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PsoriasisPROGRESS-RONCT07582783

A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania

An observational study of Psoriasis, run by Janssen Research & Development, LLC at 20 sites in Romania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
How many people
200 participants
Where
20 sitesRomania
Study dates
15 May 2026to 10 Nov 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with moderate-to-severe plaque psoriasis, in accordance with clinical practice in Romania, who have never been treated with biological treatment before will be observed.

Who may be able to join

  • Has a confirmed diagnosis of moderate-to-severe plaque psoriasis
  • Participant must sign an informed consent form allowing source data verification in accordance with local requirements
  • Is able to read, understand, and complete the patient reported outcomes (PRO) instruments in local language and comply with completion of all PRO instruments
  • No previous exposure to biological treatment, including guselkumab (bio-naive patient)
  • Intended for the treatment with guselkumab according to the approved indication

Who cannot join

  • Meets any of the contraindications according to the latest version of the locally approved summary of product characteristics (SmPC)
  • Is pregnant or lactating
  • Current or recent (in the last 30 days prior to first SC dose of guselkumab) participation in any interventional study with investigational product.
  • Currently enrolled in another observational study sponsored or managed by a Johnson \& Johnson company

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

20 sites in 1 country

Romania20 sites, 20 recruiting
  • Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie

    Bârlad, 731139

    Recruiting
  • Qualimed SRL

    Brasov, 500073

    Recruiting
  • Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie

    Bucharest, 011461

    Recruiting
  • Spitalul Clinic Colentina 1

    Bucharest, 020125

    Recruiting
  • Spitalul Clinic Colentina

    Bucharest, 020125

    Recruiting
  • Alin Nicolescu Medic Primar Dermato Venerologie

    Bucharest, 030167

    Recruiting
  • OptiDerm Estet

    Bucharest, 111870

    Recruiting
  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006

    Recruiting
  • Ambulator Specialitate Sp Militar de Urgenta Dr Constantin Papilian Cluj Napoca

    Cluj-Napoca, 400132

    Recruiting
  • Innovative Derm SRL

    Constanța, 900562

    Recruiting
  • MC Medica SRL

    Craiova, 200061

    Recruiting
  • Policlinica Dr.Corbeanu

    Craiova, 200157

    Recruiting
  • Policlinica Top Med Buna Vestire

    Craiova, 200330

    Recruiting
  • Derma Lux SRL

    Iași, 700126

    Recruiting
  • Spitalul Clinic Judetean de Urgenta Bihor

    Oradea, 410167

    Recruiting
  • Derma Lux SRL 1

    Reghin, 545300

    Recruiting
  • Evaderm Health SRL

    Slatina, 230086

    Recruiting
  • Spitalul Judetean de Urgenta 'Sf.Ioan cel Nou', Sectia Oncologie

    Suceava, 720224

    Recruiting
  • Clinica Cabimed

    Târgu-Mures, 540119

    Recruiting
  • Dr Tirziu Dermato Chirurgie SRL

    Timișoara, 300188

    Recruiting

Other trials in Romania

About this study

Official title: Persistence to Treatment With Guselkumab in Bio-Naive Patients With Moderate-to-Severe Plaque Psoriasis: A Romanian Non-Interventional Multi-center Observational Study

This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.

Conditions
Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07582783
Study groupRoleWhat they receive
Group 1: Participants with Moderate-to-Severe Plaque PsoriasisParticipants with confirmed diagnosis of moderate-to-severe plaque psoriasis who have never been treated with biological treatment before, and receiving guselkumab as per routine clinical practice will be enrolled. Only data available per clinical practice will be collected within this study. The primary data source for this study will be the medical records of each participant.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Guselkumab Discontinuation Throughout 2 Years

    Time to guselkumab discontinuation is defined as the time (days) from the date of the first guselkumab administration to the date of the last administered dose preceding permanent cessation.

    Measured: Up to 2 years

Secondary outcomes (15)
  1. Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Scores Among Participants Remaining on Treatment

    Percentage of participants achieving absolute PASI scores less than or equal to (<=) 1, 2, 3 and 5, and PASI = 0 among participants remaining on treatment will be reported. In the PASI system, the body is divided into 4 areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that range from 0 to 6, and for erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating more severe psoriasis.

    Measured: At Weeks 12, 24, 52 and 104

  2. Percentage of Participants Achieving PASI 90 Response Score

    PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline. In the PASI system, the body is divided into 4 areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that range from 0 to 6, and for erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating more severe psoriasis.

    Measured: At Weeks 0, 12, 24, 52 and 104

  3. Percentage of Participants Achieving PASI 75 Response Score

    PASI 75 response is defined as >= 75% improvement in PASI score from baseline. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.

    Measured: At Weeks 0, 12, 24, 52 and 104

  4. Percentage of Participants Achieving PASI 100 Response Score

    PASI 100 response is defined as >= 100% improvement in PASI score from baseline. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.

    Measured: At Weeks 0, 12, 24, 52 and 104

  5. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1

    The DLQI is a 10-item questionnaire that can be used to assess overall quality-of-life and 6 different aspects that may affect quality-of-life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on quality-of-life.

    Measured: At Weeks 0, 12, 24, 52 and 104

  6. Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1

    The IGA scale is a visual assessment that consists of a score ranging from 0 (clear) to 4 (severe). The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Skin rated as "4" is bright red in color with marked plaque elevation and is dominated by thick, non-tenacious scale. For treatment to be considered successful, the affected area must receive a score of 0 or 1 and experience a two-point improvement from baseline.

    Measured: At Weeks 0, 12, 24, 52 and 104

  7. Percentage of Participants Achieving IGA Score of 0

    The IGA scale is a visual assessment that consists of a score ranging from 0 (clear) to 4 (severe). The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Skin rated as "4" is bright red in color with marked plaque elevation and is dominated by thick, non-tenacious scale. For treatment to be considered successful, the affected area must receive a score of 0 or 1 and experience a two-point improvement from baseline.

    Measured: At Weeks 0, 12, 24, 52 and 104

  8. Participant Baseline Characteristics: Age

    Participant's age at the time of starting guselkumab treatment will be reported.

    Measured: Baseline

  9. Participant Baseline Characteristics: Gender

    Gender (male, female) of participants at the time of starting guselkumab treatment will be reported.

    Measured: Baseline

  10. Participant Baseline Characteristics: Height

    Height of participants at the time of starting guselkumab treatment will be reported.

    Measured: Baseline

  11. Participant Baseline Characteristics: Weight

    Weight of participants at the time of starting guselkumab treatment will be reported.

    Measured: Baseline

  12. Number of Participants Reporting Disease Severity

    Number of participants with disease severity will be reported.

    Measured: Baseline

  13. Number of Participants Reporting Smoking History and Alcohol Use

    Number of participants reporting smoking history and alcohol use will be reported.

    Measured: Baseline

  14. Hazard Ratio Between Baseline Factors and Time to Guselkumab Treatment Discontinuation

    Hazard Ratio Between Baseline Factors and time to Guselkumab treatment discontinuation will be reported.

    Measured: Up to Week 104

  15. Number of Participants with Adverse Events (AEs)

    An adverse event is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.

    Measured: Up to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start15 May 2026
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion10 Nov 2028 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07582783
Sponsor's protocol ID
CNTO1959PSO4036
Acronym
PROGRESS-RO
Status last verified
Nov 2026
First submitted
6 May 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by Janssen Research & Development, LLC at 20 sites in Romania.

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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Romania. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Guselkumab Discontinuation Throughout 2 Years (time frame: Up to 2 years). 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 3 Nov 2026.

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