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.
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
- 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
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 group | Role | What they receive |
|---|---|---|
| Group 1: Participants with Moderate-to-Severe Plaque Psoriasis | Participants 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.
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)
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
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
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
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
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
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
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
Participant Baseline Characteristics: Age
Participant's age at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Participant Baseline Characteristics: Gender
Gender (male, female) of participants at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Participant Baseline Characteristics: Height
Height of participants at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Participant Baseline Characteristics: Weight
Weight of participants at the time of starting guselkumab treatment will be reported.
Measured: Baseline
Number of Participants Reporting Disease Severity
Number of participants with disease severity will be reported.
Measured: Baseline
Number of Participants Reporting Smoking History and Alcohol Use
Number of participants reporting smoking history and alcohol use will be reported.
Measured: Baseline
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
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.
- First posted13 May 2026
- Study start15 May 2026
- Primary completion15 Sep 2028 (estimated)
- Study completion10 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Romania SRL Clinical Trial, Study director, Johnson & Johnson Romania SRL
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07582783
- Acronym / sponsor ID
- PROGRESS-RO / CNTO1959PSO4036
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 10 Nov 2028 (estimated)
- First posted
- 13 May 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants with Moderate-to-Severe Plaque Psoriasis | – | –Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
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.
15 secondary outcomes
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 PASI 90 Response Score
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving PASI 75 Response Score
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving PASI 100 Response Score
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving IGA Score of 0
Time frame: At Weeks 0, 12, 24, 52 and 104
Participant Baseline Characteristics: Age
Time frame: Baseline
Participant Baseline Characteristics: Gender
Time frame: Baseline
Participant Baseline Characteristics: Height
Time frame: Baseline
Participant Baseline Characteristics: Weight
Time frame: Baseline
Number of Participants Reporting Disease Severity
Time frame: Baseline
Number of Participants Reporting Smoking History and Alcohol Use
Time frame: Baseline
Hazard Ratio Between Baseline Factors and Time to Guselkumab Treatment Discontinuation
Time frame: Up to Week 104
Number of Participants with Adverse Events (AEs)
Time frame: Up to Week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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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.
Johnson & Johnson Romania SRL Clinical Trial study director
Johnson & Johnson Romania SRL
20 sites in 1 country: see every site and its status.
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.