Trial Outcomes & Findings for A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis (NCT NCT00320216)

NCT ID: NCT00320216

Last Updated: 2015-04-20

Results Overview

Psoriasis Area and Severity Index (PASI)(0 \[ best\] -72 \[worst\]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 320 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2015-04-20

Participant Flow

320 participants from 45 sites in North America were randomized to receive either Ustekinumab or placebo.

Participant milestones

Measure	Placebo (CP) Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.	Ustekinumab 45 mg (CP) Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg (CP) Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Ustekinumab 45 mg Weekly for 4 Weeks (CP) Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg Weekly for 4 Weeks (CP) Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.
Overall Study STARTED	64	64	64	64	64
Overall Study COMPLETED	48	54	58	61	58
Overall Study NOT COMPLETED	16	10	6	3	6

Reasons for withdrawal

Measure	Placebo (CP) Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.	Ustekinumab 45 mg (CP) Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg (CP) Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Ustekinumab 45 mg Weekly for 4 Weeks (CP) Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg Weekly for 4 Weeks (CP) Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.
Overall Study Adverse Event	0	6	0	2	2
Overall Study Lack of Efficacy	6	2	1	0	1
Overall Study Lost to Follow-up	3	0	0	0	0
Overall Study Other	7	2	5	1	3

Baseline Characteristics

A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis

Baseline characteristics by cohort

Measure	Group I: Placebo n=64 Participants Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.	Group II: Ustekinumab 45 mg n=64 Participants Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group III: Ustekinumab 90 mg n=64 Participants Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group IV: Ustekinumab 45 mg Weekly for 4 Weeks n=64 Participants Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group V: Ustekinumab 90 mg Weekly for 4 Weeks n=64 Participants Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Total n=320 Participants Total of all reporting groups
Age, Continuous Years	44.0 Years STANDARD_DEVIATION 13.7 • n=5 Participants	46.4 Years STANDARD_DEVIATION 14.2 • n=7 Participants	45.5 Years STANDARD_DEVIATION 12.7 • n=5 Participants	44.5 Years STANDARD_DEVIATION 12.2 • n=4 Participants	44.3 Years STANDARD_DEVIATION 13.3 • n=21 Participants	44.9 Years STANDARD_DEVIATION 13.2 • n=8 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	26 Participants n=7 Participants	17 Participants n=5 Participants	25 Participants n=4 Participants	52 Participants n=21 Participants	138 Participants n=8 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	38 Participants n=7 Participants	47 Participants n=5 Participants	39 Participants n=4 Participants	12 Participants n=21 Participants	182 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.

Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.

Outcome measures

Measure	Group I: Placebo n=64 Participants Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.	Group II: Ustekinumab 45 mg n=64 Participants Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group III: Ustekinumab 90 mg n=64 Participants Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group IV: Ustekinumab 45 mg Weekly for 4 Weeks n=64 Participants Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group V: Ustekinumab 90 mg Weekly for 4 Weeks n=64 Participants Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.
Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12	1 Participants	33 Participants	38 Participants	43 Participants	52 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.

Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score.

Outcome measures

Measure	Group I: Placebo n=64 Participants Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.	Group II: Ustekinumab 45 mg n=63 Participants Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group III: Ustekinumab 90 mg n=64 Participants Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group IV: Ustekinumab 45 mg Weekly for 4 Weeks n=64 Participants Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group V: Ustekinumab 90 mg Weekly for 4 Weeks n=64 Participants Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.
Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12	0 Participants	32 Participants	34 Participants	46 Participants	53 Participants

SECONDARY outcome

Timeframe: Week 32

Population: Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.

Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.

Outcome measures

Measure	Group I: Placebo n=2 Participants Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.	Group II: Ustekinumab 45 mg n=24 Participants Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group III: Ustekinumab 90 mg n=32 Participants Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group IV: Ustekinumab 45 mg Weekly for 4 Weeks n=37 Participants Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group V: Ustekinumab 90 mg Weekly for 4 Weeks n=47 Participants Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32	1 Particpants	8 Particpants	13 Particpants	15 Particpants	31 Particpants

SECONDARY outcome

Timeframe: Week 28

Population: Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.

Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.

Outcome measures

Measure	Group I: Placebo n=44 Participants Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.	Group II: Ustekinumab 45 mg n=28 Participants Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group III: Ustekinumab 90 mg n=28 Participants Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group IV: Ustekinumab 45 mg Weekly for 4 Weeks n=17 Participants Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 45 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.	Group V: Ustekinumab 90 mg Weekly for 4 Weeks n=10 Participants Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) \>=3 received 90 mg ustekinumab and participants with a PGA\<3 received placebo. At week 20, all participants received placebo.
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28	29 Participants	8 Participants	18 Participants	8 Participants	3 Participants

Adverse Events

Placebo (CP)

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Ustekinumab 45 mg (CP)

Serious events: 3 serious events

Other events: 38 other events

Deaths: 0 deaths

Ustekinumab 90 mg (CP)

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Ustekinumab 45 mg Weekly for 4 Weeks (CP)

