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

Crohn's Disease Clinical Trial

— ENCORE  

Official title:

Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705614
• Other study ID #: P03164
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: February 9, 2015
• Start date: July 2003
• Est. completion date: February 2013

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial Summary

Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2662
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Remicade
The treating physician will determine the treatment regimen and dose of Remicade.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 5 Years	Yes
Primary	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	Yes
Primary	Number of Participant Fatalities	The number of participant fatalities was evaluated throughout the study.	Up to 5 Years	Yes
Primary	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	Yes
Primary	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.	Up to 5 Years	Yes
Primary	Number of Participants With Hematologic Conditions	The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.	Up to 5 Years	Yes
Primary	Number of Participants With Lymphoproliferative Disorders/Malignancies	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.	Up to 5 Years	Yes
Secondary	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.	Up to 5 Years	No
Secondary	The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit	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.	Up to 5 Years	No
Secondary	Work/Daily Activity Status Score By Study Visit	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.	Up to 5 Years	No
Secondary	Number of Participants With a Draining Fistula By Study Visit	The number of participants with a draining fistula was evaluated at each study visit.	Up to 5 Years	No
Secondary	Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months	The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.	Up to 5 Years	No
Secondary	Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months	The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.	Up to 5 Years	No
Secondary	Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months	The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.	Up to 5 Years	No