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PsoriasisNCT04799990

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

An observational study of Psoriasis, run by AbbVie.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Study is not recruiting and using secondary data sources only Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Risankizumab, Comparator 1 and Comparator 2
How many people
0 participants
Where
No sites listed yet
Study dates
23 Jun 2021to 10 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study is not recruiting and using secondary data sources only

Study is not recruiting and using secondary data sources only

About this study

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

Study is not recruiting and using secondary data sources only

Read the detailed description

Study is not recruiting and using secondary data sources only

Conditions
Psoriasis
Being tested
Risankizumab, Comparator 1, Comparator 2
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisankizumabDrug

    Also called Skyrizi

    Subcutaneous Injection

  • Comparator 1Biological

    Subcutaneous or Intravenous Injection

  • Comparator 2Drug

    Oral, Opthalmic, Subcutaneous or Intravenous Injection

Study groups in NCT04799990
Study groupRoleWhat they receive
RisankizumabParticipants will receive risankizumab as prescribed by their physician.
Receives: Drug: Risankizumab
Comparator Group 1Participants will receive biologics other than interleukin (IL)-23 antagonists as prescribed by their physician.
Receives: Biological: Comparator 1
Comparator Group 2Participants will receive non-biologic systemic small molecules as prescribed by their physician.
Receives: Drug: Comparator 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to approximately 10 years

Secondary outcomes (8)

  1. 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.

    Measured: Up to approximately 10 years

  2. 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.

    Measured: Up to approximately 10 years

  3. 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.

    Measured: Up to approximately 10 years

  4. 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.

    Measured: Up to approximately 10 years

  5. Incidence Rate of Participants With Autoimmune Disease

    Autoimmune disease is defined as outpatient or inpatient encounter for systemic lupus erythematosus (SLE).

    Measured: Up to approximately 10 years

  6. 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.

    Measured: Up to approximately 10 years

  7. 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.

    Measured: Up to approximately 10 years

  8. 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).

    Measured: Up to approximately 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start23 Jun 2021
  3. Primary completion10 Mar 2022
  4. Study completion10 Mar 2022

Why it stopped: Study is not recruiting and using secondary data sources only

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799990
Sponsor's protocol ID
P16-772
Status last verified
Dec 2022
First submitted
15 Mar 2021
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Participants With Major Adverse Cardiovascular Events (MACE) (time frame: Up to approximately 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.

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