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Clinical Trials/NCT04428502
NCT04428502CompletedNot Applicable

Correlation of Anti-CCP With Disease Activity and Its Impact on Biological Response in PsA in Iraqi Patients

Pfizer1 site in 1 country127 target enrollmentStarted: July 5, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Pfizer
Enrollment
127
Locations
1
Primary Endpoint
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Patients with psoriatic arthritis

Iraqi patients diagnosed with psoriatic arthritis that receive Enbrel as treatment for disease

Intervention: Enbrel (Drug)

Outcomes

Primary Outcomes

Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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