Moderate to Severe Chronic Plaque PsoriasisNCT01758705
Post Marketing Observational Study on Venezuelan Patients With Psoriasis
An observational study of Moderate to Severe Chronic Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: Observational Study; Clinical Effectiveness and Impact on Patient Reported Outcomes in Venezuelan Patients With Psoriasis After 16 Weeks of ADA Therapy
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.
- Keywords
- Psoriasis, Related to Health Quality of Life, Patient Reported Outcomes, Venezuelan Patients
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cohort 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate
Measured: From Week 0 to Week 16
Change in Percentage of patients with clinical difference in DLQI (Dermatology Life Quality Index) score
Clinical difference is defined by a minimal important difference (MID) in DLQI score between 2.3-5 at 16 weeks
Measured: From Week 0 to Week 16
Secondary outcomes (7)
Mean change of PASI score
Measured: From week 0 to week 16
Mean change of DLQI score
Measured: From week 0 to week 16
Changes in Psoriatic Arthritis Response Criteria (PsARC) score
Measured: From week 0 to week 16
Mean change of Hospital Anxiety and Depression Score (HADS)
Measured: From week 0 to week 16
Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score
Measured: From week 0 to week 16
Percentage of subjects with Serious Adverse Events (SAEs)
Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer
Measured: Up to week 16
Discontinuation of adalimumab for any reason.
Measured: Up to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natali Serra-Bonett, MD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758705
- Sponsor's protocol ID
- P13-709
- Status last verified
- Nov 2016
- First submitted
- 26 Dec 2012
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study; Clinical Effectiveness and Impact on Patient Reported Outcomes in Venezuelan Patients With Psoriasis After 16 Weeks of ADA Therapy
- ClinicalTrials.gov ID
- NCT01758705
- Acronym / sponsor ID
- P13-709
- Keywords
- Psoriasis, Related to Health Quality of Life, Patient Reported Outcomes, Venezuelan Patients
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Cohort 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate
Time frame: From Week 0 to Week 16
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
7 secondary outcomes
Mean change of PASI score
Time frame: From week 0 to week 16
Mean change of DLQI score
Time frame: From week 0 to week 16
Changes in Psoriatic Arthritis Response Criteria (PsARC) score
Time frame: From week 0 to week 16
Mean change of Hospital Anxiety and Depression Score (HADS)
Time frame: From week 0 to week 16
Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score
Time frame: From week 0 to week 16
Percentage of subjects with Serious Adverse Events (SAEs)
Time frame: Up to week 16
Discontinuation of adalimumab for any reason.
Time frame: Up to week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natali Serra-Bonett, MD study chair
Abbott
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Chronic Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate (time frame: From Week 0 to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.