Crohn's DiseaseINFORMNCT00707512
CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
An observational study of Crohn's Disease, run by Biogen at 36 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- natalizumab
- How many people
- 87 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 30 Jun 2008to 28 May 2015
- 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: Participants with CD who were naïve to natalizumab treatment and participants with CD who have been previously treated with natalizumab.
Who may be able to join
- 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.
Who cannot join
- None
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States35 sites
Research site
Ann Arbor, Michigan, 48109
Research site
Atlanta, Georgia, 30342
Research site
Baltimore, Maryland, 21201
Research site
Boston, Massachusetts, 02114
Research site
Boston, Massachusetts, 02215
Research site
Chapel Hill, North Carolina, 27599
Research site
Charlotte, North Carolina, 28207
Research site
Cincinnati, Ohio, 45219
Research site
Cleveland, Ohio, 44195
Research site
Columbia, Missouri, 65201
Research site
Crestview Hills, Kentucky, 41017
Research site
Egg Harbor, New Jersey, 08234
Research site
Gainesville, Florida, 32610
Research site
Grapevine, Texas, 76051
Research site
Great Neck, New York, 11021
Research site
Hamden, Connecticut, 06518
Research site
Hartford, Connecticut, 06106
Research site
Houston, Texas, 77030
Research site
Lake Success, New York, 11042
Research site
Lebanon, New Hampshire, 03756
Research site
Lexington, Kentucky, 40536
Research site
Louisville, Kentucky, 40202
Research site
Miami, Florida, 33136
Research site
Nashville, Tennessee, 37232
Research site
New York, New York, 10021
Research site
Oceanside, California, 92056
Research site
Plymouth, Minnesota, 55446
Research site
Providence, Rhode Island, 02904
Research site
Raleigh, North Carolina, 27607
Research site
Rochester, New York, 55905
Research site
San Francisco, California, 94115
Research site
Scottsdale, Arizona, 85260
Research site
Tacoma, Washington, 98405
Research site
Troy, New York, 48084
Research site
Winter Park, Florida, 32789
About this study
Official title: 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).
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- natalizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natalizumabDrug
Also called Tysabri, BG00002
Administered as specified in the TOUCH Prescribing Program
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab
Measured: Every 6 months for up to 5 years following the first Tysabri infusion
Secondary outcomes (1)
Measurement of disease severity over time as assessed by change in HBI
Measured: Every 6 months for up to 5 years following the first Tysabri infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study start30 Jun 2008
- Primary completion28 May 2015
- Study completion28 May 2015
Why it stopped: Sponsor's decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707512
- Sponsor's protocol ID
- 101CD401
- Other IDs
- ELN100226-CD451
- Acronym
- INFORM
- Status last verified
- May 2024
- First submitted
- 27 Jun 2008
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
- ClinicalTrials.gov ID
- NCT00707512
- Acronym / sponsor ID
- INFORM / 101CD401
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor's decision.
- Enrolment
- 87 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2008 (actual)
- Primary completion
- 28 May 2015 (actual)
- Study completion
- 28 May 2015 (actual)
- First posted
- 1 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with CD who were naïve to natalizumab treatment and participants with CD who have been previously treated with natalizumab.
Key inclusion criteria (1 listed)
- 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 (2 listed)
- None
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natalizumabAlso: Tysabri, BG00002Administered as specified in the TOUCH Prescribing Program | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Sponsor's decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Biogen at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: stopped early, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Sponsor's decision.). Results are not available in the source record.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2024.