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APACHE Cohort (A Psoriatic Arthritis CoHort)

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03768271

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Assistance Publique - Hôpitaux de Paris

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Isabelle VIVALDO
Principal Investigator Affiliation DRCD-Assistance Publique des Hôpitaux de Paris

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Not yet recruiting
Countries

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Cohort Study, Psoriatic Arthritis
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Pascal CLAUDEPIERRE, PHD

[email protected]

01 49 81 47 04

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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