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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date December 6, 2018
First Posted Date December 7, 2018
Last Update Posted Date April 3, 2019
Estimated Study Start Date June 1, 2019
Estimated Primary Completion Date March 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03768271 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 6, 2018)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title APACHE Cohort (A Psoriatic Arthritis CoHort)
Official Title French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)
Brief 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

Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
plasma, serum, urine, DNA, RNA.
Sampling Method Non-Probability Sample
Study Population Patients with peripheral psoriatic arthritis diagnosed at an early stage.
Condition
  • Cohort Study
  • Psoriatic Arthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 6, 2018)
425
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2031
Estimated Primary Completion Date March 1, 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pascal CLAUDEPIERRE, PHD 01 49 81 47 04 ext 0033 pascal.claudepierre@aphp.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03768271
Other Study ID Numbers APHP180024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Study Chair: Isabelle VIVALDO DRCD-Assistance Publique des Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2018