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

NCT00755937 | Terminated Results

• 1 other identifier: P02793
• Study Type: observational
• Target: 556
• Locations: 0 countries
• Sites: N/A

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®.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  36 months after baseline

Secondary Outcomes (1)

• Number of Serious Adverse Events

  Throughout study (up to 36 months)

Study Arms (1)

Subjects receiving Remicade

Crohn's disease subjects receiving Remicade® per Product Monograph.

Other: Data collection post infusion

Interventions

Data collection post infusion OTHER

Subjects receiving Remicade

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primarily from community centers and some academic centers.

You may qualify if:

• 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.

You may not qualify if:

• Per product monograph

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: September 19, 2008
• Study Start: February 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 22, 2015
• Results First Posted: June 11, 2009

Record last verified: 2015-05