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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01316224
First received: February 14, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

Psoriatic Arthritis as a comorbidity that affects a large subgroup of patients with moderate to severe psoriasis, with a distinct collection of symptoms around the world. The study purpose is to describe the effect of adalimumab treatment in patients with active moderate to severe psoriasis regarding Psoriatic Arthritis symptoms.


Condition
Psoriasis
Psoriatic Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in the subjects proportion who present some Arthritis Psoriatic symptoms or signs during the following up visit [ Time Frame: at Baseline, Week 24, and Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the subject proportion that achieved a PASI (Psoriasis Area and Severity Index) reduction on ≥50% [ Time Frame: at Baseline, Week 24, and Week 48 ] [ Designated as safety issue: No ]
  • Changes in mean and deviation standard in Quality of life measured by SF-36 [ Time Frame: at Baseline, Week 24, and Week 48 ] [ Designated as safety issue: No ]
  • Change in the subject proportion that develop Psoriatic Arthritis according to CASPAR (Classification criteria for Psoriatic Arthritis) criteria [ Time Frame: at Baseline, Week 24, and Week 48 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single group study
Patients with moderate or severe psoriasis in treatment with Adalimumab

Detailed Description:

Open label, post marketing observational study, designed to describe the prevalence of Psoriatic Arthritis in patients with Psoriasis in treatment with adalimumab and their impact on Quality of life.

  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

Patients 18 year old and older who had diagnosis of moderate and severe Psoriasis

Criteria

Inclusion Criteria:

  • Subject has a documented clinical diagnosis of psoriasis, as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
  • Subject has indication of psoriasis systemic therapy
  • If female, subject 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:

  • Patients who have active infections
  • Patients participating into another study or clinical trial
  • Any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects patients to an unacceptable risk
  • History of active tuberculosis (TB), history of histoplasmosis or listeriosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316224

Locations
Colombia
Site Reference ID/Investigator# 48347
Barranquilla, Colombia
Site Reference ID/Investigator# 53045
Barranquilla, Colombia
Site Reference ID/Investigator# 48349
Barranquilla, Colombia
Site Reference ID/Investigator# 78533
Bogota, Colombia
Site Reference ID/Investigator# 53047
Bogota, Colombia
Site Reference ID/Investigator# 59342
Cali, Colombia
Site Reference ID/Investigator# 48346
Cali, Colombia
Site Reference ID/Investigator# 48345
Cali, Colombia
Site Reference ID/Investigator# 48348
Cartagena, Colombia
Site Reference ID/Investigator# 53050
Cartagena, Colombia
Site Reference ID/Investigator# 48342
Cartagena, Colombia
Site Reference ID/Investigator# 48353
Medellin, Colombia
Site Reference ID/Investigator# 53046
Medellin, Colombia
Site Reference ID/Investigator# 48351
Medellin, Colombia
Site Reference ID/Investigator# 53049
Medellin, Colombia
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Manuel G Uribe Abbvie SAS
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01316224     History of Changes
Other Study ID Numbers: P12-598
Study First Received: February 14, 2011
Last Updated: April 11, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by AbbVie:
Psoriasis
Incidence
Quality of Life
Psoriatic Arthritis
Prevalence

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Psoriasis
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014