Trial · NCT00322439
Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
NCT00322439, Completed, Amgen; results first posted 2014-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis. Trials, record NCT00322439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00322439
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
- NCT number
- NCT00322439
- Status
- Completed
- Enrollment
- 2,511 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Psoriasis
- Interventions
- Etanercept
- First posted
- 2006-05-08
- Last updated
- 2018-06-28
- Results first posted
- 2014-03-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events | 5 years | A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time). |
| Secondary | Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | 5 years | Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure. |
| Secondary | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) | Baseline and at 3 and 5 years | The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe). |
| Secondary | Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 | Baseline and at 3 and 5 years | The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe). |
| Secondary | Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response | Baseline, Year 3 and Year 5 | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0. |
| Secondary | Euroqol-5D (EQ-5D) Total Score | Baseline, Year 3 and Year 5 | EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health. |
| Secondary | Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) | Baseline, Year 3 and Year 5 | The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today. |
| Secondary | Healthcare Resource Use | Baseline, Year 3 and Year 5 | This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported: 1. How many times have you been to any physician's office or urgent care clinic, not including your dermatologist? 2. How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor? 3. How many times have you received care from a health professional (HP) in your home? 4. How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)? 5. How many times have you had a friend or family member take time off work to provide care or transportation? |
| Secondary | Work Productivity and Activity Impairment (WPAI) | Baseline, Year 3 and Year 5 | The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes). |
| Secondary | Percentage of Body Surface Area Affected by Psoriasis | Baseline, Year 3 and Year 5 | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events | 5 years | proportion of participants | NUMBER | |
| SECONDARY | Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | 5 years | Full analysis set | proportion of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) | Baseline and at 3 and 5 years | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 | Baseline and at 3 and 5 years | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response | Baseline, Year 3 and Year 5 | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | percentage of participants | NUMBER |
| SECONDARY | Euroqol-5D (EQ-5D) Total Score | Baseline, Year 3 and Year 5 | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | units on a scale | MEAN |
| SECONDARY | Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) | Baseline, Year 3 and Year 5 | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | units on a scale | MEAN |
| SECONDARY | Healthcare Resource Use | Baseline, Year 3 and Year 5 | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | times | MEAN |
| SECONDARY | Work Productivity and Activity Impairment (WPAI) | Baseline, Year 3 and Year 5 | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n), and who were employed (for the first 3 scores). | units on a scale | MEAN |
| SECONDARY | Percentage of Body Surface Area Affected by Psoriasis | Baseline, Year 3 and Year 5 | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | percentage of body surface area | MEAN |
Source ClinicalTrials.gov
Results by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events | Etanercept | Serious Adverse Events | 0.2029 | 95% Confidence Interval 0.1799 to 0.2260 | proportion of participants |
| Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events | Etanercept | Serious Infectious Events | 0.0581 | 95% Confidence Interval 0.0447 to 0.0716 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | Malignancy, including BCC, SCC and lymphoma | 0.0659 | 95% Confidence Interval 0.0538 to 0.0780 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | Coronary artery disease | 0.0283 | 95% Confidence Interval 0.0202 to 0.0364 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | Worsening of psoriasis | 0.0074 | 95% Confidence Interval 0.0032 to 0.0115 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | CNS demyelinating disorder | 0.0018 | 95% Confidence Interval -0.0002 to 0.0039 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | Tuberculosis | 0.0013 | 95% Confidence Interval -0.0005 to 0.0030 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | Lupus disease | 0.0006 | 95% Confidence Interval -0.0006 to 0.0018 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | Opportunistic infection | 0.0006 | 95% Confidence Interval -0.0006 to 0.0018 | proportion of participants |
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Etanercept | Coccidioidomycosis | NA | 95% Confidence Interval NA to NA | proportion of participants |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etanercept | 2,511 | |
| Overall Study | Received at Least 1 Dose of Etanercept | Etanercept | 2,510 | |
| Overall Study | COMPLETED | Etanercept | 1,455 | |
| Overall Study | NOT COMPLETED | Etanercept | 1,056 |
Source ClinicalTrials.gov
Adverse events366
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Etanercept | 3 | 2,510 | |
| serious | Haemorrhagic Anaemia | Blood and lymphatic system disorders | Etanercept | 1 | 2,510 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Etanercept | 2 | 2,510 | |
| serious | Leukopenia | Blood and lymphatic system disorders | Etanercept | 1 | 2,510 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Etanercept | 2 | 2,510 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Etanercept | 1 | 2,510 | |
| serious | Acute Coronary Syndrome | Cardiac disorders | Etanercept | 3 | 2,510 | |
| serious | Acute Myocardial Infarction | Cardiac disorders | Etanercept | 3 | 2,510 | |
| serious | Angina Pectoris | Cardiac disorders | Etanercept | 8 | 2,510 | |
| serious | Angina Unstable | Cardiac disorders | Etanercept | 1 | 2,510 |
1 to 10 of 366Source ClinicalTrials.gov
See all 366 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | ||
| Total, other adverse events | Etanercept | 0 | 2,510 |
| Total, serious adverse events | Etanercept | 418 | 2,510 |
Source ClinicalTrials.gov
Papers3
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/NCT00322439
GET https://conductscience.org/api/trials/v1/NCT00322439/results?page=2