Modified PEST Screening for Psoriatic Arthritis

(ScreenX Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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 with moderate-to-severe plaque PsO in Canada.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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