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| ID | Type | Description | Link |
|---|---|---|---|
| C0743T23 | Other Identifier | Centocor | |
| CR016318 | Other Identifier | Centocor |
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The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.
In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. Group 2 will receive ustekinumab 45 mg at Weeks 0, 4, and 16 and placebo at Week 12. All patients in the study will eventually receive ustekinumab after Week 12. The patients will be in the study for about 36 weeks, with study visit approximately 10 times. Effectiveness evaluations will be conducted throughout the study and include the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Safety assessments will also be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure) and the occurrence and severity of adverse events. GROUP 1: Placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. GROUP 2: Ustekinumab 45 mg at Weeks 0, 4, and 16. Placebo at Week 12
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16 |
|
| 002 | Experimental | placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Subcutaneous injection at Week 0 and 4 |
| |
| ustekinumab |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. | Scores could range from 0 (mild) to 72 (severe). | Baseline (Week 0) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Week 12 | |
| The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. | Scores could range from 0 to 30. A lower DLQI score represents better quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (CP) | Controlled period (Week 0-12) - Placebo Group |
| FG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg Group |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Controlled Period |
|
| ||||||||||||||||||
| After Controlled Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (CP) | Controlled period (Week 0-12) - Placebo Group |
| BG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. | Scores could range from 0 (mild) to 72 (severe). | All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received. | Posted | Number | Participants | Baseline (Week 0) to Week 12 |
|
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One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (CP) | Controlled period (Week 0-12) - Placebo Group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Janssen R&D US | 1 215-793-7646 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
45 mg subcutaneous injection at Week 12 and 16 |
|
| placebo | Drug | Subcutaneous injection at Week 12 |
|
| ustekinumab | Drug | 45 mg subcutaneous injection at Week 0, 4 and 16 |
|
| Baseline (Week 0) to Week 12 |
| Chongqing |
| China |
| Dalian | China |
| Guangzhou | China |
| Hangzhou | China |
| Nanjing | China |
| Shanghai | China |
| Shenyang | China |
| Xi'an | China |
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | All participants were included and analyzed according to their randomized treatment group. | Posted | Number | Participants | Week 12 |
|
|
|
|
| Secondary | The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. | Scores could range from 0 to 30. A lower DLQI score represents better quality of life. | Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group. | Posted | Mean | Standard Deviation | Score | Baseline (Week 0) to Week 12 |
|
|
|
|
| 1 |
| 161 |
| 21 |
| 161 |
| EG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg Group | 1 | 160 | 28 | 160 |
| EG002 | 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 | 2 | 158 | 27 | 158 |
| EG003 | 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 | 1 | 159 | 14 | 159 |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |