Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372108
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Brief Summary:
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).

Condition or disease Intervention/treatment
Crohn Disease Drug: Ustekinumab Drug: Other Biologic Therapies

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1536 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : August 31, 2029
Estimated Study Completion Date : August 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Group/Cohort Intervention/treatment
Ustekinumab New User Cohort
Participants with crohn's disease (CD) with no prior exposure to ustekinumab, at least 1 year of enrollment records immediately prior to the new use will be required. The information will be sourced from the Department of Defense (DoD) Electronic Health Records (EHR) database in the United States (US).
Drug: Ustekinumab
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 Biologics Comparator Cohort
Participants with CD with no prior exposure to the individual drugs (for example, infliximab, adalimumab, or vedolizumab) in question, at least 1 year of enrollment records immediately prior to the new use of the comparator biologic will be required. The information will be sourced from the Department of Defense (DoD) Electronic Health Records (EHR) database in the United States (US).
Drug: Other Biologic Therapies
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.




Primary Outcome Measures :
  1. Incidence Rate for Malignancy [ Time Frame: Up to 12 years ]
    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.


Secondary Outcome Measures :
  1. Opportunistic Infection (OI) [ Time Frame: Up to 12 years ]
    The OI will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time.

  2. Serious Infection [ Time Frame: Up to 12 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will include participants with Crohn's Disease (CD) 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.
Criteria

Inclusion Criteria:

  • Adult men and women with CD 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

Exclusion Criteria:

  • Participants below 18 years of age on the exposure index date
  • Participants who do not meet the definition for CD 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
  • In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372108


Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Layout table for location information
United States, Virginia
NMCP Recruiting
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
Layout table for additonal information
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT04372108    
Other Study ID Numbers: CR108561
RRA-18896 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents