CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring (INFORM)

May 31, 2024 updated by: Biogen

INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

The primary objective of the study is to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse event (SAE) in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective of this study in this study population is to evaluate disease severity over time in participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index (HBI).

Study Overview

Status

Terminated

Conditions

Crohn's Disease

Intervention / Treatment

Drug: natalizumab

Detailed Description

This study was originally conducted by Elan Pharmaceuticals, Inc. (Elan) in collaboration with Biogen under a protocol written by Elan. Biogen is solely responsible for the study since April 2013.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - San Juan, Puerto Rico, 00935
    - Research Site
United States
- Arizona
  - Scottsdale, Arizona, United States, 85260
    - Research Site
- California
  - Oceanside, California, United States, 92056
    - Research Site
  - San Francisco, California, United States, 94115
    - Research Site
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - Research Site
  - Hartford, Connecticut, United States, 06106
    - Research Site
- Florida
  - Gainesville, Florida, United States, 32610
    - Research Site
  - Miami, Florida, United States, 33136
    - Research Site
  - Winter Park, Florida, United States, 32789
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Research Site
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Research Site
  - Lexington, Kentucky, United States, 40536
    - Research Site
  - Louisville, Kentucky, United States, 40202
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Research Site
  - Boston, Massachusetts, United States, 02215
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Research Site
- Minnesota
  - Plymouth, Minnesota, United States, 55446
    - Research Site
- Missouri
  - Columbia, Missouri, United States, 65201
    - Research Site
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Research Site
- New Jersey
  - Egg Harbor Township, New Jersey, United States, 08234
    - Research Site
- New York
  - Great Neck, New York, United States, 11021
    - Research Site
  - Lake Success, New York, United States, 11042
    - Research Site
  - New York, New York, United States, 10021
    - Research Site
  - Rochester, New York, United States, 55905
    - Research Site
  - Troy, New York, United States, 48084
    - Research Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - Research Site
  - Charlotte, North Carolina, United States, 28207
    - Research Site
  - Raleigh, North Carolina, United States, 27607
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Research Site
  - Cleveland, Ohio, United States, 44195
    - Research Site
- Rhode Island
  - Providence, Rhode Island, United States, 02904
    - Research Site
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Research Site
- Texas
  - Grapevine, Texas, United States, 76051
    - Research Site
  - Houston, Texas, United States, 77030
    - Research Site
- Washington
  - Tacoma, Washington, United States, 98405
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants with CD who were naïve to natalizumab treatment and participants with CD who have been previously treated with natalizumab.

Description

Key Inclusion Criteria:

Subjects with Crohn's Disease (CD) who are eligible for therapy according to US Tysabri label and who are enrolled in the Tysabri Outreach Unified Commitment to Health (TOUCH) Prescribing Program.

Key Exclusion criteria:

None

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab Time Frame: Every 6 months for up to 5 years following the first Tysabri infusion	Every 6 months for up to 5 years following the first Tysabri infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of disease severity over time as assessed by change in HBI Time Frame: Every 6 months for up to 5 years following the first Tysabri infusion	Every 6 months for up to 5 years following the first Tysabri infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2008

Primary Completion (Actual)

May 28, 2015

Study Completion (Actual)