PsoriasisPhase 4NCT00161655
Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis
A Phase 4 study testing Etanercept and Methotrexate in people with Psoriasis and Arthritis, Psoriatic, run by Wyeth is now a wholly owned subsidiary of Pfizer at 8 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Arthritis, Psoriatic
- What is being tested?
- Etanercept and Methotrexate
- How many people
- 60 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Apr 2005to Dec 2006
- Phase
- Phase 4
- 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
Who may be able to join
- Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI score 8.
- Methotrexate >7.5 mg/week for the last 3 months
Who cannot join
- Predominantly guttate, erythrodermic or pustular psoriasis
- Other skin conditions than psoriasis
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Denmark2 sites
Study site
Fredriksberg Alle, Copenhagen
Study site
Gentofte Amtsygehus, Hellerup
Norway2 sites
Study site
Hudlegekontoret Akutten, Tromso
Study site
Rikshospitalet, Olso
Sweden2 sites
Study site
Lakarhuset, Vallingby
Study site
Lakarhuset Fasta Centrum, Farsta
About this study
Official title: A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy
The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.
- Conditions
- Psoriasis, Arthritis, Psoriatic
- Being tested
- Etanercept, Methotrexate
- Keywords
- Psoriasis, Arthritis
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
MethotrexateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
Secondary outcomes (2)
Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
and 90. Time to clear or almost clear on PGA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionAug 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161655
- Sponsor's protocol ID
- 0881A-101696
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2005
- Last updated
- 28 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy
- ClinicalTrials.gov ID
- NCT00161655
- Acronym / sponsor ID
- 0881A-101696
- Conditions
- Psoriasis, Arthritis, Psoriatic
- Keywords
- Psoriasis, Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Sep 2005 (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 purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI score 8.
- Methotrexate >7.5 mg/week for the last 3 months
Key exclusion criteria (2 listed)
- Predominantly guttate, erythrodermic or pustular psoriasis
- Other skin conditions than psoriasis
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 |
|---|---|---|
| Etanercept | Drug | – |
| Methotrexate | Drug | – |
Primary outcome
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
2 secondary outcomes
Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
and 90. Time to clear or almost clear on PGA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2009.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept and Methotrexate in people with Psoriasis and Arthritis, Psoriatic, run by Wyeth is now a wholly owned subsidiary of Pfizer at 8 sites in 4 countries.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Finland, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.. 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 28 Sep 2009.