Trial · NCT00544557

Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

NCT00544557, Completed, Pfizer; results first posted 2015-05-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis. Trials, record NCT00544557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00544557

On this page

Trial

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

Title: Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
NCT number: NCT00544557
Status: Completed
Enrollment: 1,715 participants, actual
Lead sponsor: Pfizer
Conditions: Ankylosing Spondylitis
Interventions: Etanercept
First posted: 2007-10-16
Last updated: 2015-05-12
Results first posted: 2015-05-12

Source ClinicalTrials.gov

Registered outcomes28

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Achieving Partial Remission at Week 26	Week 26	Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.
Primary	Percentage of Participants Achieving Partial Remission at Week 52	Week 52	Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.
Secondary	Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)	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 or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs.
Secondary	Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity	Baseline up to Week 52
Secondary	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52	Baseline, Week 52	BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem).
Secondary	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52	Baseline, Week 52	BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).
Secondary	Change From Baseline in Occiput-to-Wall Distance at Week 52	Baseline, Week 52	Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
Secondary	Change From Baseline in Lateral Lumbar Flexion at Week 52	Baseline, Week 52	Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.
Secondary	Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52	Baseline, Week 52	Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).
Secondary	Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52	Baseline, Week 52	Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).

1 to 10 of 28Source ClinicalTrials.gov

See all 28 registered outcomes

Outcomes28

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Achieving Partial Remission at Week 26	Week 26	Effectiveness population: all treated participants greater than or equal to (\>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.	percentage of participants	NUMBER
PRIMARY	Percentage of Participants Achieving Partial Remission at Week 52	Week 52	Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' signifies participants who were evaluable for this outcome measure.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)	Baseline up to Week 52	Safety population included all treated participants with available post-baseline safety data.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity	Baseline up to Week 52	Safety population included all treated participants with available post--baseline safety data.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52	Baseline, Week 52	Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.	units on a scale	MEAN
SECONDARY	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52	Baseline, Week 52	Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.	units on a scale	MEAN
SECONDARY	Change From Baseline in Occiput-to-Wall Distance at Week 52	Baseline, Week 52	Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.	centimeter (cm)	MEAN
SECONDARY	Change From Baseline in Lateral Lumbar Flexion at Week 52	Baseline, Week 52	Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.	cm	MEAN
SECONDARY	Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52	Baseline, Week 52	Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.	units on a scale	MEAN
SECONDARY	Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52	Baseline, Week 52	Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.	units on a scale	MEAN

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group151

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Achieving Partial Remission at Week 26	Etanercept		19.0	95% Confidence Interval 16.9 to 21.2	percentage of participants
Percentage of Participants Achieving Partial Remission at Week 52	Etanercept		23.0	95% Confidence Interval 20.6 to 25.6	percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)	Etanercept	SAEs	7.6	20.6 to 25.6	percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)	Etanercept	AEs	38.2		percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity	Etanercept	SAEs	NA	20.6 to 25.6	percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity	Etanercept	AEs	NA		percentage of participants
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52	Etanercept	Baseline (n=1635)	5.327	Standard Deviation 2.029	units on a scale
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52	Etanercept	Change at Week 52 (n=1128)	-2.199	Standard Deviation 2.163	units on a scale
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52	Etanercept	Baseline (n=1626)	4.9	Standard Deviation 2.4	units on a scale
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52	Etanercept	Change at Week 52 (n=1129)	-1.7	Standard Deviation 2.2	units on a scale

1 to 10 of 151Source ClinicalTrials.gov

See all 151 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Etanercept	1,685
Overall Study	COMPLETED	Etanercept	1,251
Overall Study	NOT COMPLETED	Etanercept	434

Source ClinicalTrials.gov

Adverse events555

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	Nasopharyngitis	Infections and infestations	Etanercept	59	1,685
other	Bronchitis	Infections and infestations	Etanercept	32	1,685
other	Upper respiratory tract infection	Infections and infestations	Etanercept	24	1,685
other	Infection	Infections and infestations	Etanercept	13	1,685
other	Sinusitis	Infections and infestations	Etanercept	9	1,685
other	Urinary tract infection	Infections and infestations	Etanercept	9	1,685
other	Oral herpes	Infections and infestations	Etanercept	8	1,685
other	Respiratory tract infection	Infections and infestations	Etanercept	8	1,685
other	Pharyngitis	Infections and infestations	Etanercept	7	1,685
other	Febrile infection	Infections and infestations	Etanercept	6	1,685

1 to 10 of 555Source ClinicalTrials.gov

See all 555 adverse events

Adverse 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	588	1,685
Total, serious adverse events	Etanercept	128	1,685

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29843776	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.

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/NCT00544557

GET https://conductscience.org/api/trials/v1/NCT00544557/registered?page=2

API reference For AI assistants