This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.

NCT04267614 | Completed Results

• 1 other identifier: B1801411
• Study Type: observational
• Target: 1,226
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the effect of etanercept in early versus delayed referral for management of rheumatoid arthritis patients assessing real-world patient data entered in the Iraq National Center of Rheumatology database between May 2012 and May 2017.

Conditions

Arthritis Rheumatoid

Outcome Measures

Primary Outcomes (2)

• Disease Activity Score 28 (DAS28) at Month 12

  DAS28 was calculated from the number of swollen joints (SJC) and painful joints (PJC) using 28 joints count, the erythrocyte sedimentation rate (ESR) (in millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA.

  Month 12 (from the data retrieved and observed during 1 month of this study)

• Clinical Disease Activity Index (CDAI) Score at Month 12

  The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, PGA and physician global assessment (PhGA) assessed on 0 to 10 centimeter (cm) visual analog scale (VAS); higher scores = high disease activity. CDAI total score = 0 to 76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \> 10 to 22 = moderate disease activity and \> 22 = high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA.

  Month 12 (from the data retrieved and observed during 1 month of this study)

Other Outcomes (2)

• Mean Change From Baseline in DAS28 at Month 12

  Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)

• Mean Change From Baseline in CDAI Score at Month 12

  Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)

Study Arms (1)

Patients with Rheumatoid Arthritis (RA)

Patients receiving etanercept from Baghdad teaching hospital registry(Rheumatology center) from 2012 till 2017. Patients were identified as receiving early versus delayed etanercept treatment.

Drug: Etanercept

Interventions

Etanercept DRUG

Patients who received etanercept for RA

Patients with Rheumatoid Arthritis (RA)

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected from the Baghdad teaching hospital registry. The Rheumatology patient registry is a prospective longitudinal multicentre cohort initiated in 2012.

You may qualify if:

• Diagnosed RA patients.
• years old and above.
• Did not receive pervious biological treatment.

You may not qualify if:

• Had previous biological treatment
• Use etanercept for less than 1 year

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Baghdad, Iraq

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System 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: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: November 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 7, 2023
• Results First Posted: July 7, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)