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

NCT00705614 | Completed Results DMC

• 1 other identifier: P03164
• Study Type: observational
• Target: 2,662
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  Up to 5 Years

Secondary Outcomes (7)

• Participant Assessment of Overall Health Status By Study Visit

  Up to 5 Years

• The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit

  Up to 5 Years

• Work/Daily Activity Status Score By Study Visit

  Up to 5 Years

• Number of Participants With a Draining Fistula By Study Visit

  Up to 5 Years

• Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months

  Up to 5 Years

Study Arms (3)

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

Interventions

Remicade BIOLOGICAL

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

Also known as: Infliximab, SCH 215596

Remicade Group; Switched to Remicade Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 28025307 RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 26, 2008
• Study Start: July 1, 2003
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 22, 2017
• Results First Posted: August 26, 2014

Record last verified: 2017-02