Post Marketing Observational Study on Venezuelan Patients With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01758705
Recruitment Status : Withdrawn
First Posted : January 1, 2013
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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 or disease
Moderate to Severe Chronic Plaque Psoriasis

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : February 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Cohort 1
Cohort 1

Primary Outcome Measures :
  1. Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate [ Time Frame: From Week 0 to Week 16 ]
  2. Change in Percentage of patients with clinical difference in DLQI (Dermatology Life Quality Index) score [ Time Frame: From Week 0 to Week 16 ]
    Clinical difference is defined by a minimal important difference (MID) in DLQI score between 2.3-5 at 16 weeks

Secondary Outcome Measures :
  1. Mean change of PASI score [ Time Frame: From week 0 to week 16 ]
  2. Mean change of DLQI score [ Time Frame: From week 0 to week 16 ]
  3. Changes in Psoriatic Arthritis Response Criteria (PsARC) score [ Time Frame: From week 0 to week 16 ]
  4. Mean change of Hospital Anxiety and Depression Score (HADS) [ Time Frame: From week 0 to week 16 ]
  5. Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score [ Time Frame: From week 0 to week 16 ]
  6. Percentage of subjects with Serious Adverse Events (SAEs) [ Time Frame: Up to week 16 ]
    Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer

  7. Discontinuation of adalimumab for any reason. [ Time Frame: Up to week 16 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01758705

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Chair: Natali Serra-Bonett, MD Abbott

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01758705     History of Changes
Other Study ID Numbers: P13-709
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Related to Health Quality of Life
Patient Reported Outcomes
Venezuelan Patients

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases