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

Spondyloarthrosis Clinical Trial

Official title:

Long Term Adherence and Efficacy of Etanercept in SpA Iraqi Patients: 7 Year Data From Local Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507776
• Other study ID #: B1801414
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthropathies
• Spondyloarthrosis

Intervention

Drug:
• Etanercept
Patients with spondyloarthrosis as provided in real world practice

Locations

Country	Name	City	State
Iraq	Pfizer	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment	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.	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]
Other	Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment	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.	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]
Other	Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment	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.	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]
Other	Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment	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.	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]
Primary	Percentage of Participants With 7 Years Adherence to Etanercept	In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported.	7 years [from the data retrieved and observed in 1 month of this study]

External Links

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