Ankylosing SpondylitisNCT04507763

Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis

An observational study of Ankylosing Spondylitis, run by Pfizer at 1 site in Iraq.

Completed

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

Trial summary

This study is to evaluate available data in Iraqi patients with ankylosing spondylitis on Enbrel treatment with regards to the impact of early treatment using data from the Baghdad Teaching Hospital registry 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?: Etanercept
How many people: 763 participants
Where: 1 siteIraq
Study dates: 1 Aug 2020to 1 Oct 2020
Phase: Observational
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

Study population: Patients data from local registry at the Baghdad Teaching Hospital

Who may be able to join

Diagnosed AS patients.
18 years old
Did not receive previous biological treatment for any reason

Who cannot join

Patients previously or currently treated with other biological therapies.
Use of etanercept for less than 1 year duration.

Trial locations and contacts

1 site in 1 country.

Iraq1 site

Pfizer
Baghdad

Other trials in Iraq

About this study

Official title: Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With Etanercept

Conditions: Ankylosing Spondylitis
Being tested: 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.

EtanerceptDrug
Also called Enbrel
Patients with ankylosing spondylitis as provided in real world practice

Study groups in NCT04507763
Study group	Role	What they receive
Patients with ankylosing spondylitis		Iraqi patients diagnosed with ankylosing spondylitis that received Etanercept as treatment for disease Receives: Drug: Etanercept

What is being measured

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

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (>) 10 years after diagnosis with AS.
Measured: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12
BASDAI is a set of 6 questions to determine disease activity in participant with AS. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in <= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and >10 years after diagnosis with AS.
Measured: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]

Timeline

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

1 Aug 20201 Oct 2020

First posted11 Aug 2020
Study start1 Aug 2020
Primary completion1 Oct 2020
Study completion1 Oct 2020

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.
Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 763 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04507763
Sponsor's protocol ID: B1801415
Status last verified: Sep 2021
First submitted: 27 Jul 2020
Last updated: 28 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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

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All Ankylosing Spondylitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With Etanercept
ClinicalTrials.gov ID: NCT04507763
Acronym / sponsor ID: B1801415
Conditions: Ankylosing Spondylitis
Study type: Observational
Recruitment status: Completed
Enrolment: 763 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Aug 2020 (actual)
Primary completion: 1 Oct 2020 (actual)
Study completion: 1 Oct 2020 (actual)
First posted: 11 Aug 2020 (actual)
Results: Posted 28 Oct 2021

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with ankylosing spondylitis	–	Drug: EtanerceptIraqi patients diagnosed with ankylosing spondylitis that received Etanercept as treatment for disease

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients data from local registry at the Baghdad Teaching Hospital

Key inclusion criteria (3 listed)

Diagnosed AS patients.
Did not receive previous biological treatment for any reason

Key exclusion criteria (2 listed)

Patients previously or currently treated with other biological therapies.
Use of etanercept for less than 1 year duration.

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
EtanerceptAlso: EnbrelPatients with ankylosing spondylitis as provided in real world practice	Drug	Patients with ankylosing spondylitis

Primary outcome

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
Time frame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (>) 10 years after diagnosis with AS.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12
Time frame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
BASDAI is a set of 6 questions to determine disease activity in participant with AS. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in <= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and >10 years after diagnosis with AS.

Results and safety

Results posted to the registry on 28 Oct 2021, 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	763	562

Primary outcome: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12

Time frame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]. Mean (Standard Deviation). Unit: Units on a scale

Measure	Etanercept: Participants With Early Referral (<=1 Year) n = 239	Etanercept: Participants With Delayed Referral (1.1 to 5 Years) n = 209	Etanercept: Participants With Delayed Referral (5.1 to 10 Years) n = 138	Etanercept: Participants With Delayed Referral (>10 Years) n = 177
Baseline	7.75 (1.11)	7.74 (1.11)	7.72 (1.15)	7.78 (1.13)
Change from baseline at month 12	-6.21 (1.557)	-5.44 (1.510)	-4.14 (1.697)	-4.04 (1.631)

Etanercept: Participants With Early Referral (<=1 Year): p = 0.001, Regression, Logistic

Population analysed: Analysis population included all participants whose data were included in the study for retrospective observation. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment.

Primary outcome: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12

Time frame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]. Mean (Standard Deviation). Unit: Units on a scale

Measure	Etanercept: Participants With Early Referral (<=1 Year) n = 239	Etanercept: Participants With Delayed Referral (1.1 to 5 Years) n = 209	Etanercept: Participants With Delayed Referral (5.1 to 10 Years) n = 138	Etanercept: Participants With Delayed Referral (>10 Years) n = 177
Baseline	8.32 (0.88)	8.36 (0.47)	8.46 (0.72)	8.22 (0.86)
Change from baseline at month 12	-6.86 (1.550)	-6.05 (1.549)	-4.82 (1.782)	-4.4 (1.728)

Etanercept: Participants With Early Referral (<=1 Year): p = 0.001, Regression, Logistic

Adverse events

Time frame: Not applicable as adverse events were not collected for the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etanercept	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by Pfizer at 1 site in Iraq.

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 3 inclusion and 2 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2021). 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?

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 (time frame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]). 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 NCT04507763.

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 28 Oct 2021.