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

NCT04428502 | Completed Results

• 1 other identifier: B1801418
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at 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.

  Baseline, Month 1

• Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at 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.

  Baseline, Month 12

Other Outcomes (1)

• Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12

  Month 1, 6 and 12

Study Arms (1)

Patients with psoriatic arthritis

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

Drug: Enbrel

Interventions

Enbrel DRUG

As provided in real world practice

Patients with psoriatic arthritis

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 the local Rheumatology Center of Baghdad Teaching Hospital registry

You may qualify if:

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

You may not qualify if:

• Previous use of other biological treatments.
• Etanercept use 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

Arthritis, Psoriatic

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue 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: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 11, 2020
• Study Start: July 5, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: September 14, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)