Clinical trial NCT04507776: Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel
Official title: Long Term Adherence and Efficacy of Etanercept in SpA Iraqi Patients: 7 Year Data From Local Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthrosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 763
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients data from the local Baghdad Teaching Hospital (Rheumatology Center) registry

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With 7 Years Adherence to Etanercept
timeFrame: 7 years [from the data retrieved and observed in 1 month of this study]
Secondary outcomes:
Other outcomes:
measure: Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
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]
measure: Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
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]
measure: Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
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]
measure: Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
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]
Locations:
city: Baghdad
country: Iraq
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Younis AA, Al-Hafidh AH, Adnan A, Yasiry D, Abdulateef N, Gorial FI, Llamado L, AlJabban A. Long-Term Adherence to Etanercept in Treatment Effectiveness of Patients with Spondyloarthritis: 7-Year Data from the Iraq National Registry. Rheumatol Ther. 2022 Dec;9(6):1605-1616. doi: 10.1007/s40744-022-00497-y. Epub 2022 Sep 30.