Arthritis, PsoriaticPSABRENCT06676176
Psoriatic Arthritis Pathobiology and Its Relationship With Clinical Disease Activity
An observational study of Arthritis, Psoriatic, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The study aims to examine the relationship between synovial histopathology and change in clinical disease activity over time in a population of patients with psoriatic arthritis who have failed to respond to first-line treatment. It is a prospective, open-labelled study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Psoriatic
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to 24 Jun 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational study of PsA patients who have persistent disease activity despite an adequate trial of standard non-biologic disease-modifying therapy, and who may proceed to receive their first or second biologic drug as the next treatment strategy.
Who may be able to join
- Men and women between 18 and 75 years of age inclusive;
- Patients with Psoriatic Arthritis as defined by the CASPAR criteria;
- Patients who have persistent active disease (defined as having 3 or more swollen and 3 or more tender joints) despite an adequate trial of 2 or more standard non-biologic disease-modifying drugs, administered either individually or in combination;
- Subjects who are naïve to biologic therapy or who have experienced but failed one previous class of biologic agent;
- The patient must be able to comply with the study visit schedule, treatment plans, lab tests and other study procedures;
- The patient must be capable of giving informed consent.
Who cannot join
- Women who are pregnant or breastfeeding;
- Men and women of childbearing potential who decline to employ adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study;
- As per care within a standard NHS setting, active infections of a serious nature such as HIV, HBV, pneumonia, or pyelonephritis are to be excluded. A history of previous serious infection is to be assessed individually for risk of re-activation, and a decision to treat (and with which agent) would be made according to the treating physician's discretion, as would normally occur within standard care. Less serious infections (such as upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator;
- Active TB, or evidence of latent TB without adequate therapy for TB, initiated prior to first dose of biologic. Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy. Patients with previous or current close contact with an individual with active TB, or history of active TB, and patients who have completed treatment for active TB should have had a thorough evaluation for TB prior to study enrolment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies;
- History of septic arthritis within a native joint within the last 12 months;
- Presence of a transplanted organ (with the exception of a corneal transplant occurring more than 3 months prior to screening);
Show all 12Show fewer
- Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated, with no evidence of recurrence);
- History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly;
- Known recent substance abuse (drug or alcohol);
- History of or current primary inflammatory joint disease or primary rheumatological autoimmune disease other than PsA;
- Poor tolerability of venepuncture required for blood sampling during the study period;
- Patients unable to tolerate synovial biopsy or in whom this is contraindicated (e.g. on anti-coagulants may not be suitable). However, assessment of suitability for the biopsy procedure will be a local decision.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to examine the relationship between synovial histopathology and change in clinical disease activity over time in a population of patients with psoriatic arthritis who have failed to respond to first-line treatment. It is a prospective, open-labelled study
- Conditions
- Arthritis, Psoriatic
- 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 |
|---|---|---|
| Observational | This study will be an observational study of a cohort of psoriatic arthritis patients who have failed to achieve sufficient response to standard non-biologic therapy. As they start their next treatment, this study aims to investigate the evolution of these patients in terms of the clinical, molecular and cellular profiles within the joint lining, peripheral blood and skin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS
The primary outcome measure is the Disease Activity Score (DAS), a composite score calculated using the Ritchie articular index (range 0-78), swollen joint count (range 0-44), patient--scored global health assessment on a visual analogue scale (range 0-100) and lab--measured erythrocyte sedimentation rate (ESR). This is used to assess the relationship between the level of interleukin(IL)-23 within the psoriatic arthritis synovium and clinical disease activity over time.
Measured: 4 months
Secondary outcomes (6)
Relationship between IL-23 levels within the PsA synovium/ skin and clinical disease activity
Measured: 4 months
Relationship between clinical disease activity and synovial, skin and/or blood levels of key immune signalling molecules involved in psoriatic disease
Such as but not limited to cluster of differentiation (CD)3, CD68, FVIII, TNFα, IL-1, IFN-γ, IL-6, IL-17A, IL-17R, IL-20, IL-22, IL-23/12p40, IL-23R, ICAM-1, VCAM-1, TGF-β, VEGF, PDGF, RANK-L, OPG, DKK-1, PNAd, CXCL13, CCL 21, MRP8 (S100A8), MRP14 (S100A9), Complement C3, TGFβ etc.
