Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT04799990
- Lead Sponsor
- AbbVie
- Brief Summary
Study is not recruiting and using secondary data sources only
- Detailed Description
Study is not recruiting and using secondary data sources only
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Comparator Group 2 Comparator 2 Participants will receive non-biologic systemic small molecules as prescribed by their physician. Comparator Group 1 Comparator 1 Participants will receive biologics other than interleukin (IL)-23 antagonists as prescribed by their physician. Risankizumab Risankizumab Participants will receive risankizumab as prescribed by their physician.
- Primary Outcome Measures
Name Time Method Incidence Rate of Participants With Major Adverse Cardiovascular Events (MACE) Up to approximately 10 years MACE is defined as any fatal or nonfatal myocardial infarction (MI) or stroke (including cerebral infarction, nontraumatic intracerebral hemorrhage, and nontraumatic subarachnoid hemorrhage).
- Secondary Outcome Measures
Name Time Method Incidence Rate of Participants With Neurologic or Demyelinating Disease Up to approximately 10 years Neurologic or demyelinating disease is defined as outpatient or inpatient encounter for multiple sclerosis (MS), optic neuritis, and the peripheral demyelinating disease Guillain-Barré syndrome.
Incidence Rate of Participants With Serious Infections Up to approximately 10 years Serious infections is defined as inpatient encounter for infections or receiving treatment with intravenous antibiotics, anti-viral or anti-fungal medications.
Incidence Rate of Participants With Tuberculosis Up to approximately 10 years Tuberculosis is defined as inpatient encounter for active tuberculosis, or outpatient encounter with a dispensing of at least two classes of first-line anti-tuberculosis medications (e.g., isoniazid, rifampin, pyrazinamide, or ethambutol) for a sufficient duration to differentiate prophylaxis and treatment use.
Incidence Rate of Participants With Autoimmune Disease Up to approximately 10 years Autoimmune disease is defined as outpatient or inpatient encounter for systemic lupus erythematosus (SLE).
Incidence Rate of Participants With Gastrointestinal Adverse Events Up to approximately 10 years Gastrointestinal adverse events are defined as inpatient encounter for gastrointestinal perforation. Gastrointestinal (GI) perforation is defined as perforation of the esophagus, stomach, small intestine, large intestine, and unspecified lower GI.
Incidence Rate of Participants With Serious Hypersensitivity Reactions Up to approximately 10 years Serious hypersensitivity reactions are defined as emergency department (ED) or inpatient encounter for serious hypersensitivity reactions including anaphylaxis.
Incidence Rate of Participants With Nonmalignant-Hematologic Adverse Events Up to approximately 10 years Nonmalignant-hematologic adverse events are defined as outpatient or inpatient encounter for a non-malignant hematological adverse events (pancytopenia, agranulocytosis and aplastic anemia).
Incidence Rate of Participants With Opportunistic Infections Excluding Tuberculosis and Herpes Zoster Up to approximately 10 years Opportunistic infections are defined as outpatient or inpatient encounter for opportunistic infections excluding tuberculosis and herpes zoster.