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

NCT04507776 | Completed Results

• 1 other identifier: B1801414
• Study Type: observational
• Target: 763
• Locations: 1 country
• Sites: 1

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)

Conditions

Spondyloarthrosis

Outcome Measures

Primary Outcomes (1)

• 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]

Other Outcomes (4)

• 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]

• 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]

• 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]

Study Arms (1)

Patients with spondyloarthropathies

Patients with spondyloarthrosis that received Etanercept as treatment for disease

Drug: Etanercept

Interventions

Etanercept DRUG

Patients with spondyloarthrosis as provided in real world practice

Also known as: Enbrel

Patients with spondyloarthropathies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients data from the local Baghdad Teaching Hospital (Rheumatology Center) registry

You may qualify if:

• Diagnosed SpA patients
• years of age and older.
• Did not receive previous other biological treatments.
• Patients have at least 1 year on Enbrel.

You may not qualify if:

• Had previously used another biological treatments.
• Use of etanercept for less than 1 year duration.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Baghdad, Iraq

Location

Related Publications (1)

• 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.

  PMID: 36178583 DERIVED

Related Links

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

MeSH Terms

Conditions

Spondylarthritis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 4, 2021
• Results First Posted: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)