Trial · NCT00293722
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists
NCT00293722, Completed, Pfizer; results first posted 2014-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists. Trials, record NCT00293722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00293722
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists
- NCT number
- NCT00293722
- Status
- Completed
- Enrollment
- 1,308 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis, Psoriatic, Psoriasis, Skin Diseases, Papulosquamous
- Interventions
- Etanercept
- First posted
- 2006-02-17
- Last updated
- 2014-02-26
- Results first posted
- 2014-02-26
- Limitations and caveats
- Results for Psoriasis Area and Severity Index (PASI) was not reported since it was not to be analyzed by rheumatologists as part of this study, as per planned analysis.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Week 52 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. |
| Secondary | Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Baseline, Week 52 | |
| Secondary | Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | Baseline, Week 52 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=\<) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate disease activity and \>5.1 = high disease activity. |
| Secondary | Change From Baseline in Ritchie Index at Week 52 | Baseline, Week 52 | Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness. |
| Secondary | Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Baseline, Week 52 | Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity. |
| Secondary | Number of Participants With Nail Involvement | Baseline, Week 12, 52 | Number of participants with psoriatic arthritis affecting the nails are reported. |
| Secondary | Change From Baseline in C-reactive Protein (CRP) at Week 52 | Baseline, Week 52 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Secondary | Change From Baseline in Patient Assessment of Itching at Week 52 | Baseline, Week 52 | Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale. |
| Secondary | Change From Baseline in Patient Assessment of Pain at Week 52 | Baseline, Week 52 | Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale. |
| Secondary | Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | Baseline, Week 52 | SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Week 52 | Safety analysis set included all participants who were enrolled in this study and had safety data available. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were greater than (\>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | percentage of BSA | MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Ritchie Index at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | millimeter | MEAN |
| SECONDARY | Number of Participants With Nail Involvement | Baseline, Week 12, 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | participants | NUMBER |
| SECONDARY | Change From Baseline in C-reactive Protein (CRP) at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | milligram per deciliter (mg/dL) | MEAN |
| SECONDARY | Change From Baseline in Patient Assessment of Itching at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Assessment of Pain at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | Baseline, Week 52 | Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group25
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 Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Psoriatic Arthritis | AEs | 38.1 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Psoriatic Arthritis | SAEs | 6.0 | percentage of participants | |
| Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Participants With Psoriatic Arthritis | Baseline (n=1227) | 9.7 | Standard Deviation 15.9 | percentage of BSA |
| Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Participants With Psoriatic Arthritis | Change at Week 52 (n=796) | -6.6 | Standard Deviation 13.4 | percentage of BSA |
| Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | Participants With Psoriatic Arthritis | Baseline (n=1093) | 4.8 | Standard Deviation 1.4 | units on a scale |
| Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | Participants With Psoriatic Arthritis | Change at Week 52 (n=629) | -2.2 | Standard Deviation 1.5 | units on a scale |
| Change From Baseline in Ritchie Index at Week 52 | Participants With Psoriatic Arthritis | Baseline (n=1267) | 9.9 | Standard Deviation 9.8 | units on a scale |
| Change From Baseline in Ritchie Index at Week 52 | Participants With Psoriatic Arthritis | Change at Week 52 (n=851) | -4.1 | Standard Deviation 11.9 | units on a scale |
| Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Participants With Psoriatic Arthritis | Baseline (n=1278) | 60.8 | Standard Deviation 18.8 | millimeter |
| Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Participants With Psoriatic Arthritis | Change at Week 52 (n=851) | -39.8 | Standard Deviation 24.2 | millimeter |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Psoriatic Arthritis | 1,291 | |
| Overall Study | COMPLETED | Participants With Psoriatic Arthritis | 864 | |
| Overall Study | NOT COMPLETED | Participants With Psoriatic Arthritis | 427 |
Source ClinicalTrials.gov
Adverse events425
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 | Leukopenia | Blood and lymphatic system disorders | Participants With Psoriatic Arthritis | 5 | 1,285 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Participants With Psoriatic Arthritis | 7 | 1,285 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Participants With Psoriatic Arthritis | 2 | 1,285 | |
| other | Angina pectoris | Cardiac disorders | Participants With Psoriatic Arthritis | 2 | 1,285 | |
| other | Arrhythmia | Cardiac disorders | Participants With Psoriatic Arthritis | 1 | 1,285 | |
| other | Cardiac discomfort | Cardiac disorders | Participants With Psoriatic Arthritis | 2 | 1,285 | |
| other | Cardiovascular disorder | Cardiac disorders | Participants With Psoriatic Arthritis | 1 | 1,285 | |
| other | Cyanosis | Cardiac disorders | Participants With Psoriatic Arthritis | 1 | 1,285 | |
| other | Palpitations | Cardiac disorders | Participants With Psoriatic Arthritis | 3 | 1,285 | |
| other | Tachycardia | Cardiac disorders | Participants With Psoriatic Arthritis | 1 | 1,285 |
1 to 10 of 425Source ClinicalTrials.gov
See all 425 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Psoriatic Arthritis | ||
| Total, other adverse events | Participants With Psoriatic Arthritis | 453 | 1,285 |
| Total, serious adverse events | Participants With Psoriatic Arthritis | 77 | 1,285 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29606665 | DERIVED |
Source PubMed
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/NCT00293722
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