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Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis (CARPAPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173039
Recruitment Status : Completed
First Posted : November 21, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Association pour la Recherche Clinique et Immunologique

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.

Condition or disease Intervention/treatment Phase
Psoriasis Arthritis, Psoriatic Diagnostic Test: Serum anti-CarP antibodies detection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : April 24, 2019


Arm Intervention/treatment
Controls
Patients with psoriasis and without psoriatic arthritis.
Diagnostic Test: Serum anti-CarP antibodies detection
Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.

Cases
Patients with psoriatic arthritis and with personal or familial psoriasis.
Diagnostic Test: Serum anti-CarP antibodies detection
Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173039


Locations
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France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Association pour la Recherche Clinique et Immunologique
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Responsible Party: Association pour la Recherche Clinique et Immunologique
ClinicalTrials.gov Identifier: NCT04173039    
Other Study ID Numbers: 18071A0003
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs