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A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

ConditionsCrohn DiseaseColitis, Ulcerative
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Scientific Affairs, LLC

About this trial

The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period

Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs

Disqualifiers

Participants below 18 years of age on the exposure index date

Participants who do not meet the definition for CD or UC prior to or on the exposure index date

Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer [NMSC]) at any time prior to or on the exposure index date

Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date

Trial population

The study population will include participants with Crohn's Disease (CD) or Ulcerative Colitis (UC) who are new users of ustekinumab and new users of the comparator drugs which will be identified from the Department of Defense (DoD) Electronic Health Records (EHR) database.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Ustekinumab

    Drug

    Participants who are new users of ustekunumab will be included in the cohort. No study treatment will be administered as a part of this study.

  • Other Biologic Therapies

    Drug

    Participants who are new users of other biologic therapies (for examples for example, infliximab, adalimumab, or vedolizumab administered as per the prescription record) will be included in this cohort. No study treatment will be administered as a part of this study.

Treatment groups

1,536 Participants
are divided into 2 treatment groups
Group A: Ustekinumab New User Cohort1 intervention
Group B: Other Biologics Comparator Cohort1 intervention

Trial outcomes

Primary outcomes

1

Incidence Rate for Malignancy

The incidence rates for malignancy (including Non-melanoma skin cancer \[NMSC\]) will be estimated as the number of incident cases (that is, counts of unique participants) divided by the total at-risk time.

Time frame
Up to 10 years and 3 months

Secondary outcomes

1

Opportunistic Infection (OI)

The OI will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time.

Time frame
Up to 10 years and 3 months
2

Serious Infection

The serious infections will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time.

Time frame
Up to 10 years and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Scientific Affairs, LLC

Lead sponsor

Source ClinicalTrials.gov
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