Post Marketing Observational Study on Venezuelan Patients With Psoriasis

This study has suspended participant recruitment.
(Delayed)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( Abbott (Venezuela) )
ClinicalTrials.gov Identifier:
NCT01758705
First received: December 26, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the HRQoL, work productivity and activity impairment in patients with psoriasis using adalimumab.


Condition
Moderate to Severe Chronic Plaque Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study; Clinical Effectiveness and Impact on Patient Reported Outcomes in Venezuelan Patients With Psoriasis After 16 Weeks of ADA Therapy

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate [ Time Frame: From Week 0 to Week 16 ] [ Designated as safety issue: No ]
  • Change in Percentage of patients with clinical difference in DLQI (Dermatology Life Quality Index) score [ Time Frame: From Week 0 to Week 16 ] [ Designated as safety issue: No ]
    Clinical difference is defined by a minimal important difference (MID) in DLQI score between 2.3-5 at 16 weeks


Secondary Outcome Measures:
  • Mean change of PASI score [ Time Frame: From week 0 to week 16 ] [ Designated as safety issue: No ]
  • Mean change of DLQI score [ Time Frame: From week 0 to week 16 ] [ Designated as safety issue: No ]
  • Changes in Psoriatic Arthritis Response Criteria (PsARC) score [ Time Frame: From week 0 to week 16 ] [ Designated as safety issue: No ]
  • Mean change of Hospital Anxiety and Depression Score (HADS) [ Time Frame: From week 0 to week 16 ] [ Designated as safety issue: No ]
  • Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score [ Time Frame: From week 0 to week 16 ] [ Designated as safety issue: No ]
  • Percentage of subjects with Serious Adverse Events (SAEs) [ Time Frame: Up to week 16 ] [ Designated as safety issue: Yes ]
    Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer

  • Discontinuation of adalimumab for any reason. [ Time Frame: Up to week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1
Cohort 1

  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

Subjects male or female with moderate to severe chronic plaque psoriasis with or without psoriatic arthritis. Patients with history of psoriatic arthritis or articular symptoms must be evaluated by a Rheumatologist.

Criteria

Inclusion Criteria:

  • Subjects with moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis, who have the indication for adalimumab because they need systemic therapy or because they have had failure to phototherapy, or to other systemic or topical treatments
  • Subjects that are not receiving biologic therapy in the last 12 weeks or classical therapy in the past 4 weeks and/or phototherapy in the last 2 weeks. Topical therapy will be allowed, to a constant dose and will not be used within 24 hours prior to the visit
  • Patients under previous treatment with any experimental drug will have a minimum washout period of five half-lives
  • Subjects must be capable to understand and willing to give a written informed consent form to release information and to comply with the requirements of the study protocol

Exclusion Criteria:

  • Subjects should not be enrolled if they cannot be treated in accordance with the local product label approved in Venezuela
  • Subjects enrolled into another study or under treatment with an investigational product
  • History of viral hepatitis B infection or HIV
  • History of neurologic symptoms suggestive of central nervous system demyelinating disease
  • History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
  • Active TB infection before initiating adalimumab treatment or latent TB infection not able to complete prophylactic treatment
  • Pregnant or lactating female. Pregnancy will be tested before entering the study in fertile women. Women in fertile age must be advised by the physician, to use a clinically accepted contraceptive method (contraceptive pills, IUDs, barrier devices as condoms or abstinence)
  • History of congestive heart failure (CHF)
  • Any another condition that according to the criteria of the participating investigator represents an obstacle for study conduction and / or subjects to an unacceptable risks
  • Subjects with active infection including chronic or localized infections until infections are controlled
  • History of sensitive to latex or other component of the syringe
  • Subjects who requires concomitant phototherapy and systemic therapy during adalimumab therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758705

Locations
Venezuela
Site Reference ID/Investigator# 96774
Ciudad Bolivar, Venezuela
Site Reference ID/Investigator# 96773
Maracaibo, Venezuela
Site Reference ID/Investigator# 96776
Maracay, Venezuela
Site Reference ID/Investigator# 96775
Petare, Venezuela
Site Reference ID/Investigator# 96777
Valencia, Venezuela
Sponsors and Collaborators
Abbott (Venezuela)
Investigators
Study Chair: Natali Serra-Bonett, MD Abbott
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( Abbott (Venezuela) )
ClinicalTrials.gov Identifier: NCT01758705     History of Changes
Other Study ID Numbers: P13-709
Study First Received: December 26, 2012
Last Updated: March 20, 2014
Health Authority: Venezuela: Ethics Committee

Keywords provided by AbbVie:
Related to Health Quality of Life
Venezuelan Patients
Psoriasis
Patient Reported Outcomes

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014