PsoriasisPhase 4NCT00581555
Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
A Phase 4 study testing Etanercept in people with Psoriasis, run by Pfizer.
Trial summary
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between age 18 and 70 years
- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.
Who cannot join
- Evidence of skin conditions other than psoriasis
- Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening
- ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
- Corticosteroid dose of prednisone >10 mg/day
- Serious infection
Show all 11Show fewer
- Receipt of any live vaccine
- Abnormal hematology or chemistry
- Body mass index (BMI) > 38
- Pregnancy or Breastfeeding
- Significant concurrent medical conditions
About this study
Official title: A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.
- Conditions
- Psoriasis
- Being tested
- Etanercept, Placebo
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Etanercept 50 mg QW initiated during taper of ciclosporin
PlaceboOther
Randomized to placebo during taper of ciclosporin
| Study group | Role | What they receive |
|---|---|---|
| etanercept | Experimental | Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. Receives: Drug: Etanercept |
| placebo | Placebo comparator | Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.
Measured: Randomization to Week 24.
Secondary outcomes (8)
PASI Area Under the Curve (AUC) Between Randomization and Week 24
PASI AUC = Area under the curve from randomization (Week 6) to Week 24.
Measured: Randomization to Week 24.
Change From Randomization in PGA Score to Week 24
PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.
Measured: Randomization to Week 24.
Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
Relapse was defined as the loss of 50% improvement in PASI.
Measured: Randomization to Week 24.
Probability of Being Relapse Free During the 24 Weeks After Randomization
Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.
Measured: Randomization to Week 24.
Percent (%) Change of PASI Score From Randomization to Week 24
Percent improvement in PASI score was calculated from Week 6 to Week 24.
Measured: Randomization to Week 24.
Change From Randomization in DLQI to Week 24
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Measured: Randomization to Week 24.
DLQI at Each Visit From Baseline
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Measured: Baseline to Week 24.
Percentage of Rebound Effects
Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.
Measured: Baseline to Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581555
- Sponsor's protocol ID
- 0881A6-410
- Status last verified
- Mar 2012
- First submitted
- 21 Dec 2007
- Last updated
- 23 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Micali G, Wilsmann-Theis D, Mallbris L, Gallo G, Marino V, Brault Y, Germain JM. Etanercept reduces symptoms and severity of psoriasis after cessation of cyclosporine therapy: results of the SCORE study. Acta Derm Venereol. 2015 Jan;95(1):57-61. doi: 10.2340/00015555-1845.
PubMed 24682319
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy
- ClinicalTrials.gov ID
- NCT00581555
- Acronym / sponsor ID
- 0881A6-410
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 23 Apr 2012
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 use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etanercept | Experimental | Drug: EtanerceptParticipants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. |
| placebo | Placebo comparator | Other: PlaceboParticipants were administered placebo subcutaneously once a week after an initial course of ciclosporin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between age 18 and 70 years
- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.
Key exclusion criteria (11 listed)
- Evidence of skin conditions other than psoriasis
- Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening
- ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
- Corticosteroid dose of prednisone >10 mg/day
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 |
|---|---|---|
| EtanerceptAlso: EnbrelEtanercept 50 mg QW initiated during taper of ciclosporin | Drug | etanercept |
| PlaceboRandomized to placebo during taper of ciclosporin | Other | placebo |
Primary outcome
Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
Time frame: Randomization to Week 24.
PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.
8 secondary outcomes
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Time frame: Randomization to Week 24.
Change From Randomization in PGA Score to Week 24
Time frame: Randomization to Week 24.
Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
Time frame: Randomization to Week 24.
Probability of Being Relapse Free During the 24 Weeks After Randomization
Time frame: Randomization to Week 24.
Percent (%) Change of PASI Score From Randomization to Week 24
Time frame: Randomization to Week 24.
Change From Randomization in DLQI to Week 24
Time frame: Randomization to Week 24.
DLQI at Each Visit From Baseline
Time frame: Baseline to Week 24.
Percentage of Rebound Effects
Time frame: Baseline to Week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24682319Micali G, Wilsmann-Theis D, Mallbris L, Gallo G, Marino V, Brault Y, Germain JM. Etanercept reduces symptoms and severity of psoriasis after cessation of cyclosporine therapy: results of the SCORE study. Acta Derm Venereol. 2015 Jan;95(1):57-61. doi: 10.2340/00015555-1845.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept in people with Psoriasis, run by Pfizer.
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 11 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 23 Apr 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) (time frame: Randomization to Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00581555, which also lists 1 linked publication.
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 23 Apr 2012.