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NCT04173039 Clinical Trial

Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis

Psoriasis Clinical Trial

— CARPAPA  

Official title:
Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04173039
Other study ID # 18071A0003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 29, 2018
Est. completion date April 24, 2019

Study information
Verified date November 2019
Source Association pour la Recherche Clinique et Immunologique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 24, 2019
Est. primary completion date April 24, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- "Controls" : Patients with a psoriasis confirmed by a dermatologist and with absence of psoriatic arthritis confirmed by a rheumatologist.

- "Cases" : Patients with psoriatic arthritis fulfilling the classification criteria for psoriatic arthritis (CASPAR), with a diagnosis confirmed by a rheumatologist and associated with personal or familial psoriasis.

Exclusion Criteria:

- "Controls": Presence of any chronic rheumatic inflammatory disease such as psoriatic arthritis.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Serum anti-CarP antibodies detection
Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.

Locations
Country Name City State
France Centre Hospitalier Lyon Sud Pierre-Bénite

Sponsors (1)
Lead Sponsor Collaborator
Association pour la Recherche Clinique et Immunologique

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population Anti-CarP antibodies will be assessed in the sera collected at the recruitment visit
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