Modified PEST Screening for Psoriatic Arthritis

(ScreenX Trial)

Recruiting at 9 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Novartis Pharmaceuticals

Must not be taking: bDMARDs

Disqualifiers: PsA, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

502 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding two questions and pictures to a screening tool can help identify psoriatic arthritis (joint pain related to psoriasis) in individuals with moderate-to-severe plaque psoriasis in Canada. Participants will answer questions about symptoms such as morning stiffness and nighttime pain and view pictures of common signs like swollen joints and fingernail issues. The trial seeks participants with moderate-to-severe plaque psoriasis who are considering biologic treatments. It excludes those already diagnosed with psoriatic arthritis or receiving certain medications. As an unphased trial, this study offers a unique opportunity to contribute to improving early detection methods for psoriatic arthritis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently treated with a bDMARD for moderate-to-severe plaque PsO or any other condition, you cannot participate in the trial.

What prior data suggests that this screening method is safe for diagnosing Psoriatic Arthritis?

A previous study demonstrated that the PEST screening tool, which identifies psoriatic arthritis (PsA) in people with psoriasis, is safe. The tool involves answering simple questions. The updated version, PEST+pictures+2, includes additional questions and pictures for easier understanding. This questionnaire requires no medication, eliminating the risk of drug side effects.

Research has shown that the PEST tool is well-tolerated because it is non-invasive, involving only questions without any physical procedures. Its safety is supported by its use in many studies, where it has proven reliable and harmless. Participants can feel confident about the safety of using PEST+pictures+2 in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because the Modified PEST Screening for Psoriatic Arthritis offers a fresh approach to early detection of psoriatic arthritis (PsA) in patients with psoriasis. Unlike the standard methods, which often rely solely on patient history and physical exams, this screening tool combines the PEST questionnaire with visual aids and additional targeted questions. By incorporating pictures of common PsA symptoms and asking about specific experiences like morning stiffness and nighttime pain, this method aims to catch cases that might otherwise go unnoticed. This could lead to earlier intervention and better management of the condition, potentially improving patient outcomes.

What evidence suggests that this modified PEST screening is effective for diagnosing psoriatic arthritis?

Research has shown that the PEST (Psoriasis Epidemiology Screening Tool) effectively identifies psoriatic arthritis (PsA) early in individuals with psoriasis. This tool uses five simple questions to check for PsA. In this trial, participants will undergo screening with an updated version called PEST+pictures+2. This version includes two additional questions about morning stiffness and nighttime pain, along with pictures of symptoms like swollen joints. The goal is to identify undiagnosed PsA in patients with moderate-to-severe plaque psoriasis. Early detection is crucial because PsA often goes unnoticed in people with psoriasis. ^{1 6 7 8 9}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults in Canada with moderate-to-severe plaque psoriasis who might need biologic DMARDs (a type of medication). Participants should understand and be willing to follow the study's rules.

Inclusion Criteria

I live in Canada.

I have severe plaque psoriasis and qualify for biological treatments.

I am an adult who has signed the informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Dermatologist Visit

Participants fill out the PsA screening questionnaire using PEST+pictures+2 at their first dermatologist visit

1 day

1 visit (in-person)

Rheumatologist Assessment

Participants screening positive for PsA have a second visit with a rheumatologist for a full PsA diagnosis assessment

1 day

1 visit (in-person)

End of Study (EOS) Visit

A remote 'end of study' visit is conducted by the dermatologist to document the patient's bDMARDs treatment choice and status

1 day

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the initial screening and assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PEST Screening group

Trial Overview The study is testing a modified PEST screening tool, which includes additional questions and pictures, to see if it helps diagnose Psoriatic Arthritis in people with severe plaque psoriasis more effectively.

How Is the Trial Designed?

Group I: PEST Screening group Experimental Treatment 1 Intervention

When visiting their dermatologists, all eligible patients with moderate-to-severe plaque psoriasis (PsO) eligible for treatment with biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) will be screened for psoriatic arthritis (PsA) using PEST+pictures+2, a variation of the PEST screening tool. The PEST+pictures+2 is made up of 3 components: 1. Psoriasis Epidemiology Screening Tool (PEST) consisting of 5 simple questions 2. PEST+2 refers to the PEST modified with two additional questions (Do you have morning stiffness that lasts for more than one (1) hour? Do you wake up at night because of low back or buttock pain?), AND 3. PEST+pictures which provides an opportunity for patients to modify their answers to PEST questions 1, 3, and 5 by presenting them with pictures of swollen joints, fingernail pitting, and swollen fingers and toes.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6593969/

Utilization of the validated Psoriasis Epidemiology Screening ... The validated Psoriasis Epidemiology Screening Tool (PEST) is a five‐item questionnaire developed to help identify PsA at an early stage.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06382051?locn=Ontario&locStr=Canada&country=Canada&aggFilters=status%3Arec

Modifying PEST for Psoriatic Arthritis Screening The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11971091/

Analysis of PEST Questionnaire Responses in Patients ... The PEST questionnaire is a well-established screening tool for identifying patients at risk of having undiagnosed psoriatic arthritis in daily dermatological ...

4. academic.oup.com academic.oup.com/rheumatology/article/63/4/991/7204436

comparative performance of three screening questionnaires ... The objective of this study was to compare the performance of three PsA screening questionnaires in a primary care psoriasis surveillance study.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724215338

High prevalence of psoriatic arthritis in patients with severe ... Our study confirms the high prevalence of PsA in patients with psoriasis with severity of skin involvement as a useful predictor. Poor sensitivity performance ...

6. novartis.com novartis.com/clinicaltrials/study/nct06382051

Modifying PEST for Psoriatic Arthritis Screening A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis ...

7. pcds.org.uk pcds.org.uk/files/gallery/The_PEST_screening_questionnaire_updated_aug_2013_v5_1.pdf

PSORIASIS EPIDEMIOLOGY SCREENING TOOL (PEST) PEST is a validated screening tool for psoriatic arthritis (PsA) and it is recommended that patients with psoriasis who do not have a diagnosis of PsA ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8791553/

Telemedicine and psoriatic arthritis - PubMed Central - NIH ... Screening Tool (PEST) questionnaire. Clin Exp Rheumatol. 2009;27(3):469–474. [PubMed] [Google Scholar]; 34. Chang CA, Gottlieb AB, Lizzul PF ...

9. researchgate.net researchgate.net/publication/26672879_Evaluation_of_an_existing_screening_tool_for_psoriatic_arthritis_in_people_with_psoriasis_and_the_development_of_a_new_instrument_The_Psoriasis_Epidemiology_Screening_Tool_PEST_questionnaire

Evaluation of an existing screening tool for psoriatic ... The Psoriasis Epidemiology Screening Tool (PEST) questionnaire was developed as a tool to screen patients with psoriasis for PsA and comprises ...