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Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment

NCT ID: NCT01316224

Last Updated: 2015-05-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-04-30

Brief Summary

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Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of participants with moderate or severe psoriasis. The purpose of this study was to describe the profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to evaluate adalimumab efficacy and safety profile.

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Detailed Description

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Psoriasis is a chronic inflammatory disease affecting 1% to 3% of the population worldwide. A significant portion (5%-40%) of participants with psoriasis develop PsA, a chronic inflammatory arthritis that causes progressive joint damage, reduced functionality and increased mortality risk. Skin disease typically manifests before arthritis in more than 80% of PsA participants, and psoriasis symptoms usually precede joint symptoms by an average of 10 years. Participants with psoriasis who have comorbid PsA incur substantially increased cost of care and experience greater impairment of physical functioning and quality of life compared with participants with psoriasis alone.

Conditions

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Psoriasis Psoriatic Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate or severe plaque psoriasis

Participants with moderate or severe plaque psoriasis treated with adalimumab

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
* Participant has indication of psoriasis systemic therapy
* If female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
* Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
* Contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration
* A vasectomized partner
* Total abstinence from sexual intercourse
* Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria

* Participants who have active infections
* Participants enrolled in another study or clinical trial
* Any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk
* History of active tuberculosis (TB), histoplasmosis or listeriosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuel G Uribe

Role: STUDY_DIRECTOR

Abbvie SAS

Locations

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Site Reference ID/Investigator# 48347

Barranquilla, , Colombia

Site Status

Site Reference ID/Investigator# 48349

Barranquilla, , Colombia

Site Status

Site Reference ID/Investigator# 53045

Barranquilla, , Colombia

Site Status

Site Reference ID/Investigator# 53047

Bogotá, , Colombia

Site Status

Site Reference ID/Investigator# 78533

Bogotá, , Colombia

Site Status

Site Reference ID/Investigator# 48345

Cali, , Colombia

Site Status

Site Reference ID/Investigator# 48346

Cali, , Colombia

Site Status

Site Reference ID/Investigator# 59342

Cali, , Colombia

Site Status

Site Reference ID/Investigator# 48342

Cartagena, , Colombia

Site Status

Site Reference ID/Investigator# 48348

Cartagena, , Colombia

Site Status

Site Reference ID/Investigator# 53050

Cartagena, , Colombia

Site Status

Site Reference ID/Investigator# 48351

Medellín, , Colombia

Site Status

Site Reference ID/Investigator# 48353

Medellín, , Colombia

Site Status

Site Reference ID/Investigator# 53046

Medellín, , Colombia

Site Status

Site Reference ID/Investigator# 53049

Medellín, , Colombia

Site Status

Countries

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Colombia

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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P12-598

Identifier Type: -

Identifier Source: org_study_id

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