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

An observational study of Crohn's Disease, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Crohn's Disease
What is being tested?: Remicade
How many people: 2,662 participants
Where: No sites listed yet
Study dates: Jul 2003to Feb 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult subjects, ages 18 years and older, with a diagnosis of active or fistulizing CD with no previous exposure to Remicade will be eligible to enroll into the registry.

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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).

About this study

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

Conditions: Crohn's Disease
Being tested: Remicade
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemicadeBiological
Also called Infliximab, SCH 215596
The treating physician will determine the treatment regimen and dose of Remicade.

Study groups in NCT00705614
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Remicade

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Up to 5 Years
Number of Participant Fatalities
The number of participant fatalities was evaluated throughout the study.
Measured: 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.
Measured: 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.
Measured: Up to 5 Years
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.
Measured: Up to 5 Years
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.
Measured: Up to 5 Years

Secondary outcomes (7)

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.
Measured: Up to 5 Years
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.
Measured: Up to 5 Years
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.
Measured: Up to 5 Years
Number of Participants With a Draining Fistula By Study Visit
The number of participants with a draining fistula was evaluated at each study visit.
Measured: Up to 5 Years
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.
Measured: Up to 5 Years
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.
Measured: Up to 5 Years
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.
Measured: Up to 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2003Feb 2013

First posted26 Jun 2008 (estimated)
Study startJul 2003
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,662 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00705614
Sponsor's protocol ID: P03164
Acronym: ENCORE
Status last verified: Feb 2017
First submitted: 23 Jun 2008
Last updated: 22 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 28025307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy
ClinicalTrials.gov ID: NCT00705614
Acronym / sponsor ID: ENCORE / P03164
Conditions: Crohn's Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 2,662 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2003
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 26 Jun 2008 (estimated)
Results: Posted 26 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Remicade Group	–	Biological: RemicadeParticpiants 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.
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	–	Biological: RemicadeParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult subjects, ages 18 years and older, with a diagnosis of active or fistulizing CD with no previous exposure to Remicade will be eligible to enroll into the registry.

Key inclusion criteria (7 listed)

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:
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.

Key exclusion criteria (12 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RemicadeAlso: Infliximab, SCH 215596The treating physician will determine the treatment regimen and dose of Remicade.	Biological	Remicade Group, Switched to Remicade Group

Primary outcome

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

7 secondary outcomes

Participant Assessment of Overall Health Status By Study Visit
Time frame: Up to 5 Years
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Time frame: Up to 5 Years
Work/Daily Activity Status Score By Study Visit
Time frame: Up to 5 Years
Number of Participants With a Draining Fistula By Study Visit
Time frame: Up to 5 Years
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Time frame: Up to 5 Years
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Time frame: Up to 5 Years
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Time frame: Up to 5 Years

Results and safety

Results posted to the registry on 26 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remicade	1,541	1,023
Standard Therapy Group	1,121	800

Primary outcome: Number of Participants With Serious Infections

Time frame: Up to 5 Years. Number. Unit: Participants

Measure	Remicade n = 1541	Standard Therapy n = 1121	Switched to Remicade n = 298
Value	132	47	18

Population analysed: 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.

Primary outcome: Number of Participants With Infusion-Related Reactions/Hypersensitivity

Time frame: Up to 5 Years. Number. Unit: Participants

Measure	Remicade n = 1541	Standard Therapy n = 1121	Switched to Remicade n = 298
Value	173	1	28

Primary outcome: Number of Participant Fatalities

Time frame: Up to 5 Years. Number. Unit: Participants

Measure	Remicade n = 1541	Standard Therapy n = 1121	Switched to Remicade n = 298
Value	30	14	4

Primary outcome: Number of Participants With New or Worsening Congestive Heart Failure

Time frame: Up to 5 Years. Number. Unit: Participants

Measure	Remicade n = 1541	Standard Therapy n = 1121	Switched to Remicade n = 298
Value	1	1	0

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 5 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Therapy	391 of 1,121 (34.9%)	173 of 1,121 (15.4%)	Not reported
Remicade	792 of 1,541 (51.4%)	441 of 1,541 (28.6%)	Not reported
Switched to Remicade	136 of 298 (45.6%)	51 of 298 (17.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28025307D'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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serious Infections (time frame: Up to 5 Years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00705614, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.