|- candidate number||4590|
|- NTR Number||NTR1559|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2008|
|- Secondary IDs||80-82500-98-01006 ZonMW|
|- Public Title||An independent prospective randomised controlled trial comparing the efficacy and cost effectiveness of infliximab and etanercept in 'high need' patients with moderate to severe chronic plaque type psoriasis.|
|- Scientific Title||An independent prospective randomised controlled trial comparing the efficacy and cost effectiveness of infliximab and etanercept in 'high need' patients with moderate to severe chronic plaque type psoriasis.|
|- ACRONYM||PIECE study|
|- hypothesis||We hypothesize that after 12 weeks treatment with infliximab 75 % of the patients will reach a PASI75, whereas after treatment with etarnacept 50% will reach a PASI75. |
|- Healt Condition(s) or Problem(s) studied||Psoriasis, Cost-effectiveness , Etanercept, Infliximab |
|- Inclusion criteria||1. Adults patients (18-75 years of age) |
2. Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10.
3. Failed, contraindicated and/or intolerant to UV therapy, and methotrexate or cyclosporin.
4. Informed consent.
5. Able to complete Dutch questionnaires.
|- Exclusion criteria||1. Pregnancy and lactation.|
2. Active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis.
3. Malignancy in last 10 years, except BCC and cervical in situ cancer.
4. Demyelinating disease.
5. Congestive heart failure.
6. Allergic and hypersensitivity reactions to study drugs or ingredients.
7. Any live virus or bacterial vaccination within 3 months.
8. Severe liver- or kidney function disorders (3 times upper limits of the parameters).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-jan-2009|
|- planned closingdate||1-jul-2011|
|- Target number of participants||120|
|- Interventions||Etanercept will be self administered by subcutaneous injection, 50 mg twice weekly. |
Infliximab is an intravenous treatment with 5 mg/kg at week 0,2,6 and then every 8 weeks.
At week 12, according to the PASI, patients continue therapy or switch to the other treatment up to week 24.
Thereafter, follow up is every two months up to one year.
|- Primary outcome||Efficacy: |
- PASI75 and PGA as clinical psoriasis severity measures at week 12 and 24.
-Improvement of HRQOL: Skindex-17, the generic SF-36 and PAGA.
-Treatment satisfaction: Treatment Medication Satisfaction Questionnaire (TMSQ) score.
- The incremental cost effectiveness ratio (ICER) of infliximab relative to etanercept will be calculated and estimated in terms of costs per QALY, by using the EQ-5D.
- Nonmedical costs and medical cost outside the hospital, using the Labor and Health Questionnaire.
|- Secondary outcome||- Duration of remission will be analysed.|
- Patients perspectives will be analysed.
- Presence of neutralising antibodies will be measured.
- Side effects will be evaluated.
- The improvement of nailpsoriasis will be evaluated.
|- Timepoints||Measurements will take place at baseline, week 12, 24, 32, 40 and 48.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.C.Q. Vries|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.C.Q. Vries|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Dermatology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background:
TNF antagonists such as etanercept and infliximab (biologics) have been approved for the treatment of moderate to severe psoriasis patients. In the Netherlands etanercept is the most frequently prescribed biological. Comparison analysis suggest that infliximab is more effective than etanercept. However, with several specific limitations. |
Costs associated with psoriasis care increase steeply due to the introduction of the biologics. Furthermore psoriasis has an enormous impact on patientsí health related quality of life.
There are no direct comparative studies available of infliximab and etanercept and existing studies did not include an economic evaluation of these expensive agents.
Thatís why we want to compare by an independent prospective RCT the efficacy and cost effectiveness of infliximab and etanercept by these patients.
1. Compare the clinical efficacy.
2. Compare patient reported outcomes on HRQOL, PAGA and treatment satisfaction.
3. Compare from a societal perspective the incremental cost effectiveness ratio
1. Duration of remission.
2. Patients perspectives.
4. Subgroup analyses in relation to (cost-) effectiveness and safety, and presence of neutralising antibodies.
5. Improvement of nailpsoriasis during both therapies.
This trial is a multi-centre, pharmaceutical independent, prospective randomised controlled trial comparing head-to-head infliximab and etanercept.
Patients (18-75 years of age) with moderate to severe chronic plaque type psoriasis who failed or have contraindications and/or are intolerant to ultraviolet therapy, and methotrexate or cyclosporin are eligible. Consecutive patients will be screened and, if eligible, randomized in a 1:1 ratio. In total, 120 patients will be included.
For 12 weeks, etanercept 50mg subcutaneous twice weekly or infliximab 5mg/kg intravenous. At week 12, according to the PASI patients will continue therapy or switch to the other treatment up to week 24.
Thereafter, patients will be followed every two months up to one year.
Main study parameters:
Efficacy: - PASI75, and PGA.
-Improvement of HRQOL: Skindex-17, generic SF-36 and PAGA.
-Treatment satisfaction: median changes TMSQ score.
- Economic evaluation: The difference between the cost effectiveness of the two treatment options will be assessed. The incremental cost effectiveness ratio (ICER) of infliximab will be calculated relative to etanercept. This incremental cost effectiveness ratio in terms of costs per QALY will be estimated. The quality of life estimates assessed with the EQ-5D.
|- Main changes (audit trail)|
|- RECORD||24-nov-2008 - 16-mei-2009|