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

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Etanercept

• Registration Number: NCT04507763
• Lead Sponsor: Pfizer

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-27
• Study Start: 2020-08-01
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-11
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-09
• Results First Submitted: 2021-09-29
• Results First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Results First Posted: 2021-10-28
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 763

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ankylosing spondylitis	Etanercept	Iraqi patients diagnosed with ankylosing spondylitis that received Etanercept as treatment for disease

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12	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	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.

Trial Locations

Locations (1)

Pfizer; 🇮🇶 Baghdad, Iraq