NCT04173039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

November 20, 2019

Last Update Submit

November 21, 2019

Conditions

PsoriasisArthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Controls

OTHER

Patients with psoriasis and without psoriatic arthritis.

Diagnostic Test: Serum anti-CarP antibodies detection

Cases

OTHER

Patients with psoriatic arthritis and with personal or familial psoriasis.

Diagnostic Test: Serum anti-CarP antibodies detection

Interventions

Serum anti-CarP antibodies detectionDIAGNOSTIC_TEST

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

CasesControls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • "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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

PsoriasisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 21, 2019

Study Start

August 29, 2018

Primary Completion

April 24, 2019

Study Completion

April 24, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

FR(1)