Back to resultsAnti-Carbamylated Protein Antibodies in Psoriatic Arthritis (CARPAPA)
Primary Purpose
Psoriasis, Arthritis, Psoriatic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serum anti-CarP antibodies detection
Sponsored by
About this trial
This is an interventional diagnostic trial for Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Controls
Cases
Arm Description
Patients with psoriasis and without psoriatic arthritis.
Patients with psoriatic arthritis and with personal or familial psoriasis.
Outcomes
Primary Outcome Measures
Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population
Secondary Outcome Measures
Full Information
NCT ID
NCT04173039
First Posted
November 20, 2019
Last Updated
November 21, 2019
Sponsor
Association pour la Recherche Clinique et Immunologique
1. Study Identification
Unique Protocol Identification Number
NCT04173039
Brief Title
Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis
Acronym
CARPAPA
Official Title
Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
April 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour la Recherche Clinique et Immunologique
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Arthritis, Psoriatic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controls
Arm Type
Other
Arm Description
Patients with psoriasis and without psoriatic arthritis.
Arm Title
Cases
Arm Type
Other
Arm Description
Patients with psoriatic arthritis and with personal or familial psoriasis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum anti-CarP antibodies detection
Intervention Description
Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.
Primary Outcome Measure Information:
Title
Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population
Time Frame
Anti-CarP antibodies will be assessed in the sera collected at the recruitment visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Learn more about this trial
Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis
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