APACHE Cohort (A Psoriatic Arthritis CoHort)

Psoriatic Arthritis Clinical Trial

— APACHE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03768271
• Other study ID #: APHP180024
• Status: Recruiting
• Start date: February 12, 2020
• Est. completion date: March 1, 2034

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Pascal CLAUDEPIERRE, PHD
• Phone: 01 49 81 47 04
• Email: pascal.claudepierre[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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 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

Description:

Method:APACHE is a prospective national multicentre (29) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 425
• Est. completion date: March 1, 2034
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women or men aged from 18 to 60 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 or apremilast treatment for 1 year or more

• Patient having received csDMARDS or apremilast treatment during the last 12 months

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Cohort Study
• Psoriatic Arthritis

Locations

Country	Name	City	State
France	Henri-Mondor Hospital	Créteil
France	Lapeyronie Hospital	Montpellier
France	Saint Joseph Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	at 5 years
Secondary	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.	at 10 years