APACHE Cohort (A Psoriatic Arthritis CoHort) (APACHE)
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|ClinicalTrials.gov Identifier: NCT03768271|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : April 3, 2019
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
|Condition or disease|
|Cohort Study Psoriatic Arthritis|
Method:APACHE is a prospective national multicentre (26) 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 2 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.
|Study Type :||Observational|
|Estimated Enrollment :||425 participants|
|Official Title:||French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||March 1, 2026|
|Estimated Study Completion Date :||March 1, 2031|
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768271
|Contact: Pascal CLAUDEPIERRE, PHD||01 49 81 47 04 ext firstname.lastname@example.org|
|Study Chair:||Isabelle VIVALDO||DRCD-Assistance Publique des Hôpitaux de Paris|