Post-Marketing, Observational Study of HUMIRA® (Adalimumab) in Patients With Chronic Plaque Psoriasis (Ps) - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00799877

Purpose

To evaluate the long-term safety of Humira® in Ps patients

Condition	Intervention
Chronic Plaque Psoriasis	Biological: HUMIRA® (adalimumab)

MedlinePlus related topics: Psoriasis

Drug Information available for: Adalimumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A 5-Year, Post-Marketing, Observational Study of HUMIRA® (Adalimumab) in Patients With Chronic Plaque Psoriasis (Ps)

Further study details as provided by Abbott:

Primary Outcome Measures:

Adverse Events of Interest and SAEs [ Time Frame: As occur ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PRO - DLQI, WPAI, Patient Global Assessment [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Physician's Global Assessment [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	6000
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2022 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with Psoriasis taking Humira	Biological: HUMIRA® (adalimumab) As prescribed by treating physician.

Detailed Description:

ESPRIT is a 10 year registry of patients taking HUMIRA for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with HUMIRA. No registry specific testing will be performed. Patients will be asked to provide data on their experiences with HUMIRA approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.

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

Dermatology clinic

Criteria

Inclusion Criteria:

Humira® therapy is indicated and has been prescribed according to the product label;
Newly prescribed Humira® therapy (i.e. naïve to Humira®) treatment OR
Currently participating in an Abbott sponsored investigational Psoriasis trial and is receiving Humira®;
Patient is willing to consent to data being collected and provided to Abbott;
Patient is capable of and willing to give written informed consent and to comply with the requirements of the study protocol.

Exclusion Criteria:

Patients should not be enrolled if they cannot be treated in accordance with the local product label.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799877

Contacts

Contact: Jeannine Parrish

1-215-390-1353

jeannine.parrish@unitedbiosource.com

Locations

United States, California
	Recruiting
San Jose, California, United States, 95123
	Recruiting
Los Angelos, California, United States, 90045
United States, Georgia
	Recruiting
Alpharetta, Georgia, United States, 30022
United States, Kentucky
	Recruiting
Corbin, Kentucky, United States, 40701
United States, New York
	Recruiting
New York, New York, United States, 10019

Sponsors and Collaborators

Abbott

More Information

Responsible Party:	Abbott ( Beverly Paperiello )
Study ID Numbers:	P10-023
Study First Received:	November 26, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00799877
Health Authority:	United States: Institutional Review Board

Keywords provided by Abbott:

Psoriasis
Moderate Psoriasis
Severe Psoriasis

Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis
Registry

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Adalimumab
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009