Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting

Psoriasis Clinical Trial

Official title:

Post-Marketing Real World Safety Study of Risankizumab in the United States

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04799990
• Other study ID #: P16-772
• Status: Withdrawn
• Start date: June 23, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: December 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study is not recruiting and using secondary data sources only

Description:

Study is not recruiting and using secondary data sources only

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older
• Eligibility: Study is not recruiting and using secondary data sources only

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Risankizumab
Subcutaneous Injection

Biological:
• Comparator 1
Subcutaneous or Intravenous Injection

Drug:
• Comparator 2
Oral, Opthalmic, Subcutaneous or Intravenous Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Participants With Major Adverse Cardiovascular Events (MACE)	MACE is defined as any fatal or nonfatal myocardial infarction (MI) or stroke (including cerebral infarction, nontraumatic intracerebral hemorrhage, and nontraumatic subarachnoid hemorrhage).	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Serious Infections	Serious infections is defined as inpatient encounter for infections or receiving treatment with intravenous antibiotics, anti-viral or anti-fungal medications.	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Tuberculosis	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.	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Opportunistic Infections Excluding Tuberculosis and Herpes Zoster	Opportunistic infections are defined as outpatient or inpatient encounter for opportunistic infections excluding tuberculosis and herpes zoster.	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Serious Hypersensitivity Reactions	Serious hypersensitivity reactions are defined as emergency department (ED) or inpatient encounter for serious hypersensitivity reactions including anaphylaxis.	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Autoimmune Disease	Autoimmune disease is defined as outpatient or inpatient encounter for systemic lupus erythematosus (SLE).	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Neurologic or Demyelinating Disease	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.	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Gastrointestinal Adverse Events	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.	Up to approximately 10 years
Secondary	Incidence Rate of Participants With Nonmalignant-Hematologic Adverse Events	Nonmalignant-hematologic adverse events are defined as outpatient or inpatient encounter for a non-malignant hematological adverse events (pancytopenia, agranulocytosis and aplastic anemia).	Up to approximately 10 years