Trial Outcomes & Findings for A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy (NCT NCT00771667)

NCT ID: NCT00771667

Last Updated: 2013-04-01

Results Overview

As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 526 participants
• Primary outcome timeframe: Baseline to Week 6
• Results posted on: 2013-04-01

Participant Flow

Participant milestones

Measure	Placebo (IP) Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group	Placebo IV -> Responder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16	Ustekinumab IV -> Responder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Induction Phase STARTED	132	131	132	131	0	0	0	0	0	0
Induction Phase COMPLETED	113	121	120	123	0	0	0	0	0	0
Induction Phase NOT COMPLETED	19	10	12	8	0	0	0	0	0	0
Maintenance Phase STARTED	0	0	0	0	28	85	73	72	110	109
Maintenance Phase COMPLETED	0	0	0	0	26	78	63	67	88	92
Maintenance Phase NOT COMPLETED	0	0	0	0	2	7	10	5	22	17

Reasons for withdrawal

Measure	Placebo (IP) Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group	Placebo IV -> Responder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16	Ustekinumab IV -> Responder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Induction Phase Adverse Event	5	2	4	1	0	0	0	0	0	0
Induction Phase Lack of Efficacy	9	2	4	3	0	0	0	0	0	0
Induction Phase Lost to Follow-up	1	0	1	0	0	0	0	0	0	0
Induction Phase Other	4	6	3	4	0	0	0	0	0	0
Maintenance Phase Adverse Event	0	0	0	0	1	3	5	1	8	7
Maintenance Phase Lack of Efficacy	0	0	0	0	1	3	3	2	11	7
Maintenance Phase Other	0	0	0	0	0	1	2	2	3	3

Baseline Characteristics

A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

Baseline characteristics by cohort

Measure	Placebo (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group	Total n=526 Participants Total of all reporting groups
Age Continuous	39.5 years STANDARD_DEVIATION 13.05 • n=5 Participants	38.8 years STANDARD_DEVIATION 11.95 • n=7 Participants	38.2 years STANDARD_DEVIATION 12.63 • n=5 Participants	39.4 years STANDARD_DEVIATION 13.21 • n=4 Participants	39 years STANDARD_DEVIATION 12.69 • n=21 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	83 Participants n=7 Participants	75 Participants n=5 Participants	83 Participants n=4 Participants	309 Participants n=21 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	48 Participants n=7 Participants	57 Participants n=5 Participants	48 Participants n=4 Participants	217 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 6

Population: All participants who were randomized, regardless of whether they received study agent.

As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.

Outcome measures

Measure	Placebo (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Number of Participants With Clinical Response at Week 6	31 Participants	48 Participants	45 Participants	52 Participants

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: All participants who were randomized, regardless of whether they received study agent.

As measured by a CDAI score of < 150 points.

Outcome measures

Measure	Placebo (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Number of Participants With Clinical Remission at Week 6	14 Participants	21 Participants	21 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: All participants who were randomized, regardless of whether they received study agent.

As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.

Outcome measures

Measure	Placebo (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Number of Participants With Clinical Response at Week 4	22 Participants	36 Participants	49 Participants	40 Participants

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: All participants who were randomized, regardless of whether they received study agent.

As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.

Outcome measures

Measure	Placebo (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Number of Participants With Clinical Response at Week 8	23 Participants	42 Participants	42 Participants	57 Participants

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: All participants who were randomized, regardless of whether they received study agent.

As measured by a CDAI score of < 150 points.

Outcome measures

Measure	Placebo (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=132 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Number of Participants With Clinical Remission at Week 8	14 Participants	23 Participants	24 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline to Week 22

Population: All participants who were randomized, regardless of whether they received study agent.

As measured by a CDAI score of < 150 points.

Outcome measures

Measure	Placebo (IP) n=73 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=72 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)	20 Participants	30 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 22

Population: All participants who were randomized, regardless of whether they received study agent.

As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.

