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

June 22, 2023 updated by: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
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

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
    • Washington
      • Seattle, Washington, United States, 98122
        • Seattle Rheumatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult persons with diagnosed active PsA including psoriatic lesions, naive to biologic or tsDMARD therapies

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants with PsA without Axial Involvement
Participants with PsA with Axial Involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target biomarker identification
Time Frame: 18 months
Identify candidate biomarkers able to discriminate between PsA with and without axial involvement
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAXPSA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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