Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients

Arthritis, Rheumatoid Clinical Trial

Official title:

The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04428424
• Other study ID #: B1801417
• Status: Completed
• Start date: July 5, 2020
• Est. completion date: August 30, 2020

Study information

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

Clinical Trial Summary

This study is to evaluate available local data in Iraqi patients with rheumatoid arthritis on Enbrel treatment with regards to the impact of Rheumatoid factor and Anti-cyclic citrullinated peptide using data from the Baghdad Teaching Hospital registry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1493
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed RA patients.

-=18 years of age

• Did not receive previous another biological treatment

Exclusion Criteria:

• Had previous biological treatment

• Use of etanercept for less than 1 year

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Enbrel
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
Primary	Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)	DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 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 equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. DAS28 score in participants with positive RF and ACCP were reported in this outcome measure.	Month 12 visit during retrospective data collection period of approximately 7 years
Primary	Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (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. CDAI score in participants with positive RF and ACCP were reported in this outcome measure.	Month 12 visit during retrospective data collection period of approximately 7 years
Primary	Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)	DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (in mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 <= 3.2 = low disease activity, DAS28 > 3.2 to 5.1 = moderate to high disease activity. DAS28 score in participants with negative RF and ACCP were reported in this outcome measure.	Month 12 visit during retrospective data collection period of approximately 7 years
Primary	Clinical Disease Activity Index (CDAI) Score in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and PhGA assessed on 0 to 10 cm 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. CDAI score in participants with negative RF and ACCP were reported in this outcome measure.	Month 12 visit during retrospective data collection period of approximately 7 years

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