Outcome measures

Measure	Placebo (IP) n=73 Participants Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=72 Participants Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)	31 Participants	50 Participants	—	—

Adverse Events

Placebo (IP)

Serious events: 11 serious events

Other events: 53 other events

Deaths: 0 deaths

Ustekinumab 1 mg/kg (IP)

Serious events: 6 serious events

Other events: 51 other events

Deaths: 0 deaths

Ustekinumab 3 mg/kg (IP)

Serious events: 8 serious events

Other events: 50 other events

Deaths: 0 deaths

Ustekinumab 6 mg/kg (IP)

Serious events: 9 serious events

Other events: 47 other events

Deaths: 0 deaths

Placebo IV -> Responder -> Placebo SC (MP)

Serious events: 8 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)

Serious events: 16 serious events

Other events: 47 other events

Deaths: 0 deaths

Ustekinumab IV -> Responder -> Placebo SC (MP)

Serious events: 12 serious events

Other events: 39 other events

Deaths: 0 deaths

Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)

Serious events: 9 serious events

Other events: 39 other events

Deaths: 0 deaths

Ustekinumab IV -> Nonresponder -> Placebo SC (MP)

Serious events: 21 serious events

Other events: 64 other events

Deaths: 0 deaths

Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)

Serious events: 22 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (IP) n=132 participants at risk Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=130 participants at risk Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=133 participants at risk Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 participants at risk Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group	Placebo IV -> Responder -> Placebo SC (MP) n=28 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP) n=85 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16	Ustekinumab IV -> Responder -> Placebo SC (MP) n=73 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP) n=72 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Placebo SC (MP) n=110 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP) n=109 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Blood and lymphatic system disorders Anaemia	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Gastrointestinal disorders Abdominal hernia	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Gastrointestinal disorders Abdominal mass	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Abdominal pain	0.00% 0/132	0.00% 0/130	0.75% 1/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	1.4% 1/73	0.00% 0/72	0.91% 1/110	2.8% 3/109
Gastrointestinal disorders Anal stenosis	0.00% 0/132	0.00% 0/130	0.75% 1/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Constipation	0.76% 1/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	3.6% 1/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Crohn's disease	3.8% 5/132	1.5% 2/130	3.0% 4/133	1.5% 2/131	10.7% 3/28	9.4% 8/85	9.6% 7/73	5.6% 4/72	7.3% 8/110	9.2% 10/109
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Gastrointestinal disorders Enterovesical fistula	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Gastrointestinal disorders Gastritis	0.00% 0/132	0.00% 0/130	0.75% 1/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Ileal stenosis	0.00% 0/132	0.00% 0/130	0.75% 1/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Intestinal obstruction	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Gastrointestinal disorders Intestinal stenosis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Gastrointestinal disorders Pancreatitis	0.76% 1/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Pancreatitis acute	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Gastrointestinal disorders Proctalgia	0.00% 0/132	0.77% 1/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	1.4% 1/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Rectal discharge	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/132	0.77% 1/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Small intestinal obstruction	0.76% 1/132	0.00% 0/130	0.75% 1/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
General disorders Asthenia	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
General disorders Fatigue	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
General disorders Hernia	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
General disorders Impaired healing	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
General disorders Malaise	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	1.4% 1/72	0.00% 0/110	0.00% 0/109
General disorders Oedema peripheral	0.76% 1/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
General disorders Pyrexia	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Hepatobiliary disorders Bile duct stone	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Hepatobiliary disorders Biliary colic	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	1.4% 1/72	0.00% 0/110	0.00% 0/109
