Crohn DiseaseRemiTRACNCT00723905
Remicade Infusion Management Program
An observational study of Crohn Disease and Arthritis, Rheumatoid, run by Janssen Inc. at 2 sites in Canada.
Trial summary
Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease, Arthritis, Rheumatoid
- How many people
- 1,630 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2005to Oct 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn's Disease with infliximab.
Who may be able to join
- Subject is a good candidate to receive infliximab as per the Product Monograph
- Subject is prescribed infliximab by an appropriate physician
- Subject receives infusion in a community infusion centre.
- Subject has signed the approved consent form.
Who cannot join
- Not specified in the protocol
Trial locations and contacts
2 sites in 1 country.
About this study
Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.
- Conditions
- Crohn Disease, Arthritis, Rheumatoid
- Keywords
- Crohn's Disease, Rheumatoid Arthritis
- Medical subject headings
- Crohn Disease, Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and frequency of infusion reactions
Measured: Up to 7 years
Pre-infusion treatments and efficacy
Measured: Up to 7 years
Infusion reaction management approaches
Measured: Up to 7 years
The number of subjects with adverse events
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- 1,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Inc. Clinical Trial, Study director, Janssen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723905
- Sponsor's protocol ID
- CR100746
- Other IDs
- P04466
- Acronym
- RemiTRAC
- Status last verified
- Jan 2013
- First submitted
- 25 Jul 2008
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Choquette D, Faraawi R, Chow A, Rodrigues J, Bensen WJ, Nantel F. Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry. J Rheumatol. 2015 Jul;42(7):1105-11. doi: 10.3899/jrheum.140538. Epub 2015 Jun 15.
PubMed 26077415
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remicade Infusion Management Program
- ClinicalTrials.gov ID
- NCT00723905
- Acronym / sponsor ID
- RemiTRAC / CR100746
- Conditions
- Crohn Disease, Arthritis, Rheumatoid
- Keywords
- Crohn's Disease, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,630 participants (actual)
- Lead sponsor
- Janssen Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 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.
Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn's Disease with infliximab.
Key inclusion criteria (4 listed)
- Subject is a good candidate to receive infliximab as per the Product Monograph
- Subject is prescribed infliximab by an appropriate physician
- Subject receives infusion in a community infusion centre.
- Subject has signed the approved consent form.
Key exclusion criteria (1 listed)
- Not specified in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type and frequency of infusion reactions
Time frame: Up to 7 years
Pre-infusion treatments and efficacy
Time frame: Up to 7 years
Infusion reaction management approaches
Time frame: Up to 7 years
The number of subjects with adverse events
Time frame: Up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Derived from this study: PubMed 26077415Choquette D, Faraawi R, Chow A, Rodrigues J, Bensen WJ, Nantel F. Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry. J Rheumatol. 2015 Jul;42(7):1105-11. doi: 10.3899/jrheum.140538. Epub 2015 Jun 15.
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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.
Janssen Inc. Clinical Trial study director
Janssen Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Arthritis, Rheumatoid, run by Janssen Inc. at 2 sites in Canada.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Type and frequency of infusion reactions (time frame: Up to 7 years). The study lists 4 primary outcomes in all. 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 NCT00723905, which also lists 1 linked publication.
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 15 Jan 2013.