Trial Outcomes & Findings for Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis (NCT NCT04507763)
NCT ID: NCT04507763
Last Updated: 2021-10-28
Results Overview
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.
COMPLETED
763 participants
Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
2021-10-28
Participant Flow
Data of Iraq's participants aged greater than or equal to (\>=) 18 years, who received etanercept for at least 1 year anytime from August 2012 through March 2020 for treatment of ankylosing spondylitis (AS) and met American College of Rheumatology/ European League Against Rheumatism (EULAR) 2019 criteria for AS were included in the study. Data were collected from dermatology center of Baghdad teaching hospital. Available data were evaluated in 2 months of this retrospective, observational study.
Participant milestones
| Measure |
Etanercept
Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 milligrams \[mg\] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study.
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|---|---|
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Overall Study
STARTED
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763
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Overall Study
COMPLETED
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562
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Overall Study
NOT COMPLETED
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201
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Reasons for withdrawal
| Measure |
Etanercept
Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 milligrams \[mg\] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study.
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|---|---|
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Overall Study
Participants did not meet entrance criteria
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201
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Etanercept
n=763 Participants
Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study.
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|---|---|
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Age, Continuous
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36.3 Years
STANDARD_DEVIATION 10.5 • n=763 Participants
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Sex: Female, Male
Female
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136 Participants
n=763 Participants
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Sex: Female, Male
Male
|
627 Participants
n=763 Participants
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Education Level
Primary education
|
319 Participants
n=763 Participants
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|
Education Level
Secondary education
|
231 Participants
n=763 Participants
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Education Level
Higher education
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213 Participants
n=763 Participants
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Smoking Status
Yes
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389 Participants
n=763 Participants
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Smoking Status
No
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374 Participants
n=763 Participants
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Disease Duration
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5.9 Years
STANDARD_DEVIATION 6.1 • n=763 Participants
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Current Steroid Therapy
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614 Participants
n=763 Participants • In this baseline measure, number of participants who were on steroid therapy were reported.
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
8.1 Units on a scale
STANDARD_DEVIATION 0.8 • n=763 Participants
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Bath Ankylosing Spondylitis Functional Index (BASFI)
|
7.7 Units on a scale
STANDARD_DEVIATION 1.1 • n=763 Participants
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Human Leukocyte Antigen B27 (HLA-B27)
Positive
|
242 Participants
n=763 Participants
|
|
Human Leukocyte Antigen B27 (HLA-B27)
Negative
|
167 Participants
n=763 Participants
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|
Human Leukocyte Antigen B27 (HLA-B27)
Not done
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354 Participants
n=763 Participants
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PRIMARY outcome
Timeframe: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]Population: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Early Referral (<=1 Year)
n=239 Participants
Participants who were referred early (\<=1 year after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
|
Etanercept: Participants With Delayed Referral (1.1 to 5 Years)
n=209 Participants
Participants who were referred delayed (1.1 to 5 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
|
Etanercept: Participants With Delayed Referral (5.1 to 10 Years)
n=138 Participants
Participants who were referred delayed (5.1 to 10 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
|
Etanercept: Participants With Delayed Referral (>10 Years)
n=177 Participants
Participants who were referred delayed (\>10 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).. Data of these participants were studied for 2 months in this retrospective, observational study.
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|---|---|---|---|---|
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Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
Baseline
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7.75 Units on a scale
Standard Deviation 1.11
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7.74 Units on a scale
Standard Deviation 1.11
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7.72 Units on a scale
Standard Deviation 1.15
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7.78 Units on a scale
Standard Deviation 1.13
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Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
Change from baseline at month 12
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-6.21 Units on a scale
Standard Deviation 1.557
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-5.44 Units on a scale
Standard Deviation 1.510
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-4.14 Units on a scale
Standard Deviation 1.697
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-4.04 Units on a scale
Standard Deviation 1.631
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PRIMARY outcome
Timeframe: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]Population: 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.
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.
Outcome measures
| Measure |
Etanercept: Participants With Early Referral (<=1 Year)
n=239 Participants
Participants who were referred early (\<=1 year after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
|
Etanercept: Participants With Delayed Referral (1.1 to 5 Years)
n=209 Participants
Participants who were referred delayed (1.1 to 5 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
|
Etanercept: Participants With Delayed Referral (5.1 to 10 Years)
n=138 Participants
Participants who were referred delayed (5.1 to 10 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for 2 months in this retrospective, observational study.
|
Etanercept: Participants With Delayed Referral (>10 Years)
n=177 Participants
Participants who were referred delayed (\>10 years after diagnosis with AS) for management of AS with etanercept treatment and received etanercept for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).. Data of these participants were studied for 2 months in this retrospective, observational study.
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|---|---|---|---|---|
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Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12
Baseline
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8.32 Units on a scale
Standard Deviation 0.88
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8.36 Units on a scale
Standard Deviation 0.47
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8.46 Units on a scale
Standard Deviation 0.72
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8.22 Units on a scale
Standard Deviation 0.86
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Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12
Change from baseline at month 12
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-6.86 Units on a scale
Standard Deviation 1.550
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-6.05 Units on a scale
Standard Deviation 1.549
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-4.82 Units on a scale
Standard Deviation 1.782
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-4.4 Units on a scale
Standard Deviation 1.728
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Adverse Events
Etanercept
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER