Crohn's DiseaseRemiTRAC®NCT00755937

Remicade® Crohn's Disease Registry Across Canada (Study P02793)

An observational study of Crohn's Disease, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Crohn's Disease
What is being tested?: Data collection post infusion
Type of treatment: Injection or infusion
How many people: 556 participants
Where: No sites listed yet
Study dates: Feb 2002to Sep 2007
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Primarily from community centers and some academic centers.

Who may be able to join

Patient was given the Patient Information Brochure; AND,
Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
Patient is a good candidate to receive Remicade® as per the product monograph; AND,
Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
Patient has signed the approved consent form.

Who cannot join

Per product monograph

About this study

Official title: Remicade® Treatment Registry Across Canada in Crohn's Disease

This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment of Crohn's disease with Remicade®.

Read the detailed description

Subjects will be selected for this registry using a non-probability sampling method.

Conditions: Crohn's Disease
Being tested: Data collection post infusion
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Data collection post infusionOther

Study groups in NCT00755937
Study group	Role	What they receive
Subjects receiving Remicade		Crohn's disease subjects receiving Remicade® per Product Monograph. Receives: Other: Data collection post infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Measured: 12 months after baseline
Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Measured: 24 months after baseline
Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Measured: 36 months after baseline
Clinical Remission at 12 Months (CDAI <= 150 Points).
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Measured: 12 months after baseline
Clinical Remission at 24 Months (CDAI <= 150 Points).
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Measured: 24 months after baseline
Clinical Remission at 36 Months (CDAI <= 150 Points).
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Measured: 36 months after baseline

Secondary outcomes (1)

Number of Serious Adverse Events
Measured: Throughout study (up to 36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2002Sep 2007

First posted19 Sep 2008 (estimated)
Study startFeb 2002
Primary completionSep 2007
Study completionSep 2007

Why it stopped: Satisfied a post-marketing commitment to Canadian Health Authorities.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: 556 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00755937
Sponsor's protocol ID: P02793
Acronym: RemiTRAC®
Status last verified: May 2015
First submitted: 26 Aug 2008
Last updated: 22 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remicade® Treatment Registry Across Canada in Crohn's Disease
ClinicalTrials.gov ID: NCT00755937
Acronym / sponsor ID: RemiTRAC® / P02793
Conditions: Crohn's Disease
Study type: Observational
Recruitment status: TerminatedReason stopped: Satisfied a post-marketing commitment to Canadian Health Authorities.
Enrolment: 556 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Feb 2002
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 19 Sep 2008 (estimated)
Results: Posted 11 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects will be selected for this registry using a non-probability sampling method.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects receiving Remicade	–	Other: Data collection post infusionCrohn's disease subjects receiving Remicade® per Product Monograph.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Primarily from community centers and some academic centers.

Key inclusion criteria (5 listed)

Patient was given the Patient Information Brochure; AND,
Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
Patient is a good candidate to receive Remicade® as per the product monograph; AND,
Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
Patient has signed the approved consent form.

Key exclusion criteria (1 listed)

Per product monograph

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
Data collection post infusion	Other	Subjects receiving Remicade

Primary outcome

Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).
Time frame: 12 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
Time frame: 24 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
Time frame: 36 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 12 Months (CDAI <= 150 Points).
Time frame: 12 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 24 Months (CDAI <= 150 Points).
Time frame: 24 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 36 Months (CDAI <= 150 Points).
Time frame: 36 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.

1 secondary outcome

Number of Serious Adverse Events
Time frame: Throughout study (up to 36 months)

Results and safety

Results posted to the registry on 11 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Receiving Remicade	556	392

Primary outcome: Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).

Time frame: 12 months after baseline. Number. Unit: Participants

Measure	Subjects Receiving Remicade n = 179
Value	118

Subjects Receiving Remicade: Percentage (no inferential test): 66.3

Population analysed: Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.

Primary outcome: Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).

Time frame: 24 months after baseline. Number. Unit: Participants

Measure	Subjects Receiving Remicade n = 91
Value	66

Subjects Receiving Remicade: percentage (no inferential test): 72.5

Population analysed: Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.

Primary outcome: Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).

Time frame: 36 months after baseline. Number. Unit: Participants

Measure	Subjects Receiving Remicade n = 43
Value	31

Subjects Receiving Remicade: Percentage (no inferential test): 72.1

Population analysed: Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.

Primary outcome: Clinical Remission at 12 Months (CDAI <= 150 Points).

Time frame: 12 months after baseline. Number. Unit: Participants

Measure	Subjects Receiving Remicade n = 179
Value	108

Subjects Receiving Remicade: Percentage (no inferential test): 60.3

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Receiving Remicade	39 of 392 (9.9%)	0 of 392 (0%)	Not reported

Limitations and caveats (from the sponsor): This was an observational study. There were no imposed interventions from the Sponsor including imposing specific duration of treatment or data collection beyond the standard of care.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by Merck Sharp & Dohme LLC.

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 5 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: stopped early, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 11 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline). (time frame: 12 months after baseline). The study lists 6 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 NCT00755937.

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 22 Jun 2015.