Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis

NCT04507763 | Completed Results

• 1 other identifier: B1801415
• Study Type: observational
• Target: 763
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate available data in Iraqi patients with ankylosing spondylitis on Enbrel treatment with regards to the impact of early treatment using data from the Baghdad Teaching Hospital registry

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12

  BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (\<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (\>) 10 years after diagnosis with AS.

  Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12

  BASDAI is a set of 6 questions to determine disease activity in participant with AS. 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. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in \<= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and \>10 years after diagnosis with AS.

  Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]

Study Arms (1)

Patients with ankylosing spondylitis

Iraqi patients diagnosed with ankylosing spondylitis that received Etanercept as treatment for disease

Drug: Etanercept

Interventions

Etanercept DRUG

Patients with ankylosing spondylitis as provided in real world practice

Also known as: Enbrel

Patients with ankylosing spondylitis

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 local registry at the Baghdad Teaching Hospital

You may qualify if:

• Diagnosed AS patients.
• years old
• Did not receive previous biological treatment for any reason

You may not qualify if:

• Patients previously or currently treated with other biological therapies.
• Use of etanercept for less than 1 year duration.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Baghdad, Iraq

Location

Related Links

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

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

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: August 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 28, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)