10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus - Full Text View

10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus (PEER)

This study is currently recruiting participants.

Verified by Novartis, November 2009

First Received: December 5, 2007 Last Updated: November 2, 2009 History of Changes

Sponsor:	Novartis
Collaborator:	Clinical Research Computing Unit (University of Pennsylvania)
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00568997

Purpose

This study will examine the incidence of lymphoma in pediatric subjects who have been exposed to pimecrolimus 1% cream.

Condition	Intervention
Atopic Dermatitis	Drug: Pimecrolimus

Study Type:	Observational
Official Title:	A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Pimecrolimus 1% Cream

Resource links provided by NLM:

MedlinePlus related topics: Eczema Lymphoma

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Rate of lymphoma in pediatric subjects who have used pimecrolimus 1% cream.

Secondary Outcome Measures:

Rate of thyroid cancer in patients under study
Total number of systemic malignancies reported in study compared to those reported in SEER (Surveillance Epidemiology and End Results) database
Investigation of dose response in the incidence of lymphoma

Estimated Enrollment:	4000
Study Start Date:	June 2004
Estimated Study Completion Date:	April 2018

Groups/Cohorts	Assigned Interventions
1 Single-group	Drug: Pimecrolimus Pimecrolimus 1% cream

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both

Study Population

Children (ages 2-17 years)

Criteria

Inclusion Criteria:

males and females
greater than or equal to 2 years and less than or equal to 17 years at enrollment
diagnosis of atopic dermatitis (confirmed by treating physician)
applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks

Exclusion Criteria:

past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease
past or present use of oral immunosuppressive therapy

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568997

Contacts

Contact: Novartis Pharma

862-778-8300

Locations

United States, Pennsylvania
Registry	Recruiting
Pennsylvania, Pennsylvania, United States

Sponsors and Collaborators

Novartis

Clinical Research Computing Unit (University of Pennsylvania)

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981C2311
Study First Received:	December 5, 2007
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00568997 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Atopic dermatitis, eczema, children, pediatric patients, pimecrolimus, registry

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dermatitis, Atopic
Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Hypersensitivity
Sensory System Agents
Therapeutic Uses
Skin Diseases, Eczematous
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Skin Diseases, Genetic
Dermatologic Agents

Dermatitis
Immune System Diseases
Skin Diseases
Pimecrolimus
Immunosuppressive Agents
Pharmacologic Actions
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009