Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis (NCT NCT01008995)

NCT ID: NCT01008995

Last Updated: 2013-11-11

Results Overview

Scores could range from 0 (mild) to 72 (severe).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 322 participants
• Primary outcome timeframe: Baseline (Week 0) to Week 12
• Results posted on: 2013-11-11

Participant Flow

Participant milestones

Measure	Placebo (CP) Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) Controlled period (Week 0-12) - Ustekinumab 45 mg Group	Placebo -> Ustekinumab 45 mg (After CP) After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16	Ustekinumab 45 mg (After CP) After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
Controlled Period STARTED	162	160	0	0
Controlled Period COMPLETED	159	157	0	0
Controlled Period NOT COMPLETED	3	3	0	0
After Controlled Period STARTED	0	0	158	157
After Controlled Period COMPLETED	0	0	156	156
After Controlled Period NOT COMPLETED	0	0	2	1

Reasons for withdrawal

Measure	Placebo (CP) Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) Controlled period (Week 0-12) - Ustekinumab 45 mg Group	Placebo -> Ustekinumab 45 mg (After CP) After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16	Ustekinumab 45 mg (After CP) After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
Controlled Period Adverse Event	1	2	0	0
Controlled Period Other	2	1	0	0
After Controlled Period Adverse Event	0	0	1	1
After Controlled Period Other	0	0	1	0

Baseline Characteristics

A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis

Baseline characteristics by cohort

Measure	Placebo (CP) n=162 Participants Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) n=160 Participants Controlled period (Week 0-12) - Ustekinumab 45 mg Group	Total n=322 Participants Total of all reporting groups
Age Continuous	39.2 years STANDARD_DEVIATION 12.21 • n=5 Participants	40.1 years STANDARD_DEVIATION 12.36 • n=7 Participants	39.7 years STANDARD_DEVIATION 12.28 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	35 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	125 Participants n=7 Participants	248 Participants n=5 Participants
Region of Enrollment China	162 participants n=5 Participants	160 participants n=7 Participants	322 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) to Week 12

Population: All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received.

Scores could range from 0 (mild) to 72 (severe).

Outcome measures

Measure	Placebo (CP) n=162 Participants Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) n=160 Participants Controlled period (Week 0-12) - Ustekinumab 45 mg Group
The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.	18 Participants	132 Participants

SECONDARY outcome

Timeframe: Week 12

Population: All participants were included and analyzed according to their randomized treatment group.

Outcome measures

Measure	Placebo (CP) n=162 Participants Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) n=160 Participants Controlled period (Week 0-12) - Ustekinumab 45 mg Group
The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12	24 Participants	126 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 12

Population: Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group.

Scores could range from 0 to 30. A lower DLQI score represents better quality of life.

Outcome measures

Measure	Placebo (CP) n=159 Participants Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) n=158 Participants Controlled period (Week 0-12) - Ustekinumab 45 mg Group
The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.	-1.9 Score Standard Deviation 6.63	-9.3 Score Standard Deviation 7.18

Adverse Events

Placebo (CP)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Ustekinumab 45 mg (CP)

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo -> Ustekinumab 45 mg (After CP)

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Ustekinumab 45 mg (After CP)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (CP) n=161 participants at risk Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) n=160 participants at risk Controlled period (Week 0-12) - Ustekinumab 45 mg Group	Placebo -> Ustekinumab 45 mg (After CP) n=158 participants at risk After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16	Ustekinumab 45 mg (After CP) n=159 participants at risk After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/161 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.62% 1/160 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/158 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/159 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.
Injury, poisoning and procedural complications Hand fracture	0.62% 1/161 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/160 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/158 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/159 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.
Injury, poisoning and procedural complications Head injury	0.00% 0/161 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/160 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/158 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.63% 1/159 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/161 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/160 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.63% 1/158 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/159 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/161 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/160 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.63% 1/158 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	0.00% 0/159 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.

Other adverse events

Measure	Placebo (CP) n=161 participants at risk Controlled period (Week 0-12) - Placebo Group	Ustekinumab 45 mg (CP) n=160 participants at risk Controlled period (Week 0-12) - Ustekinumab 45 mg Group	Placebo -> Ustekinumab 45 mg (After CP) n=158 participants at risk After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16	Ustekinumab 45 mg (After CP) n=159 participants at risk After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
Infections and infestations Nasopharyngitis	8.1% 13/161 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	11.9% 19/160 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	9.5% 15/158 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	4.4% 7/159 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.
Infections and infestations Upper respiratory tract infection	5.0% 8/161 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	5.6% 9/160 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	7.6% 12/158 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.	4.4% 7/159 One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.

Additional Information

Director, Clinical Research

Janssen R&D US

Phone: 1 215-793-7646

Results disclosure agreements

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

Restriction type: LTE60