Measured: 4 months
Relationship, if any, between clinical disease characteristics and genotype
Measured: 4 months
Relationship between activated inflammatory cells in psoriatic skin and those in the psoriatic synovium
Measured: 4 months
Relationship between clinical disease activity and synovitis, assessed using grey scale with power doppler US imaging
Measured: 4 months
Relationship between clinical enthesitis scores (eg. LEI) and US scores of enthesitis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study startJun 2015
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies 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
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676176
- Sponsor's protocol ID
- 010368 BHT
- Acronym
- PSABRE
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2017
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriatic Arthritis Pathobiology and Its Relationship With Clinical Disease Activity
- ClinicalTrials.gov ID
- NCT06676176
- Acronym / sponsor ID
- PSABRE / 010368 BHT
- Conditions
- Arthritis, Psoriatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 6 Nov 2024 (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.
The study aims to examine the relationship between synovial histopathology and change in clinical disease activity over time in a population of patients with psoriatic arthritis who have failed to respond to first-line treatment. It is a prospective, open-labelled study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –This study will be an observational study of a cohort of psoriatic arthritis patients who have failed to achieve sufficient response to standard non-biologic therapy. As they start their next treatment, this study aims to investigate the evolution of these patients in terms of the clinical, molecular and cellular profiles within the joint lining, peripheral blood and skin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study of PsA patients who have persistent disease activity despite an adequate trial of standard non-biologic disease-modifying therapy, and who may proceed to receive their first or second biologic drug as the next treatment strategy.
Key inclusion criteria (6 listed)
- Men and women between 18 and 75 years of age inclusive;
- Patients with Psoriatic Arthritis as defined by the CASPAR criteria;
- Patients who have persistent active disease (defined as having 3 or more swollen and 3 or more tender joints) despite an adequate trial of 2 or more standard non-biologic disease-modifying drugs, administered either individually or in combination;
- Subjects who are naïve to biologic therapy or who have experienced but failed one previous class of biologic agent;
- The patient must be able to comply with the study visit schedule, treatment plans, lab tests and other study procedures;
Key exclusion criteria (12 listed)
- Women who are pregnant or breastfeeding;
- Men and women of childbearing potential who decline to employ adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study;
- As per care within a standard NHS setting, active infections of a serious nature such as HIV, HBV, pneumonia, or pyelonephritis are to be excluded. A history of previous serious infection is to be assessed individually for risk of re-activation, and a decision to treat (and with which agent) would be made according to the treating physician's discretion, as would normally occur within standard care. Less serious infections (such as upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator;
- Active TB, or evidence of latent TB without adequate therapy for TB, initiated prior to first dose of biologic. Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy. Patients with previous or current close contact with an individual with active TB, or history of active TB, and patients who have completed treatment for active TB should have had a thorough evaluation for TB prior to study enrolment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies;
- History of septic arthritis within a native joint within the last 12 months;
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
DAS
Time frame: 4 months
The primary outcome measure is the Disease Activity Score (DAS), a composite score calculated using the Ritchie articular index (range 0-78), swollen joint count (range 0-44), patient--scored global health assessment on a visual analogue scale (range 0-100) and lab--measured erythrocyte sedimentation rate (ESR). This is used to assess the relationship between the level of interleukin(IL)-23 within the psoriatic arthritis synovium and clinical disease activity over time.
6 secondary outcomes
Relationship between IL-23 levels within the PsA synovium/ skin and clinical disease activity
Time frame: 4 months
Relationship between clinical disease activity and synovial, skin and/or blood levels of key immune signalling molecules involved in psoriatic disease
Time frame: 4 months
Relationship, if any, between clinical disease characteristics and genotype
Time frame: 4 months
Relationship between activated inflammatory cells in psoriatic skin and those in the psoriatic synovium
Time frame: 4 months
Relationship between clinical disease activity and synovitis, assessed using grey scale with power doppler US imaging
Time frame: 4 months
Relationship between clinical enthesitis scores (eg. LEI) and US scores of enthesitis
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Arthritis, Psoriatic
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Psoriatic, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DAS (time frame: 4 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 6 Nov 2024.