Trial · NCT00267969
A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
NCT00267969, Phase 3, Completed, Centocor Research & Development, Inc.; results first posted 2012-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis. Trials, record NCT00267969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00267969
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
- NCT number
- NCT00267969
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 766 participants, actual
- Lead sponsor
- Centocor Research & Development, Inc.
- Conditions
- Psoriasis
- Interventions
- ustekinumab, placebo
- First posted
- 2005-12-22
- Last updated
- 2013-06-17
- Other registries' IDs
- eudract:2005-003529-15
- Results first posted
- 2012-08-24
- Limitations and caveats
The count of patients with any nonserious adverse event (NAE) excludes patients who only had NAE that occured in \<=5% of patients. This information may vary from existing approved labeling and publications due to the requirements of this website.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. | Week 12 | The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \[best\] - 72 \[worst\]) 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. |
| Secondary | Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Week 12 | The PGA is used to determine the participant's psoriasis lesions overall at a given time point. Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 \[best\] to 5 \[worst\]. |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 | Baseline (Week 0), Week 12 | Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12. This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life). |
| Secondary | Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52 | Week 52 | The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \[best\] - 72 \[worst\]) at Week 52 in participants randomly assigned to a treatment group at Week 40. 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. | Week 12 | Intent to treat. All patients randomized were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Week 12 | Intent to treat. All patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12. | participants | NUMBER |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 | Baseline (Week 0), Week 12 | Patients were included in the analysis according to the assigned treatment groups. Zero change is imputed if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed. | Scores on a scale | MEDIAN |
| SECONDARY | Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52 | Week 52 | Patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. | Placebo | 8 | Participants | ||
| Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. | Ustekinumab 45 mg | 171 | Participants | ||
| Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. | Ustekinumab 90 mg | 170 | Participants | ||
| Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Placebo | 10 | participants | ||
| Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Ustekinumab 45 mg | 151 | participants | ||
| Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Ustekinumab 90 mg | 156 | participants | ||
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 | Placebo | 0.0 | Inter-Quartile Range -3.0 to 3.0 | Scores on a scale | |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 | Ustekinumab 45 mg | -6.0 | Inter-Quartile Range -12.0 to -3.0 | Scores on a scale | |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 | Ustekinumab 90 mg | -7.0 | Inter-Quartile Range -12.0 to -4.0 | Scores on a scale | |
| Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52 | Group 1: Ustekinumab 45 mg Withdrawal Group | 47 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Controlled Period | STARTED | Placebo (CP) | 255 | |
| Controlled Period | STARTED | Ustekinumab 45 mg (CP) | 255 | |
| Controlled Period | STARTED | Ustekinumab 90 mg (CP) | 256 | |
| Controlled Period | STARTED | Placebo -> Ustekinumab 45 mg (After CP) | 0 | |
| Controlled Period | STARTED | Placebo -> Ustekinumab 90 mg (After CP) | 0 | |
| Controlled Period | STARTED | Ustekinumab 45 mg (After CP) | 0 | |
| Controlled Period | STARTED | Ustekinumab 90 mg (After CP) | 0 | |
| Controlled Period | COMPLETED | Placebo (CP) | 243 | |
| Controlled Period | COMPLETED | Ustekinumab 45 mg (CP) | 254 | |
| Controlled Period | COMPLETED | Ustekinumab 90 mg (CP) | 245 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,078
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Placebo (CP) | 2 | 255 | |
| other | Abdominal pain | Gastrointestinal disorders | Ustekinumab 45 mg (CP) | 0 | 255 | |
| other | Abdominal pain | Gastrointestinal disorders | Ustekinumab 90 mg (CP) | 1 | 255 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo -> Ustekinumab 45 mg (After CP) | 1 | 123 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo -> Ustekinumab 90 mg (After CP) | 3 | 120 | |
| other | Abdominal pain | Gastrointestinal disorders | Ustekinumab 45 mg (After CP) | 13 | 255 | |
| other | Abdominal pain | Gastrointestinal disorders | Ustekinumab 90 mg (After CP) | 8 | 251 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (CP) | 1 | 255 | |
| other | Diarrhoea | Gastrointestinal disorders | Ustekinumab 45 mg (CP) | 4 | 255 | |
| other | Diarrhoea | Gastrointestinal disorders | Ustekinumab 90 mg (CP) | 2 | 255 |
1 to 10 of 1,078Source ClinicalTrials.gov
See all 1,078 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (CP) | ||
| Total, all-cause mortality | Ustekinumab 45 mg (CP) | ||
| Total, all-cause mortality | Ustekinumab 90 mg (CP) | ||
| Total, all-cause mortality | Placebo -> Ustekinumab 45 mg (After CP) | ||
| Total, all-cause mortality | Placebo -> Ustekinumab 90 mg (After CP) | ||
| Total, all-cause mortality | Ustekinumab 45 mg (After CP) | ||
| Total, all-cause mortality | Ustekinumab 90 mg (After CP) | ||
| Total, other adverse events | Placebo (CP) | 81 | 255 |
| Total, other adverse events | Ustekinumab 45 mg (CP) | 102 | 255 |
| Total, other adverse events | Ustekinumab 90 mg (CP) | 84 | 255 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00267969
GET https://conductscience.org/api/trials/v1/NCT00267969/flow?page=2