Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04780516
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2021-03-01
Brief Title:
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
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
prIMMa
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None