Trial · NCT00245960

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

NCT00245960, Phase 4, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2009-05-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis. Trials, record NCT00245960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00245960

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
NCT number: NCT00245960
Status: Completed
Phases: Phase 4
Enrollment: 752 participants, actual
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Conditions: Psoriatic Arthritis
Interventions: etanercept, etanercept, Placebo
First posted: 2005-10-28
Last updated: 2022-01-31
Other registries' IDs: eudract:2005-001533-15
Results first posted: 2009-05-27

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis	12 weeks	The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.
Secondary	Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	12 and 24 weeks	The PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	12 and 24 weeks	The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation.	participants	NUMBER
PRIMARY	Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis	12 weeks	The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation.	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	Etanercept BIW/QW	At 12 Weeks	284	participants
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	Etanercept QW/QW	At 12 Weeks	282	participants
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	Etanercept BIW/QW	At 24 Weeks	303	participants
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	Etanercept QW/QW	At 24 Weeks	299	participants
Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis	Etanercept BIW/QW		176	participants
Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis	Etanercept QW/QW		119	participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1 (Double Blind): 1-12 Weeks	STARTED	Etanercept BIW/QW	379
Period 1 (Double Blind): 1-12 Weeks	STARTED	Etanercept QW/QW	373
Period 1 (Double Blind): 1-12 Weeks	COMPLETED	Etanercept BIW/QW	364
Period 1 (Double Blind): 1-12 Weeks	COMPLETED	Etanercept QW/QW	362
Period 1 (Double Blind): 1-12 Weeks	NOT COMPLETED	Etanercept BIW/QW	15
Period 1 (Double Blind): 1-12 Weeks	NOT COMPLETED	Etanercept QW/QW	11
Period 2 (Open Label): 13-24 Weeks	STARTED	Etanercept BIW/QW	364
Period 2 (Open Label): 13-24 Weeks	STARTED	Etanercept QW/QW	362
Period 2 (Open Label): 13-24 Weeks	COMPLETED	Etanercept BIW/QW	350
Period 2 (Open Label): 13-24 Weeks	COMPLETED	Etanercept QW/QW	344

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events68

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
other	Headache	General disorders	Etanercept BIW/QW	19	379
other	Headache	General disorders	Etanercept QW/QW	19	373
other	Injection site	General disorders	Etanercept BIW/QW	32	379
other	Injection site	General disorders	Etanercept QW/QW	23	373
other	Cardiovascular general disorders	Cardiac disorders	Etanercept BIW/QW	24	379
other	Cardiovascular general disorders	Cardiac disorders	Etanercept QW/QW	23	373
other	Digestive general disorders	Gastrointestinal disorders	Etanercept BIW/QW	38	379
other	Digestive general disorders	Gastrointestinal disorders	Etanercept QW/QW	37	373
other	Metabolic and nutritional general disorders	Metabolism and nutrition disorders	Etanercept BIW/QW	23	379
other	Metabolic and nutritional general disorders	Metabolism and nutrition disorders	Etanercept QW/QW	20	373

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Etanercept BIW/QW
Total, all-cause mortality	Etanercept QW/QW
Total, other adverse events	Etanercept BIW/QW	213
Total, other adverse events	Etanercept QW/QW	190
Total, serious adverse events	Etanercept BIW/QW	15
Total, serious adverse events	Etanercept QW/QW	11

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20124563	DERIVED	PubMed
22035157	DERIVED	PubMed
24861696	DERIVED	PubMed
25535650	DERIVED	PubMed
25913550	DERIVED	PubMed
30323006	DERIVED	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Etanercept BIW/QW vs Etanercept QW/QW: Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00245960

GET https://conductscience.org/api/trials/v1/NCT00245960/events?page=2

API reference For AI assistants