18 and older, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12Primary· 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
Baseline
Group
Value
95% CI
Etanercept: Participants With Early Referral (<=1 Year)
7.75
± 1.11
Etanercept: Participants With Delayed Referral (1.1 to 5 Years)
7.74
± 1.11
Etanercept: Participants With Delayed Referral (5.1 to 10 Years)
7.72
± 1.15
Etanercept: Participants With Delayed Referral (>10 Years)
7.78
± 1.13
Change from baseline at month 12
Group
Value
95% CI
Etanercept: Participants With Early Referral (<=1 Year)
-6.21
± 1.557
Etanercept: Participants With Delayed Referral (1.1 to 5 Years)
-5.44
± 1.510
Etanercept: Participants With Delayed Referral (5.1 to 10 Years)
-4.14
± 1.697
Etanercept: Participants With Delayed Referral (>10 Years)
-4.04
± 1.631
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12Primary· 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 eta
Baseline
Group
Value
95% CI
Etanercept: Participants With Early Referral (<=1 Year)
8.32
± 0.88
Etanercept: Participants With Delayed Referral (1.1 to 5 Years)
8.36
± 0.47
Etanercept: Participants With Delayed Referral (5.1 to 10 Years)
8.46
± 0.72
Etanercept: Participants With Delayed Referral (>10 Years)
8.22
± 0.86
Change from baseline at month 12
Group
Value
95% CI
Etanercept: Participants With Early Referral (<=1 Year)
-6.86
± 1.550
Etanercept: Participants With Delayed Referral (1.1 to 5 Years)
-6.05
± 1.549
Etanercept: Participants With Delayed Referral (5.1 to 10 Years)
-4.82
± 1.782
Etanercept: Participants With Delayed Referral (>10 Years)
-4.4
± 1.728
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 28 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04507763.