Hepatobiliary disorders Cholecystitis acute	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Hepatobiliary disorders Cholelithiasis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Immune system disorders Serum sickness-like reaction	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Infections and infestations Abdominal abscess	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	1.8% 2/110	0.00% 0/109
Infections and infestations Anal abscess	1.5% 2/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	1.4% 1/72	0.00% 0/110	0.00% 0/109
Infections and infestations Beta haemolytic streptococcal infection	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Campylobacter infection	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Infections and infestations Clostridial infection	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Gastroenteritis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Infections and infestations Gastroenteritis viral	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Gastrointestinal infection	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Perirectal abscess	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	3.6% 1/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Pneumonia	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Infections and infestations Postoperative abscess	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	1.4% 1/72	0.00% 0/110	0.00% 0/109
Infections and infestations Rectal abscess	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Infections and infestations Respiratory tract infection	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Staphylococcal infection	0.00% 0/132	0.77% 1/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Upper respiratory tract infection	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Urinary tract infection bacterial	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Infections and infestations Vaginal abscess	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Injury, poisoning and procedural complications Hand fracture	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	1.4% 1/72	0.00% 0/110	0.00% 0/109
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.76% 1/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Injury, poisoning and procedural complications Seroma	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Investigations International normalised ratio increased	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Metabolism and nutrition disorders Decreased appetite	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	3.6% 1/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Metabolism and nutrition disorders Dehydration	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.92% 1/109
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	1.4% 1/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Metabolism and nutrition disorders Iron deficiency	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Musculoskeletal and connective tissue disorders Arthralgia	0.76% 1/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	3.6% 1/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Nervous system disorders Headache	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Nervous system disorders Syncope	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.92% 1/109
Nervous system disorders VIIth nerve paralysis	0.00% 0/132	0.00% 0/130	0.75% 1/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Psychiatric disorders Conversion disorder	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Psychiatric disorders Psychiatric decompensation	0.76% 1/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Psychiatric disorders Somatoform disorder	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.92% 1/109
Psychiatric disorders Suicidal ideation	0.00% 0/132	0.77% 1/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Renal and urinary disorders Acute prerenal failure	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Renal and urinary disorders Nephrolithiasis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	1.4% 1/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Renal and urinary disorders Renal colic	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.91% 1/110	0.00% 0/109
Reproductive system and breast disorders Ovarian cyst	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	3.6% 1/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.76% 1/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.76% 1/131	0.00% 0/28	0.00% 0/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109
Vascular disorders Deep vein thrombosis	0.00% 0/132	0.00% 0/130	0.00% 0/133	0.00% 0/131	0.00% 0/28	1.2% 1/85	0.00% 0/73	0.00% 0/72	0.00% 0/110	0.00% 0/109

Other adverse events

Measure	Placebo (IP) n=132 participants at risk Induction phase (Week 0-8) (IP) - Placebo IV group	Ustekinumab 1 mg/kg (IP) n=130 participants at risk Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group	Ustekinumab 3 mg/kg (IP) n=133 participants at risk Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group	Ustekinumab 6 mg/kg (IP) n=131 participants at risk Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group	Placebo IV -> Responder -> Placebo SC (MP) n=28 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP) n=85 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16	Ustekinumab IV -> Responder -> Placebo SC (MP) n=73 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP) n=72 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Responder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Placebo SC (MP) n=110 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Placebo SC at Week 8 and Week 16	Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP) n=109 participants at risk Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\> Nonresponder at week 6 -\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Gastrointestinal disorders Abdominal pain	6.8% 9/132	3.8% 5/130	6.0% 8/133	5.3% 7/131	3.6% 1/28	4.7% 4/85	11.0% 8/73	4.2% 3/72	9.1% 10/110	6.4% 7/109
Gastrointestinal disorders Crohn's disease	6.1% 8/132	3.8% 5/130	2.3% 3/133	2.3% 3/131	35.7% 10/28	10.6% 9/85	21.9% 16/73	9.7% 7/72	17.3% 19/110	9.2% 10/109
Gastrointestinal disorders Diarrhoea	1.5% 2/132	0.00% 0/130	1.5% 2/133	1.5% 2/131	3.6% 1/28	0.00% 0/85	5.5% 4/73	2.8% 2/72	4.5% 5/110	1.8% 2/109
Gastrointestinal disorders Nausea	8.3% 11/132	6.9% 9/130	0.75% 1/133	6.1% 8/131	10.7% 3/28	9.4% 8/85	6.8% 5/73	9.7% 7/72	7.3% 8/110	3.7% 4/109
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/132	1.5% 2/130	0.00% 0/133	0.76% 1/131	7.1% 2/28	1.2% 1/85	2.7% 2/73	1.4% 1/72	0.00% 0/110	0.00% 0/109
Gastrointestinal disorders Vomiting	2.3% 3/132	1.5% 2/130	2.3% 3/133	2.3% 3/131	0.00% 0/28	2.4% 2/85	5.5% 4/73	8.3% 6/72	5.5% 6/110	4.6% 5/109
General disorders Fatigue	0.00% 0/132	2.3% 3/130	3.0% 4/133	0.76% 1/131	0.00% 0/28	2.4% 2/85	6.8% 5/73	2.8% 2/72	3.6% 4/110	0.92% 1/109
General disorders Pyrexia	2.3% 3/132	3.8% 5/130	3.0% 4/133	2.3% 3/131	3.6% 1/28	9.4% 8/85	2.7% 2/73	1.4% 1/72	8.2% 9/110	5.5% 6/109
Infections and infestations Nasopharyngitis	4.5% 6/132	5.4% 7/130	5.3% 7/133	6.1% 8/131	3.6% 1/28	14.1% 12/85	8.2% 6/73	6.9% 5/72	0.00% 0/110	5.5% 6/109
Infections and infestations Sinusitis	1.5% 2/132	1.5% 2/130	0.75% 1/133	1.5% 2/131	3.6% 1/28	1.2% 1/85	4.1% 3/73	5.6% 4/72	4.5% 5/110	3.7% 4/109
Infections and infestations Upper respiratory tract infection	0.00% 0/132	3.8% 5/130	3.0% 4/133	3.8% 5/131	7.1% 2/28	2.4% 2/85	5.5% 4/73	8.3% 6/72	6.4% 7/110	6.4% 7/109
Infections and infestations Urinary tract infection	2.3% 3/132	1.5% 2/130	0.75% 1/133	0.76% 1/131	7.1% 2/28	1.2% 1/85	0.00% 0/73	4.2% 3/72	5.5% 6/110	4.6% 5/109
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 4/132	6.2% 8/130	6.0% 8/133	4.6% 6/131	7.1% 2/28	8.2% 7/85	4.1% 3/73	6.9% 5/72	10.9% 12/110	4.6% 5/109
Musculoskeletal and connective tissue disorders Back pain	2.3% 3/132	3.8% 5/130	3.0% 4/133	3.1% 4/131	7.1% 2/28	2.4% 2/85	4.1% 3/73	4.2% 3/72	5.5% 6/110	0.92% 1/109
Nervous system disorders Dizziness	1.5% 2/132	1.5% 2/130	4.5% 6/133	2.3% 3/131	0.00% 0/28	1.2% 1/85	5.5% 4/73	2.8% 2/72	2.7% 3/110	0.92% 1/109
Nervous system disorders Headache	6.1% 8/132	6.2% 8/130	6.8% 9/133	9.9% 13/131	3.6% 1/28	5.9% 5/85	5.5% 4/73	5.6% 4/72	6.4% 7/110	7.3% 8/109
Respiratory, thoracic and mediastinal disorders Cough	2.3% 3/132	4.6% 6/130	3.0% 4/133	2.3% 3/131	14.3% 4/28	2.4% 2/85	5.5% 4/73	1.4% 1/72	2.7% 3/110	3.7% 4/109
Skin and subcutaneous tissue disorders Rash	1.5% 2/132	0.77% 1/130	4.5% 6/133	2.3% 3/131	3.6% 1/28	1.2% 1/85	2.7% 2/73	1.4% 1/72	4.5% 5/110	5.5% 6/109

Additional Information

Director, Clinical Research

Janssen Research and Development, US

Phone: 610-651-6554

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60