Trial · NCT01387815
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
NCT01387815, Completed, AbbVie (prior sponsor, Abbott); results first posted 2019-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis. Trials, record NCT01387815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01387815
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
- NCT number
- NCT01387815
- Status
- Completed
- Enrollment
- 662 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Psoriasis
- Interventions
- Adalimumab
- First posted
- 2011-07-06
- Last updated
- 2019-12-05
- Results first posted
- 2019-12-05
Source ClinicalTrials.gov
Registered outcomes145
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 | Month 6 | The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit. |
| Secondary | Time to Achieving PGA ≤ 1 | Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24 | The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. |
| Secondary | PGA≤1: Percentage of Participants at Month 3 | Month 3 | The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit. |
| Secondary | PGA≤1: Percentage of Participants at Month 12 | Month 12 | The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit. |
| Secondary | PGA≤1: Percentage of Participants at Month 18 | Month 18 | The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit. |
| Secondary | PGA≤1: Percentage of Participants at Month 24 | Month 24 | The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit. |
| Secondary | Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3 | Baseline, Month 3 | PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement. |
| Secondary | PASQ Total Score: Change From Baseline to Month 6 | Baseline, Month 6 | PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement. |
| Secondary | PASQ Total Score: Change From Baseline to Month 12 | Baseline, Month 12 | PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement. |
| Secondary | PASQ Total Score: Change From Baseline to Month 18 | Baseline, Month 18 | PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement. |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 registered outcomesOutcomes145
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 a Physician Global Assessment (PGA) Score ≤1 at Month 6 | Month 6 | ITT population: all participants who signed informed consent, met inclusion/exclusion criteria, and received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Time to Achieving PGA ≤ 1 | Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24 | ITT population | Months | MEDIAN |
| SECONDARY | PGA≤1: Percentage of Participants at Month 3 | Month 3 | ITT population | percentage of participants | NUMBER |
| SECONDARY | PGA≤1: Percentage of Participants at Month 12 | Month 12 | ITT population | percentage of participants | NUMBER |
| SECONDARY | PGA≤1: Percentage of Participants at Month 18 | Month 18 | ITT population | percentage of participants | NUMBER |
| SECONDARY | PGA≤1: Percentage of Participants at Month 24 | Month 24 | ITT population | percentage of participants | NUMBER |
| SECONDARY | Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3 | Baseline, Month 3 | ITT population of participants who were available for assessment at this visit. | score on a scale | MEAN |
| SECONDARY | PASQ Total Score: Change From Baseline to Month 6 | Baseline, Month 6 | ITT population of participants who were available for assessment at this visit. | score on a scale | MEAN |
| SECONDARY | PASQ Total Score: Change From Baseline to Month 12 | Baseline, Month 12 | ITT population of participants who were available for assessment at this visit. | score on a scale | MEAN |
| SECONDARY | PASQ Total Score: Change From Baseline to Month 18 | Baseline, Month 18 | ITT population of participants who were available for assessment at this visit. | score on a scale | MEAN |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 outcomesResults by group523
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 a Physician Global Assessment (PGA) Score ≤1 at Month 6 | Topical/Traditional Systemic Agent | 31.4 | percentage of participants | ||
| Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 | Adalimumab | 56.3 | percentage of participants | ||
| Time to Achieving PGA ≤ 1 | Topical/Traditional Systemic Agent | 13.3 | 95% Confidence Interval 11.8 to 22.0 | Months | |
| Time to Achieving PGA ≤ 1 | Adalimumab | 5.7 | 95% Confidence Interval 4.4 to 6.0 | Months | |
| PGA≤1: Percentage of Participants at Month 3 | Topical/Traditional Systemic Agent | 19.0 | percentage of participants | ||
| PGA≤1: Percentage of Participants at Month 3 | Adalimumab | 47.5 | percentage of participants | ||
| PGA≤1: Percentage of Participants at Month 12 | Topical/Traditional Systemic Agent | 34.5 | percentage of participants | ||
| PGA≤1: Percentage of Participants at Month 12 | Adalimumab | 57.3 | percentage of participants | ||
| PGA≤1: Percentage of Participants at Month 18 | Topical/Traditional Systemic Agent | 35.7 | percentage of participants | ||
| PGA≤1: Percentage of Participants at Month 18 | Adalimumab | 61.3 | percentage of participants |
1 to 10 of 523Source ClinicalTrials.gov
See all 523 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topical/Traditional Systemic Agent | 302 | |
| Overall Study | STARTED | Adalimumab | 293 | |
| Overall Study | COMPLETED | Topical/Traditional Systemic Agent | 162 | |
| Overall Study | COMPLETED | Adalimumab | 189 | |
| Overall Study | NOT COMPLETED | Topical/Traditional Systemic Agent | 140 | |
| Overall Study | NOT COMPLETED | Adalimumab | 104 |
Source ClinicalTrials.gov
Adverse events134
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 | SENSITIVITY OF TEETH | Gastrointestinal disorders | Topical/Traditional | 0 | 330 | 0 |
| other | SENSITIVITY OF TEETH | Gastrointestinal disorders | Adalimumab | 1 | 328 | 1 |
| other | DRUG INEFFECTIVE | General disorders | Topical/Traditional | 1 | 330 | 1 |
| other | DRUG INEFFECTIVE | General disorders | Adalimumab | 8 | 328 | 10 |
| other | INJECTION SITE REACTION | General disorders | Topical/Traditional | 0 | 330 | 0 |
| other | INJECTION SITE REACTION | General disorders | Adalimumab | 1 | 328 | 2 |
| other | PAIN | General disorders | Topical/Traditional | 0 | 330 | 0 |
| other | PAIN | General disorders | Adalimumab | 1 | 328 | 1 |
| other | HERPES ZOSTER | Infections and infestations | Topical/Traditional | 0 | 330 | 0 |
| other | HERPES ZOSTER | Infections and infestations | Adalimumab | 1 | 328 | 1 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topical/Traditional | 0 | 330 |
| Total, all-cause mortality | Adalimumab | 1 | 328 |
| Total, other adverse events | Topical/Traditional | 1 | 330 |
| Total, other adverse events | Adalimumab | 14 | 328 |
| Total, serious adverse events | Topical/Traditional | 2 | 330 |
| Total, serious adverse events | Adalimumab | 23 | 328 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topical/Traditional Systemic Agent vs Adalimumab: HCRU: Number of Participants With Insurance for Prescription Medication at Month 12 | Trial comparisons |
| Topical/Traditional Systemic Agent vs Adalimumab: Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6 | Trial comparisons |
| Topical/Traditional Systemic Agent vs Adalimumab: HCRU: Number of Participants With Insurance for Prescription Medication at Month 24 | Trial comparisons |
| Topical/Traditional vs Adalimumab: deaths from any cause | Trial comparisons |
| Topical/Traditional vs Adalimumab: serious adverse events | Trial comparisons |
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.
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