Ankylosing SpondylitisPhase 4NCT00410046

Extension Study Evaluating Etanercept in Ankylosing Spondylitis

A Phase 4 study testing Enbrel (etanercept) in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 16 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ankylosing Spondylitis
What is being tested?: Enbrel (etanercept)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 16 sitesin 4 countries
Study dates: Dec 2006to Oct 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who completed 16 weeks of treatment and have completed the baseline health care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries.

Who cannot join

Withdrawal from the ASCEND study for safety or any other reason.

Trial locations and contacts

16 sites in 4 countries.

Country

City, postcode or hospital

16 sites in 4 countries

United Kingdom7 sites

Study site
Basingstoke, RG249NA
Study site
Bath, BA11RL
Study site
Cambridge, CB22QQ
Study site
Cannock, WS112XY
Study site
Liverpool, L97AL
Study site
Metropolitan Borough of Wirral, CH495PE
Study site
Newcastle upon Tyne, NE77DN

Other trials in United Kingdom

Denmark4 sites

Study site
Fredriksberg, DK-2000
Study site
Odense, DK-5000
Study site
Svendborg, DK-5700
Study site
Vejle, DK-7100

Other trials in Denmark

Finland4 sites

Study site
Helsinki, FIN-130
Study site
Hyvinkää, FIN-05800
Study site
Kuopio, FIN-70211
Study site
Tampere, FIN-33100

Other trials in Finland

Sweden1 site

Study site
Stockholm, SE-17176

Other trials in Sweden

About this study

Official title: An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis

Conditions: Ankylosing Spondylitis
Being tested: Enbrel (etanercept)
Medical subject headings: Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enbrel (etanercept)Drug
Also called Enbrel
Etanercept 50 mg SC injection once weekly

Study groups in NCT00410046
Study group	Role	What they receive
Etanercept (ETN)	Experimental	Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks. Receives: Drug: Enbrel (etanercept)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
Measured: 96 weeks
Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
Measured: 96 weeks

Secondary outcomes (12)

Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks of treatment.
Measured: 48 weeks
Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking all patients whether or not they had used the healthcare resource during the 48 weeks of treatment, and if so, how many times the resource was used. The mean number of times is based on those patients who responded to the questionnaire stating they had utilized healthcare resources (see outcome measure 3).
Measured: 48 weeks
Number of Patients With Sick Leave During 48 Weeks Treatment
The impact of treatment on work productivity was assessed by sick leave. Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days.
Measured: 48 weeks
Number of Sick Days Per Patient During the 48 Weeks of Treatment
Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days. The mean number of days is based on those patients who had sick leave during the treatment period.
Measured: 48 weeks
Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Measured: Baseline and 38 weeks
Change in Total Back Pain Score From Baseline to Week 38
Total Back Pain was measured on a 0 to 100 mm VAS, with 0 mm indicating no pain. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Measured: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38
BASFI is a validated self assessment tool that determines the degree of functional limitation in Ankylosing Spodylitis (AS) patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions, with a maximum score of 100 mm. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Measured: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Measured: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Measured: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38
BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The fatigue-specific score is presented here. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Measured: Baseline and 38 weeks
Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38
ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the patient as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). The 0881A3-402 baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Measured: Baseline and 38 weeks
Change From Baseline Haywood Quality of Life Score From Baseline to Week 38
Haywood quality of life instrument was utilized in the United Kingdom as the ASQoL measure. The ASQoL is an AS-specific measure of QoL, scores range from 0 (good QoL) to 80 (poor QoL). ASQoL is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patient's 0881A3-402 baseline score was used in the analysis. Change=baseline-week 38.
Measured: Baseline and 38 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Oct 2008

First posted12 Dec 2006 (estimated)
Study startDec 2006
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00410046
Sponsor's protocol ID: 0881A3-405
Status last verified: Apr 2012
First submitted: 8 Dec 2006
Last updated: 11 May 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.
PubMed 38488976

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
Not yet recruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 4
Ivarmacitinib With or Without Celecoxib for Ankylosing Spondylitis
Ankylosing Spondylitis (AS)
Active, not recruitingObservational study
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis

All Ankylosing Spondylitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis
ClinicalTrials.gov ID: NCT00410046
Acronym / sponsor ID: 0881A3-405
Conditions: Ankylosing Spondylitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 12 Dec 2006 (estimated)
Results: Posted 11 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Etanercept (ETN)	Experimental	Drug: Enbrel (etanercept)Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who completed 16 weeks of treatment and have completed the baseline health care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries.

Key exclusion criteria (1 listed)

Withdrawal from the ASCEND study for safety or any other reason.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enbrel (etanercept)Also: EnbrelEtanercept 50 mg SC injection once weekly	Drug	Etanercept (ETN)

Primary outcome

Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
Time frame: 96 weeks
Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
Time frame: 96 weeks
Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).

12 secondary outcomes

Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
Time frame: 48 weeks
Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
Time frame: 48 weeks
Number of Patients With Sick Leave During 48 Weeks Treatment
Time frame: 48 weeks
Number of Sick Days Per Patient During the 48 Weeks of Treatment
Time frame: 48 weeks
Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
Time frame: Baseline and 38 weeks
Change in Total Back Pain Score From Baseline to Week 38
Time frame: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38
Time frame: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
Time frame: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38
Time frame: Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38
Time frame: Baseline and 38 weeks
Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38
Time frame: Baseline and 38 weeks
Change From Baseline Haywood Quality of Life Score From Baseline to Week 38
Time frame: Baseline and 38 weeks

Results and safety

Results posted to the registry on 11 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etanercept	84	79

Primary outcome: Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment

Time frame: 96 weeks. Number. Unit: patients

Measure	Etanercept / ETN n = 59
Hospitalization 48 weeks before treatment	6
Hospitalization during 48 treatment weeks	4
Therapeutic warm bath 48 weeks before treatment	8
Therapeutic warm bath during 48 treatment weeks	4
Visit to physiotherapist 48 weeks before treatment	26
Visit to physiotherapist during 48 treatment weeks	11
Out-patient physician 48 weeks before treatment	40
Out-patient physician during 48 treatment weeks	30

Etanercept / ETN: p = 0.743, Fisher Exact
Etanercept / ETN: p = 0.362, Fisher Exact
Etanercept / ETN: p = 0.005, Fisher Exact

Population analysed: All patients who took ETN and completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.

Primary outcome: Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment

Time frame: 96 weeks. Number. Unit: patients

Measure	Etanercept / ETN n = 59
Sick leave 48 weeks before treatment	27
Sick leave during 48 weeks of treatment	23

Etanercept / ETN: p = 0.576, Fisher Exact

Population analysed: All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etanercept	5 of 84 (6%)	66 of 84 (78.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38488976Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.

Related trials for Ankylosing Spondylitis

RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
Not yet recruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 4
Ivarmacitinib With or Without Celecoxib for Ankylosing Spondylitis
Ankylosing Spondylitis (AS)
Active, not recruitingObservational study
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Wyeth Reserach

16 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enbrel (etanercept) in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 16 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom, Denmark, Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment (time frame: 96 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410046, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2012.