European Safety Registry in Ulcerative Colitis (Study P04808AM2) - Full Text View

Sponsors and Collaborators:	Schering-Plough Centocor, Inc.
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705484

Purpose

This is a prospective, safety surveillance registry in patients with moderate-to-severe active ulcerative colitis (UC).

Condition	Intervention
Ulcerative Colitis	Biological: Remicade

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Ulcerative Colitis European Registry: A Prospective, Observational, Non-Interventional, Post-Marketing Safety Surveillance Program

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Evaluate the long-term safety of Remicade based on reports of prespecified categories of adverse events. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Data regarding overall health status, disease activity based on MAYO score, IBDQ score, work/daily activity status, number & duration of hospitalizations for UC, number of & reason for surgical procedures for UC & colon dysplasias [ Time Frame: Up to 5 years. ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	June 2007
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Remicade Group Subjects with no prior exposure to Remicade, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit.	Biological: Remicade The treating physician will determine the treatment regimen and dose of Remicade.
Standard Therapy Group Subjects who are being treated with standard therapy and whose symptoms are not adequately controlled and who are scheduled for an alternative treatment that does not include Remicade. Standard therapy subjects must not have previously received Remicade for UC or any other condition.
Switch to Remicade Group Subjects who started in the Standard Therapy Group but switched over to Remicade sometime during the follow-up period.	Biological: Remicade The treating physician will determine the treatment regimen and dose of Remicade.

Detailed Description:

This is a prospective, observational, post-marketing safety surveillance registry of UC subjects treated with Remicade or another standard therapy.

Registry centers are targeted to enroll a total of 2000 subjects (1000 Remicade subjects and 1000 standard therapy subjects) and to follow them for a period of up to 5 years. Subjects who started the registry on standard therapy may switch over to Remicade.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult subjects, ages 18 years and older, with a diagnosis of moderate-to-severe active UC with no previous exposure to Remicade will be eligible to enroll in the registry.

Criteria

Inclusion Criteria:

18 years of age, of either sex, and of any race.
Moderate-to-severe active UC, as defined by assessment by the treating physician.
Must, within 30 days of Baseline, either:
- Initiate or have a dose increase of immunosuppressive drug(s), including but not limited to systemic steroids (budesonide is considered a topical steroid), AZA, or methotrexate, or
- Initiate Remicade
Must be 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) as suggested by local guidelines or as required by the Remicade label for subjects starting Remicade.

Exclusion Criteria:

Female who is known to be pregnant or nursing.
Treated with Remicade prior to Baseline.
Previously treated with any other (investigational) biological drug for UC, including Remicade, prior to Baseline.
In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
Participating in a blinded trial.

In addition, subjects with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705484

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

United States, New Jersey
Coordinating Location	Recruiting
Kenilworth, New Jersey, United States, 07033

Sponsors and Collaborators

Schering-Plough

Centocor, Inc.

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04808
Study First Received:	June 23, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00705484 History of Changes
Health Authority:	European Union: European Medicines Agency

Study placed in the following topic categories:

Anti-Inflammatory Agents
Digestive System Diseases
Infliximab
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Antirheumatic Agents
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Infliximab
Ulcer
Colonic Diseases
Gastrointestinal Agents
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Antirheumatic Agents
Gastroenteritis
Colitis
Dermatologic Agents

ClinicalTrials.gov processed this record on May 06, 2009