Chronic Plaque PsoriasisPhase 4TRUSTNCT00739882
TRUST Study: Raptiva ® in Hand & Foot Psoriasis
A Phase 4 study testing Efalizumab - anti CD11a recombinant human monoclonal antibody in people with Chronic Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Austria.
Trial summary
To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H\&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- Efalizumab - anti CD11a recombinant human monoclonal antibody
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2008to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with chronic (disease history of at least 6 months from diagnosis) moderate to severe plaque psoriasis involving the hands and/or feet (PGA - H\&F ratings of 3 or 4) at screening, who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA. Subjects will be outpatients.
- Stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period).
- At least 18 years old.
- For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. For men, during the participation, it is mandatory to practice birth control, as there are not existing data on the effect of Raptiva ® on spermatogenesis.
- Discontinuation of any systemic psoriasis treatment at study entry. No washout period is required for these traditional systemic psoriasis agents prior to starting study treatment.
- Discontinuation of all biological agents at least 3 months prior to first study injection.
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- Discontinuation of any investigational drug or treatment at least 3 months prior to SD 1 or as per washout requirements from previous protocol.
- Willingness and ability to comply with the protocol requirements for the duration of the study.
- Written informed consent, given prior to any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw his/her consent at any time without prejudice to future medical care.
Who cannot join
- Hypersensitivity to efalizumab or to any of the excipients
- Current use of any prohibited therapy (systemic or topical treatments for psoriasis, immunosuppressive drugs, any other experimental drug, etc)
- Previous or current exposure to Raptiva®
- History of or ongoing alcohol or drug abuse
- History of or an ongoing opportunistic infection (e.g. systemic fungal infection, parasites) or any other serious infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the subject will be excluded.
- Seropositivity for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Subjects will undergo testing during screening, and any subjects who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded.
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- History of active or latent tuberculosis within one year prior to screening (to be determined by assessment according to national and/or local recommendation).
- Presence or history of malignancy, including lymphoproliferative disorders.
- Pregnancy or breast-feeding
- History of hepatic cirrhosis, regardless of cause or severity
- History of thrombocytopenia, haemolytic anaemia, clinically significant anaemia, a white blood cell count <4,000 cells/μL or >14,000 cells/μL, a haematocrit (HCT) <30% or a haemoglobin (Hgb) level <11 g/dL, a platelet count <150,000 cells/μL
- Hepatic enzyme levels ≥3 times the upper limit of normal or serum creatinine level ≥2 times the upper limit of normal
- Vaccination with a live or live-attenuated virus or live or live-attenuated bacteria vaccine within the 14 days prior to the first dose of Raptiva®
- Any medical condition that, in the judgment of the Investigator, would jeopardise the subject's safety following exposure to investigational medicinal product (Raptiva® or placebo equivalent) or would significantly interfere with the Subject's ability to comply with the provisions of this protocol.
- Other specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant for of psoriasis.
- Immunodeficiencies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Multicentre, Randomised, Double-blind, Placebo Controlled, Trial to Evaluate the Safety and Efficacy of Raptiva ® in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis Involving Hands and/or Feet, With or Without Pustules.
To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H\&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A (PUVA).
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Efalizumab - anti CD11a recombinant human monoclonal antibody, Placebo
- Keywords
- Efalizumab,, Chronic plaque psoriasis, moderate to severe, involving, hands, feet
- Medical subject headings
- Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efalizumab - anti CD11a recombinant human monoclonal antibodyDrug
Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
PlaceboDrug
Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
| Study group | Role | What they receive |
|---|---|---|
| Efalizumab | Active comparator | Not described Receives: Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12
The proportion of subjects achieving a PGA - H\&F rating of clear, almost clear, or mild at Week 12:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet
Measured: 12 weeks
Secondary outcomes (5)
Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12
The proportion of participants achieving a PGA - H\&F rating of clear, or almost clear, at Week 12:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet
Measured: 12 weeks
Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24
The proportion of participants achieving a PGA - H\&F rating of clear, almost clear, or mild at Week 24:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet
Measured: 24 weeks
Proportion of Participants From the Initial Placebo Group Achieving a PGA - H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.
The proportion of participants achieving a PGA - H\&F rating of clear, or almost clear, at Week 24:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet
Measured: 24 weeks
Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12
The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.
Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement
Measured: 12 weeks
Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12
The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.
Cleared = 100% improvement; Excellent = 75-99% improvement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: The study was terminated after the European Medicines Agency recommended to suspend the marketing authorisation of Raptiva in the European Union
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.
- Other trials for Chronic Plaque 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Selenko-Gebauer, MD, Study director, Merck Serono S.A., Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739882
- Sponsor's protocol ID
- 27808
- Acronym
- TRUST
- Status last verified
- Jan 2014
- First submitted
- 20 Aug 2008
- Last updated
- 27 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Multicentre, Randomised, Double-blind, Placebo Controlled, Trial to Evaluate the Safety and Efficacy of Raptiva ® in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis Involving Hands and/or Feet, With or Without Pustules.
- ClinicalTrials.gov ID
- NCT00739882
- Acronym / sponsor ID
- TRUST / 27808
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Efalizumab,, Chronic plaque psoriasis, moderate to severe, involving, hands, feet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after the European Medicines Agency recommended to suspend the marketing authorisation of Raptiva in the European Union
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Posted 30 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H\&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A (PUVA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efalizumab | Active comparator | Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject with chronic (disease history of at least 6 months from diagnosis) moderate to severe plaque psoriasis involving the hands and/or feet (PGA - H\&F ratings of 3 or 4) at screening, who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA. Subjects will be outpatients.
- Stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period).
- At least 18 years old.
- For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. For men, during the participation, it is mandatory to practice birth control, as there are not existing data on the effect of Raptiva ® on spermatogenesis.
- Discontinuation of any systemic psoriasis treatment at study entry. No washout period is required for these traditional systemic psoriasis agents prior to starting study treatment.
Key exclusion criteria (16 listed)
- Hypersensitivity to efalizumab or to any of the excipients
- Current use of any prohibited therapy (systemic or topical treatments for psoriasis, immunosuppressive drugs, any other experimental drug, etc)
- Previous or current exposure to Raptiva®
- History of or ongoing alcohol or drug abuse
- History of or an ongoing opportunistic infection (e.g. systemic fungal infection, parasites) or any other serious infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the subject will be excluded.
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 |
|---|---|---|
| Efalizumab - anti CD11a recombinant human monoclonal antibodyEach subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment. | Drug | Efalizumab |
| PlaceboPlacebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase) | Drug | Placebo |
Primary outcome
Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12
Time frame: 12 weeks
The proportion of subjects achieving a PGA - H\&F rating of clear, almost clear, or mild at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet
5 secondary outcomes
Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12
Time frame: 12 weeks
Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24
Time frame: 24 weeks
Proportion of Participants From the Initial Placebo Group Achieving a PGA - H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.
Time frame: 24 weeks
Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12
Time frame: 12 weeks
Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicole Selenko-Gebauer, MD study director
Merck Serono S.A., Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efalizumab - anti CD11a recombinant human monoclonal antibody in people with Chronic Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Austria.
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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. 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 30 Aug 2010). 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?
Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12 (time frame: 12 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 27 Feb 2014.