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

Sponsor
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05925842
Collaborator
(none)
40
Enrollment
2
Locations
19.2
Anticipated Duration (Months)
20
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study
    Actual Study Start Date :
    Jan 25, 2023
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Participants with PsA without Axial Involvement
    Participants with PsA with Axial Involvement

    Outcome Measures

    Primary Outcome Measures

    1. Target biomarker identification [18 months]

      Identify candidate biomarkers able to discriminate between PsA with and without axial involvement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Diego La Jolla California United States 92093
    2 Seattle Rheumatology Associates Seattle Washington United States 98122

    Sponsors and Collaborators

    • Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

    Investigators

    • Principal Investigator: Philip Mease, MD, Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
    • Study Director: Vinod Chandran, MD, Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
    • Study Director: Oliver Fitzgerald, MD, Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
    ClinicalTrials.gov Identifier:
    NCT05925842
    Other Study ID Numbers:
    • MAXPSA001
    First Posted:
    Jun 29, 2023
    Last Update Posted:
    Jun 29, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Psoriatic

    Study Results

    No Results Posted as of Jun 29, 2023