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Ustekinumab 90 mg Weekly for 4 Weeks (CP)

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo -> Ustekinumab 90 mg (After CP)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Ustekinumab 45 mg (After CP)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Ustekinumab 90 mg (After CP)

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Ustekinumab 45 mg Weekly for 4 Weeks (After CP)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Ustekinumab 90 mg Weekly for 4 Weeks (After CP)

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (CP) n=67 participants at risk Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.	Ustekinumab 45 mg (CP) n=63 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg (CP) n=64 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Ustekinumab 45 mg Weekly for 4 Weeks (CP) n=63 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg Weekly for 4 Weeks (CP) n=62 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Placebo -> Ustekinumab 90 mg (After CP) n=49 participants at risk After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -\> receiving ustekinumab 90 mg at Week 20.	Ustekinumab 45 mg (After CP) n=60 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg (After CP) n=61 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Ustekinumab 45 mg Weekly for 4 Weeks (After CP) n=62 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg Weekly for 4 Weeks (After CP) n=62 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA \>= 3 received ustekinumab 90 mg.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Cardiac disorders Chest pain	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Injury, poisoning and procedural complications Injury	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Cardiac disorders Cardiac failure	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Congenital, familial and genetic disorders Hernia congenital	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Hepatobiliary disorders Hepatic enzymes increased	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	2.0% 1/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Vascular disorders Coronary artery disorder	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Cardiac disorders Myocardial infarction	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine fibroid	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Psychiatric disorders Drug dependence	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Psychiatric disorders Psychosis	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Infections and infestations Infection viral	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Skin and subcutaneous tissue disorders Psoriasis aggravated	1.5% 1/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Renal and urinary disorders Urinary tract infection	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Vascular disorders Cerebral infarction	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events

Other adverse events

Measure	Placebo (CP) n=67 participants at risk Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.	Ustekinumab 45 mg (CP) n=63 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg (CP) n=64 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Ustekinumab 45 mg Weekly for 4 Weeks (CP) n=63 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg Weekly for 4 Weeks (CP) n=62 participants at risk Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Placebo -> Ustekinumab 90 mg (After CP) n=49 participants at risk After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -\> receiving ustekinumab 90 mg at Week 20.	Ustekinumab 45 mg (After CP) n=60 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg (After CP) n=61 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA \>= 3 received ustekinumab 90 mg.	Ustekinumab 45 mg Weekly for 4 Weeks (After CP) n=62 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA \>= 3 received ustekinumab 45 mg.	Ustekinumab 90 mg Weekly for 4 Weeks (After CP) n=62 participants at risk After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA \>= 3 received ustekinumab 90 mg.
Blood and lymphatic system disorders Purpura	3.0% 2/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.3% 4/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	7.8% 5/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.1% 2/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.3% 4/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Injury, poisoning and procedural complications Injury	6.0% 4/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.7% 3/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.2% 2/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	2.0% 1/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.3% 2/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	8.2% 5/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Nervous system disorders Pain	3.0% 2/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	12.5% 8/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.5% 4/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	8.2% 4/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.3% 2/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.2% 2/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Nervous system disorders Headache	16.4% 11/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	19.0% 12/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	18.8% 12/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.2% 2/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	14.5% 9/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.3% 2/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.9% 3/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Gastrointestinal disorders Diarrhoea	0.00% 0/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.2% 4/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.3% 4/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.2% 2/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	2.0% 1/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.3% 2/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Gastrointestinal disorders Nausea	4.5% 3/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.2% 4/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.5% 4/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	2.0% 1/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.2% 2/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Musculoskeletal and connective tissue disorders Arthritis aggravated	7.5% 5/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Musculoskeletal and connective tissue disorders Myalgia	3.0% 2/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.3% 4/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.2% 4/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.3% 2/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Respiratory, thoracic and mediastinal disorders Pharyngitis	6.0% 4/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	7.9% 5/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.1% 2/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Respiratory, thoracic and mediastinal disorders Rhinitis	4.5% 3/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.3% 4/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	7.8% 5/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	7.9% 5/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	2.0% 1/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.2% 2/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Respiratory, thoracic and mediastinal disorders Sinusitis	4.5% 3/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.2% 4/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	2.0% 1/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	3.3% 2/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.6% 1/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	6.5% 4/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Respiratory, thoracic and mediastinal disorders Upper resp tract infection	20.9% 14/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	25.4% 16/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	31.2% 20/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	14.3% 9/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	17.7% 11/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	12.2% 6/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	16.7% 10/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	14.8% 9/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	8.1% 5/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	11.3% 7/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
Skin and subcutaneous tissue disorders Pruritus	3.0% 2/67 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	9.5% 6/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.7% 3/64 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	7.9% 5/63 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	4.8% 3/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/49 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	1.7% 1/60 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/61 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events	0.00% 0/62 • Week 36 Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events

Additional Information

Senior Director Clinical Research

Centocor Research & Development, Inc.

Phone: 1-800-457-6399

Results disclosure agreements

• Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER