Chronic Plaque PsoriasisPhase 4NCT00972543
Raptiva in Palm and Sole Psoriasis
A Phase 4 study testing Efalizumab (Raptiva) in people with Chronic Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany.
Trial summary
The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in subjects that are candidates for phototherapy… 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 (Raptiva)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to May 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
- To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria:
- Subjects must have moderate to severe chronic (disease history of at least 6 months from diagnosis) plaque psoriasis involving the palms and/or soles (PPPASI =/>5) at screening, and must be candidates for phototherapy and systemic therapies.
- Subjects must be outpatients.
- Subjects must have stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period).
- Subjects must not have received any systemic psoriasis medication at least 14 days prior to the first administration of investigational medicinal product.
- Subjects must not have received any topical psoriasis medication at least 14 days prior to the first administration of investigational medicinal product (emollients are allowed, as well as low potency steroids to the face and/or groin).
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- Subjects must be at least 18 years old at the time that the informed consent is obtained.
- Female subjects of childbearing potential must use an adequate method of contraception to prevent pregnancy and must agree to continue to practice adequate contraception for the duration of their participation in the study (up to the last safety follow up visit). For male subjects, it is mandatory to practice birth control during participation in the trial, as there are no data on the effect of Raptiva® on spermatogenesis. For the purposes of this trial, women of childbearing potential are defined as "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive." Adequate contraception is defined as two barrier methods, or one barrier method with spermicide, or an intrauterine device or use of the oral female contraceptive.
- Subjects must have discontinued all biological agents at least 3 months prior to the first study treatment injection.
- Subjects must have discontinued any investigational drug or treatment at least 3 months prior to study Day 0 and/or as per washout requirements from previous protocol.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- Subjects must have provided their written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent
Who cannot join
- To be eligible for inclusion in this trial, the subjects must not meet any of the following criteria:
- Hypersensitivity to Raptiva®/matching placebo or to any of their excipients.
- Current use of any prohibited therapy (systemic or topical treatments for psoriasis, such as retinoids; immunosuppressive drugs such as methotrexate, cyclosporine A, azathioprine, or mycophenolate mofetil, or any other experimental drug).
- Previous or current exposure to Raptiva®.
- History of or ongoing alcohol or drug abuse.
- History of or ongoing opportunistic infection or other serious infection. This includes any infections from the following list: Pneumocystis carinii, cytomegalovirus organ infections, Candida albicans (excluding simple localised muco-cutaneous infections), mycobacterium infections, Cryptococcus neoformans, Toxoplasma gondii, herpes simplex (excluding localised oral or genital muco-cutaneous infection), herpes zoster (excluding simple shingle eruption), cryptosporidium, Isospora belli, coccidioidomycosis, aspergillosis, histoplasmosis, and nocardiosis. This also includes diagnoses requiring more than 2 weeks of therapy, such as endocarditis and osteomyelitis treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression of or prophylaxis for any diagnosis, the subject will be excluded.
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- Seropositivity for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Subjects will undergo testing during screening; any subjects who are found to be seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded, and proper diagnosis and further therapy will be recommended.
- Presence of active tuberculosis.
- Presence or history of malignancy including lymphoproliferative disorders.
- Pregnancy or breast-feeding.
- History of hepatic cirrhosis, regardless of cause or severity.
- History or presence 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%, a haemoglobin (Hgb) level <11 g/dL, or 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 vaccine within the 14 days prior to the first dose of investigational medicinal product.
- 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 form of psoriasis.
- Immunodeficiencies.
- Signs and symptoms suggestive of transmissible spongiform encephalopathy or family history of such.
About this study
Official title: A Phase IV Multicentre, Randomized Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Raptiva in the Treatment of Subjects With Moderate to Severe Chronic Plaque Psoriasis Involving Palms and/or Soles, With or Without Pustules.
The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in subjects that are candidates for phototherapy or systemic therapies.
The rational of the trial is that psoriasis involving palms and/or soles is a painful condition associated with fissuring, scaling and in some instances with pustulation. Because of its localization, it is a disabling condition that limits dexterity and affects social interaction, leading to compromised quality of life; and this confers additional severity to that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a certain extent, the next step involves the addition of systemic treatments. Substances like methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and offer a new therapeutic approach.
