randomized.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 5 mg
n=41 Participants
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 15 mg
n=41 Participants
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 50 mg
n=42 Participants
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 100 mg
n=42 Participants
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 200 mg
n=42 Participants
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
Adalimumab
n=43 Participants
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
|
4.8 percentage of participants
|
43.9 percentage of participants
|
75.6 percentage of participants
|
81.0 percentage of participants
|
78.6 percentage of participants
|
81.0 percentage of participants
|
69.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Population analyzed included all participants who were randomized.
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 5 mg
n=41 Participants
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 15 mg
n=42 Participants
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 50 mg
n=42 Participants
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 100 mg
n=42 Participants
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 200 mg
n=43 Participants
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
Adalimumab
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|
|
Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16
|
34.1 percentage of participants
|
61.0 percentage of participants
|
78.6 percentage of participants
|
85.7 percentage of participants
|
83.3 percentage of participants
|
58.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 40Population: Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure. The placebo reporting group was not planned to be analyzed in this outcome measure.
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 5 mg
n=37 Participants
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 15 mg
n=38 Participants
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 50 mg
n=39 Participants
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 100 mg
n=37 Participants
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 200 mg
n=37 Participants
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
Adalimumab
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40
|
35.3 percentage of participants
|
59.5 percentage of participants
|
71.1 percentage of participants
|
76.9 percentage of participants
|
81.1 percentage of participants
|
48.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 5 mg
n=39 Participants
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 15 mg
n=41 Participants
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 50 mg
n=40 Participants
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
CNTO1959 100 mg
n=40 Participants
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
|
CNTO1959 200 mg
n=39 Participants
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
|
Adalimumab
n=39 Participants
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
|
-2.3 units on a scale
Standard Deviation 6.80
|
-6.2 units on a scale
Standard Deviation 5.24
|
-10.3 units on a scale
Standard Deviation 5.49
|
-11.1 units on a scale
Standard Deviation 7.38
|
-10.8 units on a scale
Standard Deviation 7.34
|
-11.4 units on a scale
Standard Deviation 6.83
|
-10.1 units on a scale
Standard Deviation 9.00
|
Adverse Events
Placebo (CP)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
CNTO1959 5 mg (CP)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
CNTO1959 15 mg (CP)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
CNTO1959 50 mg (CP)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
CNTO1959 100 mg (CP)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CNTO1959 200 mg (CP)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Adalimumab (CP)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo -> 100 mg CNTO1959 (After CP)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
CNTO1959 5 mg (After CP)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
CNTO1959 15 mg (After CP)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CNTO1959 50 mg (After CP)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
CNTO1959 100 mg (After CP)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
CNTO1959 200 mg (After CP)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Adalimumab (After CP)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (CP)
n=42 participants at risk
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
|
CNTO1959 5 mg (CP)
n=41 participants at risk
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 15 mg (CP)
n=41 participants at risk
Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 50 mg (CP)
n=42 participants at risk
Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 100 mg (CP)
n=42 participants at risk
Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 200 mg (CP)
n=41 participants at risk
Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
Adalimumab (CP)
n=43 participants at risk
Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
|
Placebo -> 100 mg CNTO1959 (After CP)
n=39 participants at risk
Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 5 mg (After CP)
n=38 participants at risk
Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 15 mg (After CP)
n=41 participants at risk
Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 50 mg (After CP)
n=39 participants at risk
Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 100 mg (After CP)
n=40 participants at risk
Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 200 mg (After CP)
n=38 participants at risk
Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
Adalimumab (After CP)
n=38 participants at risk
Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Uterine Prolapse
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Vascular disorders
Haematoma
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.3%
1/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Lung Abscess
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.3%
1/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.5%
1/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Gastrointestinal disorders
Oesophagitis Haemorrhagic
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.5%
1/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
Other adverse events
| Measure |
Placebo (CP)
n=42 participants at risk
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
|
CNTO1959 5 mg (CP)
n=41 participants at risk
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 15 mg (CP)
n=41 participants at risk
Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 50 mg (CP)
n=42 participants at risk
Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
CNTO1959 100 mg (CP)
n=42 participants at risk
Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
|
CNTO1959 200 mg (CP)
n=41 participants at risk
Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
|
Adalimumab (CP)
n=43 participants at risk
Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
|
Placebo -> 100 mg CNTO1959 (After CP)
n=39 participants at risk
Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 5 mg (After CP)
n=38 participants at risk
Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 15 mg (After CP)
n=41 participants at risk
Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 50 mg (After CP)
n=39 participants at risk
Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
CNTO1959 100 mg (After CP)
n=40 participants at risk
Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
|
CNTO1959 200 mg (After CP)
n=38 participants at risk
Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
|
Adalimumab (After CP)
n=38 participants at risk
Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
7.1%
3/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.8%
2/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
General disorders
Influenza Like Illness
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.3%
2/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
General disorders
Injection Site Erythema
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
11.6%
5/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.3%
2/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.1%
2/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.0%
2/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Influenza
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.0%
2/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
14.6%
6/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
9.8%
4/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.9%
2/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.7%
2/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
10.3%
4/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
15.8%
6/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
17.9%
7/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
10.0%
4/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
13.2%
5/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
15.8%
6/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.8%
2/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.1%
2/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.3%
3/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.3%
3/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.7%
2/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
10.3%
4/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
10.5%
4/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.5%
3/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.3%
2/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.9%
3/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.3%
1/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.1%
2/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.5%
1/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.7%
2/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.7%
3/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.3%
2/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.5%
1/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.3%
3/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.8%
2/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.0%
2/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.3%
3/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
9.8%
4/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.8%
2/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.0%
2/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
4.9%
2/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.5%
1/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.3%
2/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.0%
2/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
9.5%
4/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
7.1%
3/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/42 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.4%
1/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/43 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
0.00%
0/41 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/39 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
5.0%
2/40 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
2.6%
1/38 • Baseline (Week 0) up to Week 52
Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER