Prospective Non-Interventional Study to Investigate the Durable Effectiveness of Risankizumab Using Digital and Remote Evaluation Tools in Moderate to Severe Psoriasis Patients - prIMMa Study

Status: Active_not_recruiting
Location: See all (11) locations...
Study Type: Observational
SUMMARY

Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis. Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel. Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical diagnosis of moderate to severe psoriasis.

• Prescribed risankizumab as the standard treatment for psoriasis, according to the local label. The decision to prescribe risankizumab will be made solely by the physician, based on his clinical judgment, and is done prior to any decision to approach the participant to participate in this study.

• Willing to be involved in the study, to sign an informed consent form and complete study questionnaires.

• Participants participating in digital component: Pruritus Numeric Rating Scale (PNRS) score \>=4 at baseline.

Locations
Other Locations
Israel
HaEmek Medical Center /ID# 251040
Afula
Barzilai Medical Center /ID# 229156
Ashkelon
Soroka University Medical Center /ID# 226570
Beersheba
Maccabi /ID# 246679
Haifa
Shaare Zedek Medical Center /ID# 247319
Jerusalem
Rabin Medical Center /ID# 226568
Petah Tikva
The Chaim Sheba Medical Center /ID# 226562
Ramat Gan
Duplicate_Kaplan Medical Center /ID# 226569
Rehovot
Leumit /ID# 252029
Rehovot
ZIV Medical Center /ID# 226565
Safed
Tel Aviv Sourasky Medical Center /ID# 226564
Tel Aviv
Time Frame
Start Date: 2021-04-26
Completion Date: 2026-12
Participants
Target number of participants: 141
Treatments
Participants Treated With Risankizumab
Participants will receive risankizumab (Skyrizi) as prescribed by the physician according to the local label.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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