Clinical trial NCT04780516: Study to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Psoriasis Treated With Subcutaneous Risankizumab Injection According to Standard of Care
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Keywords: Psoriasis
Risankizumab
Skyrizi
prIMMa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderate to severe psoriasis who are prescribed risankizumab according to local label prior to enrolling in this study.

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participants participating in a concurrent clinical interventional study or within 30 days.
* Participants treated with risankizumab prior to baseline visit.

Primary outcomes:
measure: Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
timeFrame: Up to approximately 104 weeks
measure: Change From Baseline in Average Nightly Nocturnal Scratch Activity
timeFrame: Baseline (Week 0) to Week 52
measure: Percentage of Participants With Physician Assessment Static Psoriasis Global Assessment (sPGA) 0 or 1
timeFrame: Up to approximately 104 weeks
measure: Change From Baseline in Average Pruritus Numeric Rating Scale (PNRS)
timeFrame: Up to approximately 4 weeks
measure: Change From Baseline in Medical Outcome Study Sleep Scale (MOS-SS)
timeFrame: Up to approximately 4 weeks
measure: Change From Baseline in Psoriasis Symptoms Scale (PSS)
timeFrame: Up to approximately 104 weeks
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Up to approximately 104 weeks
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI)
timeFrame: Up to approximately 104 weeks
measure: Percentage of Participants With Change From Baseline DLQI > Minimal Clinically Important Difference (MCID)
timeFrame: Up to approximately 104 weeks
measure: Percentage of Participants With Durability of Response Among sPGA Responders ar Week 24
timeFrame: Up to approximately 104 weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 104 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 251040
state: H_efa
city: Haifa
country: Israel
facility: Maccabi /ID# 246679
state: H_efa
city: Ashkelon
country: Israel
facility: Barzilai Medical Center /ID# 229156
state: HaDarom
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 226570
state: HaDarom
city: Rehovot
country: Israel
facility: Duplicate_Kaplan Medical Center /ID# 226569
state: HaMerkaz
city: Rehovot
country: Israel
facility: Leumit /ID# 252029
state: HaMerkaz
city: Safed
country: Israel
facility: ZIV Medical Center /ID# 226565
state: HaTsafon
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 226562
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 226564
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 247319
state: Yerushalayim
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 226568
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: