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

AbbVie

Status: Completed

Conditions: Psoriasis; Psoriatic Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01316224

P12-598

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Moderate or severe plaque psoriasis

Description:

Participants with moderate or severe plaque psoriasis treated with adalimumab