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Cohort StudyAPACHENCT03768271

APACHE Cohort (A Psoriatic Arthritis CoHort)

An observational study of Cohort Study and Psoriatic Arthritis (PsA), run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
425 participants
Where
3 sitesFrance
Study dates
12 Feb 2020to 1 Dec 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with peripheral psoriatic arthritis diagnosed at an early stage.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Cognitive, mental or psychic disorders impeding protocol accomplishment
  • Difficulties with French language understanding
  • Patient under tutorship or curatorship
  • Pregnancy

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pascal CLAUDEPIERRE, PHD contact

01 49 81 47 04 ext. 0033

pascal.claudepierre@aphp.fr

France3 sites, 3 recruiting

  • Henri-Mondor Hospital

    Créteil, 94000

    Pascal Claudepierre

    Recruiting

  • Lapeyronie Hospital

    Montpellier, 34090

    Cédric LUKAS

    Recruiting

  • Saint Joseph Hospital

    Paris, 75014

    Fabienne ROUX

    Recruiting

Other trials in France

About this study

Official title: French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (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.

Read more

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

Read the detailed description

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.
Keywords
radiographic lesions, 10 years cohort, Psoriatic arthritis
Medical subject headings
Arthritis, Psoriatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 5 years

Secondary outcomes (2)

  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.

    Measured: at 5 years

  2. 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.

    Measured: at 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2018
  2. Study start12 Feb 2020
  3. Primary completion1 Dec 2031 (estimated)
  4. Study completion1 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
425 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03768271
Sponsor's protocol ID
APHP180024
Acronym
APACHE
Status last verified
Apr 2026
First submitted
6 Dec 2018
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40441347

Questions about this trial

What is this clinical trial studying?

An observational study of Cohort Study and Psoriatic Arthritis (PsA), run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pascal CLAUDEPIERRE, PHD (01 49 81 47 04 ext. 0033, pascal.claudepierre@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with at least one erosion on the 5-years X-Rays (time frame: at 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03768271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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