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Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study

NCT ID: NCT05925842

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-25

Study Completion Date

2024-09-30

Brief Summary

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Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants with PsA without Axial Involvement

No interventions assigned to this group

Participants with PsA with Axial Involvement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Persons with PsA diagnosed by a consultant Rheumatologist with disease duration of \> 3 months but \< 10 years with or without IBP.

* Adults between the ages 18 and 80 years, with joint disease onset after 16 years of age
* Patients able to understand and complete consent procedures
* Study participants must have PsA, meet CASPAR criteria, and must have active disease as defined by the treating rheumatologist, including an evaluable psoriatic skin lesion amenable to 6mm punch skin biopsy.

o Psoriasis should be diagnosed by a consultant rheumatologist or dermatologist.
* Study participants must have been on consistent therapy for their PsA for the past 90 days
* Study participants must be naïve to biological treatment and targeted synthetic DMARD treatment (examples: JAK inhibitors, apremilast)

Exclusion Criteria

* • Persons with musculoskeletal (peripheral or axial) symptoms for \>10 years

* Persons with planned major surgery (e.g., joint replacement) within the duration of the collection of data for the study
* Persons with a history of chemotherapy, radiation therapy or immunotherapy for cancer in the preceding 5 years.
* Persons with ongoing cancer (not excluding non-melanoma skin, cervical/breast in-situ carcinoma) but those fully recovered from an episode of cancer (in remission for more than 5 years) may be included at the discretion of the patient's treating rheumatologist.
* Persons with an active severe or serious infection
* Patients with non-severe infection at the discretion of the Investigator
* Persons with other concomitant disorders incompatible with study (at discretion of Investigator).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Mease, MD

Role: PRINCIPAL_INVESTIGATOR

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Vinod Chandran, MD

Role: STUDY_DIRECTOR

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Oliver Fitzgerald, MD

Role: STUDY_DIRECTOR

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Seattle Rheumatology Associates

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MAXPSA001

Identifier Type: -

Identifier Source: org_study_id