Anti Inflammatory Diet With Physical Therapy on Psoriasis
NCT07736651
Inflammation, Pathologic Processes
Giza, Ad Doki, Egypt
View Trial DetailsNCT Number: NCT07582783
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Qualimed SRL, Brasov, Romania
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline
Participant's age at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Gender (male, female) of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Height of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Weight of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Number of participants with disease severity will be reported.
Time frame: Baseline
Number of participants reporting smoking history and alcohol use will be reported.
Time frame: Up to Week 104
Hazard Ratio Between Baseline Factors and time to Guselkumab treatment discontinuation will be reported.
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.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
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
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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