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NCT Number: NCT03768271

APACHE Cohort (A Psoriatic Arthritis CoHort)

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

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Key information

Conditions

Cohort Study Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis (PsA) Recent Peripheral Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri-Mondor Hospital, Créteil, France

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About this study

Method:APACHE is a prospective national multicentre (30) cohort including and following during 10 years patients with a first peripheral arthritis in the past year, attributing to a PsA according to the treating rheumatologist. 425 patients will be included during a 4 years period before the follow-up. Standardized visits are planned throughout the 10 years follow-up, permitting the collection of various data:

  • clinical data
  • Patients Reported Outcome
  • usual lab parameters
  • plasma, serum and urines
  • Baseline and one year RNA, DNA
  • peripheral X-Rays, Ultrasounds and MRI at different time points Those visits have non interventional character (no therapeutic decision will be taken) Those collected data will allow submissions of many research projects to the scientific committee of the cohort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Percentage of patients with at least one erosion on the 5-years X-Rays

    Time frame: at 5 years

    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.

Secondary outcomes

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

    Time frame: at 5 years

    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.

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

    Time frame: at 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal CLAUDEPIERRE, PHD

CONTACT

[email protected]

01 49 81 47 04 ext. 0033

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)

Acronym: APACHE

Important dates

Study start
2020
Primary completion
2031
Study completion
2036
First posted
Dec 7, 2018
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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