Psoriatic ArthritisELANNCT01078610
Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine
An observational study of Psoriatic Arthritis, run by Abbott.
Trial summary
Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- adalimumab (Humira)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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: Community sample: patients with psoriatic arthritis.
Who may be able to join
- Active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy
Who cannot join
- Hypersensitivity against the drug or one of the other ingredients
- Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
- Moderate to severe cardiac insufficiency.
About this study
Official title: Long Term Documentation of the Safety and Efficacy as Well as the Effects on Quality of Life and Work Productivity in Patients With Psoriatic Arthritis Under HUMIRA® (Adalimumab) in Routine Clinical Practice
Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.
Read the detailed description
The primary objective of the Non-Interventional Study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value):
- The number of missed working days
- The self-assessed workability
- The severity of clinical symptoms (number of tender and swollen joints, C-reactive Protein and erythrocyte sedimentation rate respectively; total score Disease Activity Score 28, Psoriasis Area and Severity Index)
- The severity of functional impairment (Health Assessment Questionnaire)
- The health-related quality of life .
All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.
The secondary objective is to document the therapeutic success by the following variables:
- The number of physician visit
- The number and duration of hospitalization
- The number of days of impairment in non-occupational activities
- Pain, exhaustion/fatigue
- The reduction of number and dose of concomitant medication
- Patient's assessment of adalimumab therapy compared to previous therapies.
Target parameters for safety evaluation of adalimumab are:
- The evaluation of safety and tolerability by the documentation and analysis of serious adverse events (SAEs) and adverse events (AEs)
- Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases, especially diabetes type II, cardiovascular, liver, and renal insufficiencies, and related concomitant medications.
- Conditions
- Psoriatic Arthritis
- Being tested
- adalimumab (Humira)
- Keywords
- Psoriatic Arthritis, Long-term Observation, Humira, Safety, Effectiveness, Quality of Life, Work Productivity
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumab (Humira)Biological
Also called adalimumab, Humira
40 mg adalimumab (Humira) every other week.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis patients | Not described Receives: Biological: adalimumab (Humira) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events
Measured: Months 0, 3, 6, 12, 24, 36, 48, 60
Secondary outcomes (1)
Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies.
Measured: Months 0, 3, 6, 12, 24, 36, 48, 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
Why it stopped: Study stopped prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Simianer, MD, Study director, Abbott Germany, Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078610
- Sponsor's protocol ID
- P12-023
- Acronym
- ELAN
- Status last verified
- Jun 2012
- First submitted
- 26 Feb 2010
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Documentation of the Safety and Efficacy as Well as the Effects on Quality of Life and Work Productivity in Patients With Psoriatic Arthritis Under HUMIRA® (Adalimumab) in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01078610
- Acronym / sponsor ID
- ELAN / P12-023
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, Long-term Observation, Humira, Safety, Effectiveness, Quality of Life, Work Productivity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study stopped prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- First posted
- 2 Mar 2010 (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.
Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.
Detailed description
The primary objective of the Non-Interventional Study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value):
- The number of missed working days
- The self-assessed workability
- The severity of clinical symptoms (number of tender and swollen joints, C-reactive Protein and erythrocyte sedimentation rate respectively; total score Disease Activity Score 28, Psoriasis Area and Severity Index)
- The severity of functional impairment (Health Assessment Questionnaire)
- The health-related quality of life .
All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.
The secondary objective is to document the therapeutic success by the following variables:
- The number of physician visit
- The number and duration of hospitalization
- The number of days of impairment in non-occupational activities
- Pain, exhaustion/fatigue
- The reduction of number and dose of concomitant medication
- Patient's assessment of adalimumab therapy compared to previous therapies.
Target parameters for safety evaluation of adalimumab are:
- The evaluation of safety and tolerability by the documentation and analysis of serious adverse events (SAEs) and adverse events (AEs)
- Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases, especially diabetes type II, cardiovascular, liver, and renal insufficiencies, and related concomitant medications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis patients | – | Biological: adalimumab (Humira) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample: patients with psoriatic arthritis.
Key inclusion criteria (1 listed)
- Active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy
Key exclusion criteria (3 listed)
- Hypersensitivity against the drug or one of the other ingredients
- Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
- Moderate to severe cardiac insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumab (Humira)Also: adalimumab, Humira40 mg adalimumab (Humira) every other week. | Biological | Psoriatic arthritis patients |
Primary outcome
Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events
Time frame: Months 0, 3, 6, 12, 24, 36, 48, 60
1 secondary outcome
Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies.
Time frame: Months 0, 3, 6, 12, 24, 36, 48, 60
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 10 Aug 2012.
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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.
Stefan Simianer, MD study director
Abbott Germany, Medical Department
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by 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 1 inclusion and 3 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 10 Aug 2012. 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?
Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events (time frame: Months 0, 3, 6, 12, 24, 36, 48, 60). 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 10 Aug 2012.