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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

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


Condition or disease
Cohort Study Psoriatic Arthritis

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.

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Study Type : Observational
Estimated Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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
plasma, serum, urine, DNA, RNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with peripheral psoriatic arthritis diagnosed at an early stage.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Pascal CLAUDEPIERRE, PHD 01 49 81 47 04 ext 0033 pascal.claudepierre@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Isabelle VIVALDO DRCD-Assistance Publique des Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03768271     History of Changes
Other Study ID Numbers: APHP180024
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases