APACHE Cohort (A Psoriatic Arthritis CoHort)

NCT03768271 | Recruiting

• 1 other identifier: APHP180024
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Psoriatic Arthritis (PsA); Recent Peripheral Arthritis; Cohort Study

Keywords

radiographic lesions; 10 years cohort; Psoriatic arthritis

Outcome Measures

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.

  at 5 years

Secondary Outcomes (2)

• Percentage of patients with at least one joint space narrowing and one periostitic lesion on the 5-years X-Rays.

  at 5 years

• Percentage of patients with at least one erosion, joint space narrowing, periostitic lesion, on the 10-years X-Rays.

  at 10 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral psoriatic arthritis diagnosed at an early stage.

You may qualify if:

• 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)
• Signed informed consent form
• Affiliation to a social security system

You may not qualify if:

• 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
• intravenous or intra articular steroids in the last 4 weeks
• IRM contraindication
• Cognitive, mental or psychic disorders impeding protocol accomplishment
• Difficulties with French language understanding
• Patient under tutorship or curatorship
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Henri-Mondor Hospital

Créteil, 94000, France

RECRUITING

Lapeyronie Hospital

Montpellier, 34090, France

RECRUITING

Saint Joseph Hospital

Paris, 75014, France

RECRUITING

Related Publications (1)

• Claudepierre P, Gaujoux-Viala C, Constantin A, Berenbaum F, Combe B, Devauchelle V, Goupille P, Richette P, Wendling D, Mouterde G, Pascart T, Razat B, Audureau E, Jousse-Joulin S, Gossec L. Early peripheral psoriatic arthritis: Baseline features of the first 186 patients in the French Nationwide APACHE Cohort. Joint Bone Spine. 2025 Dec;92(6):105930. doi: 10.1016/j.jbspin.2025.105930. Epub 2025 May 27.

  PMID: 40441347 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, urine, DNA, RNA.

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Isabelle VIVALDO

  DRCD-Assistance Publique des Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Pascal CLAUDEPIERRE, PHD

CONTACT

01 49 81 47 04; pascal.claudepierre@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: February 12, 2020
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2036
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)