Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 60 Years|
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Assistance Publique - Hôpitaux de Paris|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||DRCD-Assistance Publique des Hôpitaux de Paris|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.