Clinical and Molecular Characterization of Axial Psoriati... | NCT05925842

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

NCT05925842

Sponsor

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Status

Unknown status

Last Update Posted

Jun 29, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Psoriatic Arthritis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2023Actual

Primary Completion Date

Feb 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

May 10, 2023

First Submission Date that Met QC Criteria

Jun 22, 2023

First Posted Date

Jun 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2023

Last Update Posted Date

Jun 29, 2023Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

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

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Mease, MD	Group for Research and Assessment of Psoriasis and Psoriatic Arthritis	Principal Investigator
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 Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego		La Jolla	California	92093	United States
Seattle Rheumatology Associates

Label	Type	Description	Intervention Names
Participants with PsA without Axial Involvement
Participants with PsA with Axial Involvement

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases