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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507763
• Other study ID #: B1801415
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Etanercept
Patients with ankylosing spondylitis as provided in real world practice

Locations

Country	Name	City	State
Iraq	Pfizer	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
Primary	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.	Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]

External Links

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