Postmarketing Safety Surveillance European Registry of Cr... | NCT00705614

NCT00705614

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Remicade Group	Particpiants with no prior exposure to Remicade, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who start on Remicade will constitute the Remicade Group, regardless of whether they continue with Remicade or switch to another treatment.	Biological: Remicade
Standard Therapy Group	Participants who are being treated with standard therapy and are not adequately maintained and will be offered an alternative treatment that does not include Remicade. Standard therapy participants must not have previously received Remicade.
Switched to Remicade Group	Participants who started in the Standard Therapy Group but switched over to Remicade sometime during the follow-up period. Participants who switch to Remicade are evaluated in the Standard Therapy group until the time of the switch and are evaluated in the Switched to Remicade group thereafter.	Biological: Remicade

Name	Type	Description	Arm Group Labels	Other Names
Remicade	Biological	The treating physician will determine the treatment regimen and dose of Remicade.	Remicade Group Switched to Remicade Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Serious Infections	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.	Up to 5 Years
Number of Participants With Infusion-Related Reactions/Hypersensitivity	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.	Up to 5 Years
Number of Participant Fatalities	The number of participant fatalities was evaluated throughout the study.	Up to 5 Years
Number of Participants With New or Worsening Congestive Heart Failure	The number of participants with new or worsening congestive heart failure was evaluated throughout the study.	Up to 5 Years
Number of Participants With Demyelinating Neurological Disorders	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.

Secondary Outcomes

Measure	Description	Time Frame
Participant Assessment of Overall Health Status By Study Visit	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age, of either sex, and of any race.
Must have active or fistulizing CD and must have experienced at least 1 of the following:
- failed a tapering regimen of corticosteroids and will be initiating immunosuppressive therapy
- required corticosteroid treatments for the previous 6 months and will be initiating immunosuppressive therapy
- luminal or fistulizing CD, which, in the treating physician's judgment, qualifies for initiation of Remicade.
Willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
Must be evaluated for active and inactive (latent) tuberculosis (TB) at the Baseline Visit. TB evaluation will consist of TB history questions (eg, medical history, possible previous contact with TB, TB vaccination history). TB evaluation and TB screening (eg, skin test, chest x-ray) are required when a subject starts treatment with Remicade. In these cases, subjects must be screened for TB within 3 months prior to initiating Remicade treatment.

Exclusion Criteria:

Female who is pregnant or nursing.
Treated with Remicade prior to Baseline.
Previously treated with other tumor necrosis factor (TNF)-active agents and other investigational drugs for CD prior to Baseline.
Active or untreated latent TB or other severe infections such as sepsis, abscesses, or opportunistic infections.
Moderate or severe heart failure (New York Heart Association [NYHA] Class III: subjects with marked limitation of activity; they are comfortable only at rest/Class IV: subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).
Have lymphoproliferative disorders (eg, lymphoma) or malignancies.
In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
Are participating in any other clinical trials (excluding registries).

In addition, subjects will be excluded from treatment with Remicade if any of the criteria listed below are met:

Females of childbearing potential unwilling to use a medically accepted method of birth control during treatment with Remicade and to continue its use for at least 6 months after the last Remicade treatment.
History of hypersensitivity to murine proteins or to any excipients of Remicade formulation (sucrose, polysorbate 80, monobasic sodium phosphate, and dibasic sodium phosphate).
Other conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC).

PubMed Identifier	Type	Citation	Retractions
28025307	Result	D'Haens G, Reinisch W, Colombel JF, Panes J, Ghosh S, Prantera C, Lindgren S, Hommes DW, Huang Z, Boice J, Huyck S, Cornillie F; ENCORE investigators. Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn's Disease Treated With Infliximab [Remicade(R)] or Conventional Therapy. J Crohns Colitis. 2017 Jun 1;11(6):680-689. doi: 10.1093/ecco-jcc/jjw221.

Arm/Group Information

ID	Title	Description
FG000	Remicade	Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
FG001	Standard Therapy Group	Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment. Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Remicade	Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
BG001	Standard Therapy Group

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Number of Participants With Serious Infections

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.

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.

Posted

Number

Participants

Up to 5 Years

ID	Title	Description
OG000	Remicade	Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard Therapy	Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins