Trial · NCT00247962

Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

NCT00247962, Phase 4, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2012-11-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis. Trials, record NCT00247962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00247962

On this page

Trial

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

Title: Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
NCT number: NCT00247962
Status: Completed
Phases: Phase 4
Enrollment: 566 participants, actual
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Conditions: Ankylosing Spondylitis
Interventions: etanercept, sulphasalazine (SSZ)
First posted: 2005-11-02
Last updated: 2012-11-08
Results first posted: 2012-11-08

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 Assessment in Ankylosing Spondylitis (ASAS 20)	16 weeks	ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Secondary	Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	Baseline and 16 Weeks	ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a "Yes" (scored as 1) or "No" (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)	16 weeks	All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations.	participants	NUMBER
SECONDARY	Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	Baseline and 16 Weeks	The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.	units on a scale	MEAN

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	Spread	Units
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)	Etanercept		287		participants
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)	Sulphasalazine		99		participants
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	Etanercept	Baseline	11.03	Standard Deviation 4.60	units on a scale
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	Sulphasalazine	Baseline	11.32	Standard Deviation 4.75	units on a scale
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	Etanercept	Week 16	6.21	Standard Deviation 5.31	units on a scale
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline	Sulphasalazine	Week 16	9.06	Standard Deviation 5.68	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Etanercept	379
Overall Study	STARTED	Sulphasalazine	187
Overall Study	COMPLETED	Etanercept	353
Overall Study	COMPLETED	Sulphasalazine	168
Overall Study	NOT COMPLETED	Etanercept	26
Overall Study	NOT COMPLETED	Sulphasalazine	19

Source ClinicalTrials.gov

Adverse events46

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	29	379
other	Headache	General disorders	Sulphasalazine	21	187
other	Injection Site Reaction	General disorders	Etanercept	41	379
other	Injection Site Reaction	General disorders	Sulphasalazine	3	187
other	Cardiovascular	Vascular disorders	Etanercept	23	379
other	Cardiovascular	Vascular disorders	Sulphasalazine	10	187
other	Nausea	Gastrointestinal disorders	Etanercept	25	379
other	Nausea	Gastrointestinal disorders	Sulphasalazine	18	187
other	Metabolic and Nutritional	Metabolism and nutrition disorders	Etanercept	24	379
other	Metabolic and Nutritional	Metabolism and nutrition disorders	Sulphasalazine	5	187

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Etanercept
Total, all-cause mortality	Sulphasalazine
Total, other adverse events	Etanercept	213
Total, other adverse events	Sulphasalazine	100
Total, serious adverse events	Etanercept	7
Total, serious adverse events	Sulphasalazine	4

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21630245	DERIVED	PubMed
22337244	DERIVED	PubMed
30473179	DERIVED	PubMed
38488976	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 vs Sulphasalazine: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)

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/NCT00247962

GET https://conductscience.org/api/trials/v1/NCT00247962/events?page=2

API reference For AI assistants