Trial · NCT00357903

Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

NCT00357903, Phase 3, Completed, Amgen; results first posted 2010-12-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials. Trials, record NCT00357903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00357903

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Trial

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

Title: Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials
NCT number: NCT00357903
Status: Completed
Phases: Phase 3
Enrollment: 639 participants, actual
Lead sponsor: Amgen
Conditions: Rheumatoid Arthritis
Interventions: Etanercept
First posted: 2006-07-28
Last updated: 2017-02-09
Results first posted: 2010-12-06

Source ClinicalTrials.gov

Registered outcomes19

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

List	Outcome	Time frame	Description
Primary	Total Exposure to Etanercept With Gaps	Up to 10 years	Total participant exposure to etanercept (Enbrel) with gaps
Primary	Total Exposure Adjusted Rate of Malignancies	Up to 10 years	Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Primary	Total Exposure Adjusted Rate of Deaths	Up to 10 years	Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Primary	Total Exposure Adjusted Rate of Serious Infectious Events	Up to 10 years	Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
Primary	Total Exposure Adjusted Rate of Lymphomas	Up to 10 years	Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Primary	Malignancy	Up to 10 years	Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept
Primary	Lymphoma	Up to 10 years	Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Primary	Serious Infectious Event	Up to 10 years	Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.
Primary	Death	Up to 10 years	Occurrence of death on study within 30 days of the last dose of etanercept
Primary	Total Exposure Adjusted Rate of Serious Adverse Events	Up to 10 years	Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Exposure to Etanercept With Gaps	Up to 10 years	All participants who received at least one dose of etanercept	Participant-years	NUMBER
SECONDARY	Dosing Period	Up to 10 years	All participants who received at least one dose of etanercept	Days	MEAN
PRIMARY	Total Exposure Adjusted Rate of Malignancies	Up to 10 years	All participants who received at least one dose of etanercept	Malignancies per 100 participant-years	NUMBER
PRIMARY	Total Exposure Adjusted Rate of Deaths	Up to 10 years	All participants who received at least one dose of etanercept	Deaths per 100 participant-years	NUMBER
PRIMARY	Total Exposure Adjusted Rate of Serious Infectious Events	Up to 10 years	All participants who received at least one dose of etanercept	Events per 100 participant-years	NUMBER
PRIMARY	Total Exposure Adjusted Rate of Lymphomas	Up to 10 years	All participants who received at least one dose of etanercept	Lymphomas per 100 participant-years	NUMBER
PRIMARY	Malignancy	Up to 10 years	All participants who received at least one dose of etanercept	Participants	NUMBER
PRIMARY	Lymphoma	Up to 10 years	All participants who received at least one dose of etanercept	Participants	NUMBER
PRIMARY	Serious Infectious Event	Up to 10 years	All participants who received at least one dose of etanercept	Participants	NUMBER
PRIMARY	Death	Up to 10 years	All participants who received at least one dose of etanercept	Participants	NUMBER

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group34

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

Outcome	Group	Value	Spread	Units
Total Exposure to Etanercept With Gaps	Adult Participants	4033.07		Participant-years
Total Exposure to Etanercept With Gaps	Pediatric Participants	341.98		Participant-years
Dosing Period	Adult Participants	2535.4	Standard Deviation 1433.77	Days
Dosing Period	Pediatric Participants	2153.6	Standard Deviation 1379.15	Days
Total Exposure Adjusted Rate of Malignancies	Adult Participants	1.41		Malignancies per 100 participant-years
Total Exposure Adjusted Rate of Malignancies	Pediatric Participants	0.00		Malignancies per 100 participant-years
Total Exposure Adjusted Rate of Deaths	Adult Participants	0.57		Deaths per 100 participant-years
Total Exposure Adjusted Rate of Deaths	Pediatric Participants	0.00		Deaths per 100 participant-years
Total Exposure Adjusted Rate of Serious Infectious Events	Adult Participants	5.18		Events per 100 participant-years
Total Exposure Adjusted Rate of Serious Infectious Events	Pediatric Participants	3.22		Events per 100 participant-years

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Adult Participants	581
Overall Study	STARTED	Pediatric Participants	58
Overall Study	COMPLETED	Adult Participants	218
Overall Study	COMPLETED	Pediatric Participants	15
Overall Study	NOT COMPLETED	Adult Participants	363
Overall Study	NOT COMPLETED	Pediatric Participants	43

Source ClinicalTrials.gov

Adverse events778

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	Abdominal pain	Gastrointestinal disorders	Total Adults	25	581
other	Abdominal pain	Gastrointestinal disorders	Pediatric Subjects	5	58
other	Abdominal pain upper	Gastrointestinal disorders	Total Adults	15	581
other	Abdominal pain upper	Gastrointestinal disorders	Pediatric Subjects	7	58
other	Diarrhoea	Gastrointestinal disorders	Total Adults	52	581
other	Diarrhoea	Gastrointestinal disorders	Pediatric Subjects	4	58
other	Dyspepsia	Gastrointestinal disorders	Total Adults	37	581
other	Dyspepsia	Gastrointestinal disorders	Pediatric Subjects	4	58
other	Nausea	Gastrointestinal disorders	Total Adults	40	581
other	Nausea	Gastrointestinal disorders	Pediatric Subjects	5	58

1 to 10 of 778Source ClinicalTrials.gov

See all 778 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Total Adults
Total, all-cause mortality	Pediatric Subjects
Total, other adverse events	Total Adults	484	581
Total, other adverse events	Pediatric Subjects	49	58
Total, serious adverse events	Total Adults	293	581
Total, serious adverse events	Pediatric Subjects	16	58

Source ClinicalTrials.gov

Papers10

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11352248	BACKGROUND	PubMed
11409115	BACKGROUND	PubMed
11987981	BACKGROUND	PubMed
12528122	BACKGROUND	PubMed
12672185	BACKGROUND	PubMed
12794815	BACKGROUND	PubMed
16541481	BACKGROUND	PubMed
16732547	BACKGROUND	PubMed
18438876	BACKGROUND	PubMed
20957659	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 comparisons5

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

Comparison	Source
Adult Participants vs Pediatric Participants: Serious Infectious Event	Trial comparisons
Adult Participants vs Pediatric Participants: Lymphoma	Trial comparisons
Adult Participants vs Pediatric Participants: Death	Trial comparisons
Adult Participants vs Pediatric Participants: Malignancy	Trial comparisons
Total Adults vs Pediatric Subjects: 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.

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/NCT00357903

GET https://conductscience.org/api/trials/v1/NCT00357903/results?page=2

API reference For AI assistants