Post Marketing Observational Study on Venezuelan Patients With Psoriasis
This study is enrolling participants by invitation only.
Sponsor:
Abbott (Venezuela)
Information provided by (Responsible Party):
AbbVie ( Abbott (Venezuela) )
ClinicalTrials.gov Identifier:
NCT01758705
First received: December 26, 2012
Last updated: March 1, 2013
Last verified: February 2013
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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: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (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:
- Male or female ≥ 18 years old
- 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
More Information
Additional Information:
Related Info 
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 1, 2013 |
| 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 May 19, 2013