search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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.


- candidate number4590
- NTR NumberNTR1559
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2008
- Secondary IDs80-82500-98-01006 ZonMW
- Public TitleAn 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 TitleAn 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.
- ACRONYMPIECE study
- hypothesisWe 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) studiedPsoriasis, Cost-effectiveness , Etanercept, Infliximab
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-jan-2009
- planned closingdate1-jul-2011
- Target number of participants120
- InterventionsEtanercept 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 outcomeEfficacy:
- 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.
- TimepointsMeasurements will take place at baseline, week 12, 24, 32, 40 and 48.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A.C.Q. Vries
- CONTACT for SCIENTIFIC QUERIESDrs. A.C.Q. Vries
- Sponsor/Initiator Academic Medical Center (AMC), Department of Dermatology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground: 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.

Objective:
Primary objectives:
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
Secondary objectives:
1. Duration of remission.
2. Patients perspectives.
3. Side-effects.
4. Subgroup analyses in relation to (cost-) effectiveness and safety, and presence of neutralising antibodies.
5. Improvement of nailpsoriasis during both therapies.

Study design:
This trial is a multi-centre, pharmaceutical independent, prospective randomised controlled trial comparing head-to-head infliximab and etanercept.

Study population:
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.

Intervention:
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)
- RECORD24-nov-2008 - 16-mei-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl