Trial Outcomes & Findings for Remicade® Crohn's Disease Registry Across Canada (Study P02793) (NCT NCT00755937)

Last Updated: 2015-06-22

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

556 participants

Primary outcome timeframe

12 months after baseline

Results posted on

2015-06-22

Participant Flow

This was an observational trial/registry. Recruitment began in 2002. Subjects were drawn 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.

Participant milestones

Participant milestones
Measure	Subjects Receiving Remicade Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Recruitment STARTED	556
Recruitment COMPLETED	392
Recruitment NOT COMPLETED	164
Observational Follow-up STARTED	392
Observational Follow-up COMPLETED	244
Observational Follow-up NOT COMPLETED	148

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Receiving Remicade Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Recruitment Unknown if infliximab received	164
Observational Follow-up Lost to Follow-up	148

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Receiving Remicade n=556 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Age, Continuous	37.5 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	314 Participants n=5 Participants
Sex: Female, Male Male	242 Participants n=5 Participants
Region of Enrollment Canada	556 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after baseline

Population: 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.

Outcome measures

Outcome measures
Measure	Subjects Receiving Remicade n=179 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).	118 Participants

PRIMARY outcome

Timeframe: 24 months after baseline

Population: 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.

Outcome measures

Outcome measures
Measure	Subjects Receiving Remicade n=91 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).	66 Participants

PRIMARY outcome

Timeframe: 36 months after baseline

Population: 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.

Outcome measures

Outcome measures
Measure	Subjects Receiving Remicade n=43 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).	31 Participants

PRIMARY outcome

Timeframe: 12 months after baseline

Outcome measures

Outcome measures
Measure	Subjects Receiving Remicade n=179 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Clinical Remission at 12 Months (CDAI <= 150 Points).	108 Participants

PRIMARY outcome

Timeframe: 24 months after baseline

Outcome measures

Outcome measures
Measure	Subjects Receiving Remicade n=91 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Clinical Remission at 24 Months (CDAI <= 150 Points).	59 Participants

PRIMARY outcome

Timeframe: 36 months after baseline

Outcome measures

Outcome measures
Measure	Subjects Receiving Remicade n=43 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Clinical Remission at 36 Months (CDAI <= 150 Points).	31 Participants

SECONDARY outcome

Timeframe: Throughout study (up to 36 months)

Population: Safety data were collected for all patients registered. Total number of subjects: 556. Non serious adverse events: 198. Serious Adverse Events: 105.

Outcome measures

Outcome measures
Measure	Subjects Receiving Remicade n=556 Participants Crohn's disease subjects who were to receive Remicade® per Product Monograph.
Number of Serious Adverse Events	105 Number of Serious Adverse Events

Adverse Events

Subjects Receiving Remicade

Serious events: 39 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subjects Receiving Remicade n=392 participants at risk
Cardiac disorders PALPITATIONS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Eye disorders EYE OEDEMA	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Eye disorders RETINAL DISORDER	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders ABDOMINAL PAIN	0.51% 2/392 • Number of events 3 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders APPENDICITIS PERFORATED	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders CROHN'S DISEASE	2.6% 10/392 • Number of events 11 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders DIARRHOEA	0.26% 1/392 • Number of events 2 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders FAECALOMA	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders ILEAL STENOSIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders INTESTINAL STENOSIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders PERITONITIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.77% 3/392 • Number of events 3 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Gastrointestinal disorders VOMITING	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders CHEST PAIN	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders DEATH	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders DRUG INEFFECTIVE	0.51% 2/392 • Number of events 2 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders FATIGUE	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders INFLUENZA LIKE ILLNESS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders INFUSION RELATED REACTION	0.51% 2/392 • Number of events 2 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders PYREXIA	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
General disorders THERAPEUTIC RESPONSE DECREASED	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Immune system disorders ANAPHYLACTIC REACTION	0.51% 2/392 • Number of events 2 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations ABDOMINAL ABSCESS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations BRAIN ABSCESS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations BRONCHITIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations CELLULITIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations ESCHERICHIA SEPSIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations MENINGITIS VIRAL	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations PERIANAL ABSCESS	0.51% 2/392 • Number of events 2 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations RECTAL ABSCESS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations SUBCUTANEOUS ABSCESS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Infections and infestations TOOTH ABSCESS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Injury, poisoning and procedural complications ANASTOMOTIC STENOSIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Injury, poisoning and procedural complications DRUG EXPOSURE DURING PREGNANCY	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Metabolism and nutrition disorders DEHYDRATION	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Musculoskeletal and connective tissue disorders MYALGIA	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Psychiatric disorders MENTAL DISORDER	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Renal and urinary disorders NEPHROLITHIASIS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Skin and subcutaneous tissue disorders BLISTER	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Surgical and medical procedures PROCTOCOLECTOMY	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.
Surgical and medical procedures SURGERY	0.26% 1/392 • Number of events 1 Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population) were included in this analyses.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place