Trial · NCT01009086
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
NCT01009086, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2014-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis. Trials, record NCT01009086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01009086
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
- NCT number
- NCT01009086
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 615 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Arthritis, Psoriatic
- Interventions
- Placebo, Ustekinumab 45 mg, Ustekinumab 90 mg
- First posted
- 2009-11-06
- Last updated
- 2015-03-03
- Other registries' IDs
- eudract:2009-012264-14
- Results first posted
- 2014-03-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. | Week 24 | An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters \[cm\]) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein. |
| Secondary | Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) | Day 1 (Baseline) and Week 24 | The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement. |
| Secondary | Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 | Week 24 | The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline. |
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 | Week 24 | An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein. |
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24 | Week 24 | An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein. |
| Secondary | Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002 | Day 1 (Baseline) and Week 24 | The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. | Week 24 | All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI) | Day 1 (Baseline) and Week 24 | All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 | Week 24 | All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with \>=3% baseline BSA psoriatic involvement were included in this analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 | Week 24 | All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24 | Week 24 | All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002 | Day 1 (Baseline) and Week 24 | Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. | Placebo | 22.8 | Percentage of participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. | Ustekinumab 45 mg | 42.4 | Percentage of participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. | Ustekinumab 90 mg | 49.5 | Percentage of participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. | All Ustekinumab Combined | 46.0 | Percentage of participants | ||
| Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI) | Placebo | -0.10 | Standard Deviation 0.390 | Score on a scale | |
| Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI) | Ustekinumab 45 mg | -0.31 | Standard Deviation 0.521 | Score on a scale | |
| Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI) | Ustekinumab 90 mg | -0.40 | Standard Deviation 0.514 | Score on a scale | |
| Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI) | All Ustekinumab Combined | -0.36 | Standard Deviation 0.518 | Score on a scale | |
| Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 | Placebo | 11.0 | Percentage of participants | ||
| Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 | Ustekinumab 45 mg | 57.2 | Percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: PLACEBO | 206 | |
| Overall Study | STARTED | Group 2: USTEKINUMAB 45 MG | 205 | |
| Overall Study | STARTED | Group 3: USTEKINUMAB 90 MG | 204 | |
| Overall Study | COMPLETED | Group 1: PLACEBO | 162 | |
| Overall Study | COMPLETED | Group 2: USTEKINUMAB 45 MG | 158 | |
| Overall Study | COMPLETED | Group 3: USTEKINUMAB 90 MG | 170 | |
| Overall Study | NOT COMPLETED | Group 1: PLACEBO | 44 | |
| Overall Study | NOT COMPLETED | Group 2: USTEKINUMAB 45 MG | 47 | |
| Overall Study | NOT COMPLETED | Group 3: USTEKINUMAB 90 MG | 34 |
Source ClinicalTrials.gov
Adverse events490
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 | Nasopharyngitis | Infections and infestations | Placebo (CP) | 8 | 205 | |
| other | Nasopharyngitis | Infections and infestations | Ustekinumab 45 mg (CP) | 8 | 205 | |
| other | Nasopharyngitis | Infections and infestations | Ustekinumab 90 mg (CP) | 11 | 204 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (After CP) | 2 | 140 | |
| other | Nasopharyngitis | Infections and infestations | Placebo -> Ustekinumab 45 mg (After CP) | 15 | 189 | |
| other | Nasopharyngitis | Infections and infestations | Ustekinumab 45 mg (After CP) | 18 | 203 | |
| other | Nasopharyngitis | Infections and infestations | Ustekinumab 90 mg (After CP) | 20 | 199 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo (CP) | 10 | 205 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Ustekinumab 45 mg (CP) | 5 | 205 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Ustekinumab 90 mg (CP) | 9 | 204 |
1 to 10 of 490Source ClinicalTrials.gov
See all 490 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 (After CP) | ||
| Total, all-cause mortality | Placebo -> Ustekinumab 45 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) | 30 | 205 |
| Total, other adverse events | Ustekinumab 45 mg (CP) | 17 | 205 |
| Total, other adverse events | Ustekinumab 90 mg (CP) | 29 | 204 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers8
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
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