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

Conditions

Crohn's Disease

Brief summary

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®.

Detailed description

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

Related papers

No related papers found yet.

Interventions

OTHERData collection post infusion

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* 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.

Exclusion criteria

* Per product monograph

Design outcomes

Primary

Measure	Time frame	Description
Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).	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 Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).	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).	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).	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).	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).	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.

Secondary

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

Participant flow

Recruitment details

This was an observational trial/registry. Recruitment began in 2002. Subjects were drawn from community centers and some academic centers.

Pre-assignment details

Not applicable for an observational trial. Subjects were not assigned to treatment, but received infliximab only if their physician had decided to treat with infliximab.

Participants by arm

Arm	Count
Subjects Receiving Remicade Crohn's disease subjects who were to receive Remicade® per Product Monograph.	556
Total	556

Withdrawals & dropouts

Period	Reason	FG000
Observational Follow-up	Lost to Follow-up	148
Recruitment	Unknown if infliximab received	164

Baseline characteristics

Characteristic	Subjects Receiving Remicade
Age, Continuous	37.5 years STANDARD_DEVIATION 12.8
Region of Enrollment Canada	556 participants
Sex: Female, Male Female	314 Participants
Sex: Female, Male Male	242 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 392
serious Total, serious adverse events	39 / 392