Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: Enbrel

• Registration Number: NCT04428502
• Lead Sponsor: Pfizer

Brief Summary

This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist in Baghdad Teaching Hospital registry.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Study Start: 2020-07-05
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2021-08
• Results First Submitted: 2021-08-17
• Results First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Results First Posted: 2021-09-14
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• Diagnosed PsA patients.
• ≥18 years of age
• Have not received previous biological treatment

Exclusion Criteria

• Previous use of other biological treatments.
• Etanercept use for less than 1 year duration.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with psoriatic arthritis	Enbrel	Iraqi patients diagnosed with psoriatic arthritis that receive Enbrel as treatment for disease

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12	Baseline, Month 12	DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1	Baseline, Month 1	DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.

Trial Locations

Locations (1)

Pfizer; 🇮🇶 Baghdad, Iraq