Psoriatic ArthritisMONOLITHNCT05925842
Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study
An observational study of Psoriatic Arthritis, run by Group for Research and Assessment of Psoriasis and Psoriatic Arthritis at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult persons with diagnosed active PsA including psoriatic lesions, naive to biologic or tsDMARD therapies
Who may be able to join
- 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)
Who cannot join
- • 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego
La Jolla, California, 92093
Seattle Rheumatology Associates
Seattle, Washington, 98122
About this study
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
- Conditions
- Psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with PsA without Axial Involvement | Not described | |
| Participants with PsA with Axial Involvement | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target biomarker identification
Identify candidate biomarkers able to discriminate between PsA with and without axial involvement
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start25 Jan 2023
- Primary completionFeb 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Philip Mease, MD, Principal investigator, Group for Research and Assessment of Psoriasis and Psoriatic ArthritisVinod Chandran, MD, Study director, Group for Research and Assessment of Psoriasis and Psoriatic ArthritisOliver Fitzgerald, MD, Study director, Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925842
- Sponsor's protocol ID
- MAXPSA001
- Acronym
- MONOLITH
- Status last verified
- Jun 2023
- First submitted
- 10 May 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study
- ClinicalTrials.gov ID
- NCT05925842
- Acronym / sponsor ID
- MONOLITH / MAXPSA001
- Conditions
- Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Group for Research and Assessment of Psoriasis and Psoriatic ArthritisResearch network
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with PsA without Axial Involvement | – | – |
| Participants with PsA with Axial Involvement | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult persons with diagnosed active PsA including psoriatic lesions, naive to biologic or tsDMARD therapies
Key inclusion criteria (7 listed)
- Persons with PsA diagnosed by a consultant Rheumatologist with disease duration of > 3 months but < 10 years with or without IBP.
- o Psoriasis should be diagnosed by a consultant rheumatologist or dermatologist.
Key exclusion criteria (7 listed)
- • Persons with musculoskeletal (peripheral or axial) symptoms for >10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target biomarker identification
Time frame: 18 months
Identify candidate biomarkers able to discriminate between PsA with and without axial involvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Mease, MD principal investigator
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
Vinod Chandran, MD study director
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
Oliver Fitzgerald, MD study director
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Group for Research and Assessment of Psoriasis and Psoriatic Arthritis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target biomarker identification (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.