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Satisfied a post-marketing commitment to Canadian Health Authorities.
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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®.
Subjects will be selected for this registry using a non-probability sampling method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving Remicade | Crohn's disease subjects receiving Remicade® per Product Monograph. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection post infusion | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events | Throughout study (up to 36 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Primarily from community centers and some academic centers.
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.
This was an observational trial/registry. Recruitment began in 2002. Subjects were drawn from community centers and some academic centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Receiving Remicade | Crohn's disease subjects who were to receive Remicade® per Product Monograph. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recruitment |
|
| ||||||||||||||||||
| Observational Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Receiving Remicade | Crohn's disease subjects who were to receive Remicade® per Product Monograph. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Participants | 12 months after baseline |
|
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Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Receiving Remicade |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PALPITATIONS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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 |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | 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. | Posted | Number | Participants | 24 months after baseline |
|
|
|
|
| Primary | 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. | 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. | Posted | Number | Participants | 36 months after baseline |
|
|
|
|
| Primary | 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. | 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. | Posted | Number | Participants | 12 months after baseline |
|
|
|
|
| Primary | 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. | 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. | Posted | Number | Participants | 24 months after baseline |
|
|
|
|
| Primary | 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. | 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. | Posted | Number | Participants | 36 months after baseline |
|
|
|
|
| Secondary | Number of Serious Adverse Events | Safety data were collected for all patients registered. Total number of subjects: 556. Non serious adverse events: 198. Serious Adverse Events: 105. | Posted | Number | Number of Serious Adverse Events | Throughout study (up to 36 months) |
|
|
|
| 39 |
| 392 |
| 0 |
| 392 |
| EYE OEDEMA | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| RETINAL DISORDER | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| APPENDICITIS PERFORATED | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| FAECALOMA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| ILEAL STENOSIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PERITONITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 10.0 | Systematic Assessment |
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| DRUG INEFFECTIVE | General disorders | MedDRA 10.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 10.0 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 10.0 | Systematic Assessment |
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| INFUSION RELATED REACTION | General disorders | MedDRA 10.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment |
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| THERAPEUTIC RESPONSE DECREASED | General disorders | MedDRA 10.0 | Systematic Assessment |
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| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
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| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| BRAIN ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| MENINGITIS VIRAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| PERIANAL ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| RECTAL ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| TOOTH ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| ANASTOMOTIC STENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| DRUG EXPOSURE DURING PREGNANCY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| MENTAL DISORDER | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PROCTOCOLECTOMY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| SURGERY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
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| D007410 | Intestinal Diseases |