Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting
Study Purpose
Psoriasis is a common, chronic, inflammatory disorder which primarily affects the skin and joints and is associated with impairment of quality of life. The main objective of this study is to assess how safe risankizumab is compared to other therapies in treating adult participants with psoriasis in real world setting in the United States. Adverse events will be assessed using secondary sources. Skyrizi (Risankizumab) is an approved drug for the treatment of moderate to severe psoriasis in the United States. Participants who are prescribed risankizumab or other comparator drugs in the real world setting will be included in this study. Data from approximately 3000 risankizumab new users and 12000 other comparator new users across the United States will be evaluated. Participants will receive subcutaneous risankizumab injection or other comparative drugs as prescribed by their physician. Data from these participants will be collected for approximately 10 years. There will be no additional burden for participants in this study compared to their standard of care as secondary data sources will be used.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04799990 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AbbVie |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
ABBVIE INC. |
| Principal Investigator Affiliation | AbbVie |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
| Overall Status | Recruiting |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriasis |
| Study Website: | View Trial Website |
Contact a Trial Team
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