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NCT Number: NCT07582783

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qualimed SRL, Brasov, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Time to Guselkumab Discontinuation Throughout 2 Years

    Time frame: Up to 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.

Secondary outcomes

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

    Time frame: At Weeks 12, 24, 52 and 104

    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.

  2. Percentage of Participants Achieving PASI 90 Response Score

    Time frame: At Weeks 0, 12, 24, 52 and 104

    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.

  3. Percentage of Participants Achieving PASI 75 Response Score

    Time frame: At Weeks 0, 12, 24, 52 and 104

    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.

  4. Percentage of Participants Achieving PASI 100 Response Score

    Time frame: At Weeks 0, 12, 24, 52 and 104

    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.

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

    Time frame: At Weeks 0, 12, 24, 52 and 104

    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.

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

    Time frame: At Weeks 0, 12, 24, 52 and 104

    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.

  7. Percentage of Participants Achieving IGA Score of 0

    Time frame: At Weeks 0, 12, 24, 52 and 104

    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.

  8. Participant Baseline Characteristics: Age

    Time frame: Baseline

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

  9. Participant Baseline Characteristics: Gender

    Time frame: Baseline

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

  10. Participant Baseline Characteristics: Height

    Time frame: Baseline

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

  11. Participant Baseline Characteristics: Weight

    Time frame: Baseline

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

  12. Number of Participants Reporting Disease Severity

    Time frame: Baseline

    Number of participants with disease severity will be reported.

  13. Number of Participants Reporting Smoking History and Alcohol Use

    Time frame: Baseline

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

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

    Time frame: Up to Week 104

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

  15. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Week 104

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: PROGRESS-RO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 13, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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