APACHE Cohort (A Psoriatic Arthritis CoHort)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease, belonging to the wide spectrum of spondyloarthritis, but with the particularity to be associated with personal psoriasis or familial psoriasis. PsA can be a very disabling disease through progressive and irreversible joint damage. Long-term functional prognosis of patients with PsA is correlated with the presence and severity of the radiographic joint lesions of the disease.
However, the proportion of patients who will develop those peripheral joint damages is not yet known and less over the factors which are associated/involved in such an aggressive pattern of the disease. Early identification of this subgroup of patients is particularly important for determining early "intensive" treatment, strict management with a Treat To Target approach, and identification of new treatments with a stronger structural effect.
The main objective of this prospective 10 years cohort is to describe the 5 years structural (radiographic) severity of recent Psoriatic arthritis (PsA)with recent peripheral arthritis.Some of the secondary objectives are to describe the 10 years structural severity within those patients, and to determine the predictive factors of those 5 and 10 years radiographic lesions (genetic, environmental, clinic, therapeutic factors).
APACHE will provide a unique longitudinal standardized database concerning patients with PsA with very recent peripheral arthritis. Research projects which will based on those collected data should allow to identify the mechanisms of aggressive joint damage, to highlight mew treatments targets, to better describe the burden of the disease, to test previous or develop new assessments tolls, to develop early diagnostic criteria
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women or men aged from 18 to 65 inclusive
First episode of peripheral arthritis in the last 12 months, authenticated by a rheumatologist
Psoriasis diagnosed by a practitioner or family history of psoriatic arthritis (first-degree relative [parent or sibling] or second degree relative)
Arthritis most likely recognized as a psoriatic arthritis by a rheumatologist (diagnostic confidence score : ≥ 7 out of 10)
Disqualifiers
Formal diagnostic of inflammatory rheumatism other than psoriatic arthritis
Treatment or history of treatment with a biomedicine
Patient receiving csDMARDS (methotrexate, sulfasalazine, or leflunomide) or apremilast treatment over the past year for rheumatological symptoms
Oral steroids in the last 4 weeks, above 10 mg/d of prednisone or with modified dosage
Trial population
Patients with peripheral psoriatic arthritis diagnosed at an early stage.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Percentage of patients with at least one erosion on the 5-years X-Rays
The primary endpoint is the presence / absence of at least one erosion on at least one of the 5-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline. The assessment of erosions will be done by 3 trained readers.
Time frame
at 5 yearsSecondary outcomes
1
Percentage of patients with at least one joint space narrowing and one periostitic lesion on the 5-years X-Rays.
this endpoint is the presence of at least one joint space narrowing and one periostitic lesion on at least one of the 5-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline. The assessment of erosions will be done by 3 trained readers.
Time frame
at 5 years2
Percentage of patients with at least one erosion, joint space narrowing, periostitic lesion, on the 10-years X-Rays.
this endpoint is the presence of at least one erosion, joint space narrowing, periostitic lesion, on at least one of the 10-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline. The assessment of erosions will be done by 3 trained readers.
Time frame
at 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov