Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04507776
• Collaborator: (none)
• Enrollment: 763
• Location: 1
• Actual Duration (Days): 30
• Patients Per Site Per Month: 774.1

Study Details

Study Description

Brief Summary

This study is to evaluate local data in Iraqi patients with Spondyloarthropathies on Enbrel treatment with regards to efficacy and adherence using data from the Baghdad Teaching Hospital (Rheumatology Center)

Condition or Disease	Intervention/Treatment	Phase
Spondyloarthrosis	Drug: Etanercept

Study Design

• Study Type: Observational
• Actual Enrollment: 763 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Long Term Adherence and Efficacy of Etanercept in SpA Iraqi Patients: 7 Year Data From Local Registry
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients with spondyloarthropathies Patients with spondyloarthrosis that received Etanercept as treatment for disease	Drug: Etanercept; Patients with spondyloarthrosis as provided in real world practice; Other Names: Enbrel

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With 7 Years Adherence to Etanercept [7 years [from the data retrieved and observed in 1 month of this study]]

   In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported.

Other Outcome Measures

1. 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 (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]]

   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.

2. Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment [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]]

   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.

3. Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment [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]]

   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.

4. Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment [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]]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed SpA patients

• 18 years of age and older.

• Did not receive previous other biological treatments.

• Patients have at least 1 year on Enbrel.

Exclusion Criteria:

• Had previously used another biological treatments.

• Use of etanercept for less than 1 year duration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer	Baghdad		Iraq

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 28, 2021

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04507776
• Other Study ID Numbers: B1801414
• First Posted: Aug 11, 2020
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Spondylarthropathies; Etanercept

Study Results

Participant Flow

Pre-assignment Detail

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.

Arm/Group Title	Etanercept
Arm/Group Description	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.
Period Title: Overall Study
STARTED	763
COMPLETED	562
NOT COMPLETED	201

Baseline Characteristics

Arm/Group Title	Etanercept
Arm/Group Description	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 Participants	763
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	36.3 (10.5)
Sex: Female, Male (Count of Participants)
Female	136 17.8%
Male	627 82.2%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With 7 Years Adherence to Etanercept
Description	In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported.
Time Frame	7 years [from the data retrieved and observed in 1 month of this study]

Outcome Measure Data

Analysis Population Description

Analysis population included all participants whose data were included in the study for retrospective observation.

Arm/Group Title	Etanercept
Arm/Group Description	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.
Measure Participants	763
Number [Percentage of participants]	60.6 7.9%

2. Other Pre-specified Outcome

Title	Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Description	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.
Time Frame	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]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Etanercept: Participants Adherent to Treatment	Etanercept: Participants Not Adherent to Treatment
Arm/Group Description	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 adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.	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.
Measure Participants	700	63
Year 1 Adherence: Baseline	8.0579 (0.83161)	8.0238 (0.81532)
Year 1 Adherence: Year 1 (Month 12)	1.3310 (1.74750)	3.8261 (1.71364)
Year 7 Adherence: Baseline	8.4813 (0.51830)	8.0000 (0.88561)
Year 7 Adherence: Year 7	1.3256 (1.49022)	1.1040 (1.68353)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 1 Adherence: Baseline
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.75
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 1 Adherence: Year 1 (Month 12)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 7 Adherence: Baseline
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 7 Adherence: Year 7
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	t-test, 2 sided
	Comments

3. Other Pre-specified Outcome

Title	Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
Description	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.
Time Frame	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]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Etanercept: Participants Adherent to Treatment	Etanercept: Participants Not Adherent to Treatment
Arm/Group Description	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.	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.
Measure Participants	700	63
Year 1 Adherence: Change at Year 1 (Month 12)	6.7269 (1.90446)	4.1977 (1.84639)
Year 7 Adherence: Change at Year 7	6.8344 (1.86489)	6.4096 (2.30636)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 1 Adherence: Change at Year 1 (Month 12)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 7 Adherence: Change at Year 7
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.247
	Comments
	Method	t-test, 2 sided
	Comments

4. Other Pre-specified Outcome

Title	Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
Description	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.
Time Frame	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]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Etanercept: Participants Adherent to Treatment	Etanercept: Participants Not Adherent to Treatment
Arm/Group Description	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 adherent to treatment. Data of these participants were studied for 1 month in this retrospective, observational study.	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
Measure Participants	700	63
Year 1 Adherence: Baseline	7.7324 (1.13568)	7.9143 (0.93668)
Year 1 Adherence: Year 1 (Month 12)	1.3028 (1.69316)	3.7372 (1.71182)
Year 7 Adherence: Baseline	6.6812 (1.60341)	7.8058 (0.98626)
Year 7 Adherence: Year 7	1.3256 (1.49022)	0.9720 (1.39840)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 1 Adherence: Baseline
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 1 Adherence: Year 1 (Month 12)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 7 Adherence: Baseline
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.62
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 7 Adherence: Year 7
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	t-test, 2 sided
	Comments

5. Other Pre-specified Outcome

Title	Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
Description	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.
Time Frame	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]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Etanercept	Etanercept: Participants Not Adherent to Treatment
Arm/Group Description	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.	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
Measure Participants	700	63
Year 1 Adherence: Change at Year 1 (Month 12)	6.4296 (2.03555)	4.1771 (1.88158)
Year 7 Adherence: Change at Year 7	5.1206 (2.38577)	6.3327 (1.94510)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 1 Adherence: Change at Year 1 (Month 12)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept, Etanercept: Participants Not Adherent to Treatment
	Comments	Year 7 Adherence: Change at Year 7
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Not applicable as adverse events not collected during the study
Adverse Event Reporting Description	Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not meet, hence adverse events were not collected and reported.
Arm/Group Title	Etanercept
Arm/Group Description	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.
All Cause Mortality
	Etanercept
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.