Trial Outcomes & Findings for Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel (NCT NCT04507776)
NCT ID: NCT04507776
Last Updated: 2021-10-04
Results Overview
In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported.
COMPLETED
763 participants
7 years [from the data retrieved and observed in 1 month of this study]
2021-10-04
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 May 2012 through August 2019, for treatment of spondyloarthropathies (SpA) and met American College of Rheumatology/ European League Against Rheumatism (EULAR) 2019 criteria for SpA were included in the study. Data were collected from dermatology center of Baghdad teaching hospital. Available data were evaluated in 1 month of this retrospective, observational study.
Participant milestones
| Measure |
Etanercept
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|
|
Overall Study
STARTED
|
763
|
|
Overall Study
COMPLETED
|
562
|
|
Overall Study
NOT COMPLETED
|
201
|
Reasons for withdrawal
| Measure |
Etanercept
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|
|
Overall Study
Participants did not meet the entrance criteria
|
201
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Etanercept
n=763 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|
|
Age, Continuous
|
36.3 Years
STANDARD_DEVIATION 10.5 • n=763 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=763 Participants
|
|
Sex: Female, Male
Male
|
627 Participants
n=763 Participants
|
PRIMARY outcome
Timeframe: 7 years [from the data retrieved and observed in 1 month of this study]Population: Analysis population included all participants whose data were included in the study for retrospective observation.
In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported.
Outcome measures
| Measure |
Etanercept
n=763 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
Etanercept: Participants Not Adherent to Treatment
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were not adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|---|
|
Percentage of Participants With 7 Years Adherence to Etanercept
|
60.6 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points.
BASDAI is a set of 6 questions to determine disease activity in participant with SpA. 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. This outcome measure compared absolute BASDAI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.
Outcome measures
| Measure |
Etanercept
n=700 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
Etanercept: Participants Not Adherent to Treatment
n=63 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were not adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|---|
|
Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 1 Adherence: Baseline
|
8.0579 Units on a scale
Standard Deviation 0.83161
|
8.0238 Units on a scale
Standard Deviation 0.81532
|
|
Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 1 Adherence: Year 1 (Month 12)
|
1.3310 Units on a scale
Standard Deviation 1.74750
|
3.8261 Units on a scale
Standard Deviation 1.71364
|
|
Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 7 Adherence: Baseline
|
8.4813 Units on a scale
Standard Deviation 0.51830
|
8.0000 Units on a scale
Standard Deviation 0.88561
|
|
Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 7 Adherence: Year 7
|
1.3256 Units on a scale
Standard Deviation 1.49022
|
1.1040 Units on a scale
Standard Deviation 1.68353
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points.
BASDAI is a set of 6 questions to determine disease activity in participant with SpA. 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. This outcome measure compared change from baseline in BASDAI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.
Outcome measures
| Measure |
Etanercept
n=700 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
Etanercept: Participants Not Adherent to Treatment
n=63 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were not adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|---|
|
Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
Year 1 Adherence: Change at Year 1 (Month 12)
|
6.7269 Units on a scale
Standard Deviation 1.90446
|
4.1977 Units on a scale
Standard Deviation 1.84639
|
|
Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
Year 7 Adherence: Change at Year 7
|
6.8344 Units on a scale
Standard Deviation 1.86489
|
6.4096 Units on a scale
Standard Deviation 2.30636
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points.
BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared absolute BASFI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence, last visit was Year 7.
Outcome measures
| Measure |
Etanercept
n=700 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
Etanercept: Participants Not Adherent to Treatment
n=63 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were not adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|---|
|
Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 1 Adherence: Baseline
|
7.7324 Units on a scale
Standard Deviation 1.13568
|
7.9143 Units on a scale
Standard Deviation 0.93668
|
|
Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 1 Adherence: Year 1 (Month 12)
|
1.3028 Units on a scale
Standard Deviation 1.69316
|
3.7372 Units on a scale
Standard Deviation 1.71182
|
|
Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 7 Adherence: Baseline
|
6.6812 Units on a scale
Standard Deviation 1.60341
|
7.8058 Units on a scale
Standard Deviation 0.98626
|
|
Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Year 7 Adherence: Year 7
|
1.3256 Units on a scale
Standard Deviation 1.49022
|
0.9720 Units on a scale
Standard Deviation 1.39840
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points.
BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared change from baseline in BASFI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.
Outcome measures
| Measure |
Etanercept
n=700 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study.
|
Etanercept: Participants Not Adherent to Treatment
n=63 Participants
Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice and were not adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.
|
|---|---|---|
|
Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
Year 1 Adherence: Change at Year 1 (Month 12)
|
6.4296 Units on a scale
Standard Deviation 2.03555
|
4.1771 Units on a scale
Standard Deviation 1.88158
|
|
Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
Year 7 Adherence: Change at Year 7
|
5.1206 Units on a scale
Standard Deviation 2.38577
|
6.3327 Units on a scale
Standard Deviation 1.94510
|
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