Trial · NCT00705614

Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035)

NCT00705614, Completed, Merck Sharp & Dohme LLC; results first posted 2014-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035). Trials, record NCT00705614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00705614

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035)
NCT number: NCT00705614
Status: Completed
Enrollment: 2,662 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Crohn's Disease
Interventions: Remicade
First posted: 2008-06-26
Last updated: 2017-03-22
Results first posted: 2014-08-26

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Serious Infections	Up to 5 Years	The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii \[PCP\] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.
Primary	Number of Participants With Infusion-Related Reactions/Hypersensitivity	Up to 5 Years	The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.
Primary	Number of Participant Fatalities	Up to 5 Years	The number of participant fatalities was evaluated throughout the study.
Primary	Number of Participants With New or Worsening Congestive Heart Failure	Up to 5 Years	The number of participants with new or worsening congestive heart failure was evaluated throughout the study.
Primary	Number of Participants With Demyelinating Neurological Disorders	Up to 5 Years	The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.
Primary	Number of Participants With Hematologic Conditions	Up to 5 Years	The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.
Primary	Number of Participants With Lymphoproliferative Disorders/Malignancies	Up to 5 Years	The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.
Secondary	Participant Assessment of Overall Health Status By Study Visit	Up to 5 Years	The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.
Secondary	The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit	Up to 5 Years	The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.
Secondary	Work/Daily Activity Status Score By Study Visit	Up to 5 Years	The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Serious Infections	Up to 5 Years	The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Participants	NUMBER
PRIMARY	Number of Participants With Infusion-Related Reactions/Hypersensitivity	Up to 5 Years	The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Participants	NUMBER
PRIMARY	Number of Participant Fatalities	Up to 5 Years	The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Participants	NUMBER
PRIMARY	Number of Participants With New or Worsening Congestive Heart Failure	Up to 5 Years	The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Participants	NUMBER
PRIMARY	Number of Participants With Demyelinating Neurological Disorders	Up to 5 Years	The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Participants	NUMBER
PRIMARY	Number of Participants With Hematologic Conditions	Up to 5 Years	The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Participants	NUMBER
PRIMARY	Number of Participants With Lymphoproliferative Disorders/Malignancies	Up to 5 Years	The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Participants	NUMBER
SECONDARY	Participant Assessment of Overall Health Status By Study Visit	Up to 5 Years	The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Score on a Scale	MEAN
SECONDARY	The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit	Up to 5 Years	The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Score on a Scale	MEAN
SECONDARY	Work/Daily Activity Status Score By Study Visit	Up to 5 Years	The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.	Score on a Scale	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group252

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Serious Infections	Remicade	132	Participants
Number of Participants With Serious Infections	Standard Therapy	47	Participants
Number of Participants With Serious Infections	Switched to Remicade	18	Participants
Number of Participants With Infusion-Related Reactions/Hypersensitivity	Remicade	173	Participants
Number of Participants With Infusion-Related Reactions/Hypersensitivity	Standard Therapy	1	Participants
Number of Participants With Infusion-Related Reactions/Hypersensitivity	Switched to Remicade	28	Participants
Number of Participant Fatalities	Remicade	30	Participants
Number of Participant Fatalities	Standard Therapy	14	Participants
Number of Participant Fatalities	Switched to Remicade	4	Participants
Number of Participants With New or Worsening Congestive Heart Failure	Remicade	1	Participants

1 to 10 of 252Source ClinicalTrials.gov

See all 252 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Initial Intervention	STARTED	Remicade	1,541
Initial Intervention	STARTED	Standard Therapy Group	1,121
Initial Intervention	COMPLETED	Remicade	1,023
Initial Intervention	COMPLETED	Standard Therapy Group	800
Initial Intervention	NOT COMPLETED	Remicade	518
Initial Intervention	NOT COMPLETED	Standard Therapy Group	321
Switch to Remicade	STARTED	Remicade	0
Switch to Remicade	STARTED	Standard Therapy Group	298
Switch to Remicade	COMPLETED	Remicade	0
Switch to Remicade	COMPLETED	Standard Therapy Group	249

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events2,019

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ABDOMINAL PAIN	Gastrointestinal disorders	Standard Therapy	41	1,121	45
other	ABDOMINAL PAIN	Gastrointestinal disorders	Remicade	100	1,541	124
other	ABDOMINAL PAIN	Gastrointestinal disorders	Switched to Remicade	15	298	18
other	CROHN'S DISEASE	Gastrointestinal disorders	Standard Therapy	64	1,121	84
other	CROHN'S DISEASE	Gastrointestinal disorders	Remicade	153	1,541	195
other	CROHN'S DISEASE	Gastrointestinal disorders	Switched to Remicade	19	298	23
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Standard Therapy	124	1,121	153
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Remicade	281	1,541	376
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Switched to Remicade	37	298	48
serious	ANAEMIA	Blood and lymphatic system disorders	Standard Therapy	5	1,121	6

1 to 10 of 2,019Source ClinicalTrials.gov

See all 2,019 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Therapy
Total, all-cause mortality	Remicade
Total, all-cause mortality	Switched to Remicade
Total, other adverse events	Standard Therapy	173	1,121
Total, other adverse events	Remicade	441	1,541
Total, other adverse events	Switched to Remicade	51	298
Total, serious adverse events	Standard Therapy	391	1,121
Total, serious adverse events	Remicade	792	1,541
Total, serious adverse events	Switched to Remicade	136	298

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28025307	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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