Read more
The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic treatments has been described in numerous case reports and in one placebo-controlled phase IV study. However, in all cases, the number of subjects included was low, and in most cases the trials were not prospectively designed.
Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the validated PPPASI measure, it is necessary for scientific and ethical reasons to include a placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week open-label extended treatment period.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Efalizumab (Raptiva), Placebo
- Keywords
- Moderate to severe chronic plaque psoriasis, palms and/or soles, with or without pustules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efalizumab (Raptiva)Biological
Also called Raptiva
Double-blind phase 0.7mg/kg subcutaneously (sc), followed by 1mg/kg/wk sc for 12 weeks.
Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks.
PlaceboBiological
Double-blind phase sc Placebo for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Raptiva | Active comparator | Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks Receives: Biological: Efalizumab (Raptiva) |
| Placebo | Placebo comparator | Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Minimum possible score 0, maximum possible score 72.
Measured: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Static Physician Global Assessment Hands and Feet (sPGA - H&F)
Minimum possible score 0, maximum possible score 4.
Measured: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit
Psoriasis Area and Severity Index (PASI)
Minimum possible score 0, maximum possible score 72.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Static Physician Global Assessment (SPGA)
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
Measured: Measured at Screening, Day 0 and Day 7
Dynamic Physician's Global Assessment of Change (dPGA)
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
Measured: Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Secondary outcomes (30)
Participants With Direct Physical Examination Abnormalities
Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum
Measured: Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits
Complaint Directed Physical Examinations
Number of participants undergoing complaint directed physical examinations
Measured: Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)
Heart Rate
Measured: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Arterial Blood Pressure
Measured: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Temperature
Measured: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Weight Measurements
Measured: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Haemoglobin
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Haematocrit
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Red Cell Count
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - White Cell Count
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Platelets
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Neutrophils
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Lymphocytes
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Monocytes
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Eosinophils
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Basophils
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Sodium
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Potassium
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Urea
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Creatinine
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Total Bilirubin
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Total Protein
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Calcium
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Aspartate Transaminase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Alanine Transaminase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - C Reactive Protein
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Measured: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test
A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.
Measured: Measured at screening (Day -14 to Day -1)
Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test
A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.
Measured: Measured at screening (Day -14 to Day -1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionMay 2009
Why it stopped: The study was terminated after the European Medicines Evaluation 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
- Enrolment
- 6 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
- NCT00972543
- Sponsor's protocol ID
- 28861
- Status last verified
- Jan 2014
- First submitted
- 4 Sep 2009
- Last updated
- 13 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Multicentre, Randomized Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Raptiva in the Treatment of Subjects With Moderate to Severe Chronic Plaque Psoriasis Involving Palms and/or Soles, With or Without Pustules.
- ClinicalTrials.gov ID
- NCT00972543
- Acronym / sponsor ID
- 28861
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Moderate to severe chronic plaque psoriasis, palms and/or soles, with or without pustules
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after the European Medicines Evaluation Agency recommended to suspend the marketing authorisation of Raptiva in the European Union
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- First posted
- 7 Sep 2009 (estimated)
- Results
- Posted 2 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in subjects that are candidates for phototherapy or systemic therapies.
The rational of the trial is that psoriasis involving palms and/or soles is a painful condition associated with fissuring, scaling and in some instances with pustulation. Because of its localization, it is a disabling condition that limits dexterity and affects social interaction, leading to compromised quality of life; and this confers additional severity to that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a certain extent, the next step involves the addition of systemic treatments. Substances like methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and offer a new therapeutic approach.
The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic treatments has been described in numerous case reports and in one placebo-controlled phase IV study. However, in all cases, the number of subjects included was low, and in most cases the trials were not prospectively designed.
Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the validated PPPASI measure, it is necessary for scientific and ethical reasons to include a placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week open-label extended treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raptiva | Active comparator | Biological: Efalizumab (Raptiva)Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks |
| Placebo | Placebo comparator | Biological: PlaceboDouble-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria:
- Subjects must have moderate to severe chronic (disease history of at least 6 months from diagnosis) plaque psoriasis involving the palms and/or soles (PPPASI =/>5) at screening, and must be candidates for phototherapy and systemic therapies.
- Subjects must be outpatients.
- Subjects must have stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period).
- Subjects must not have received any systemic psoriasis medication at least 14 days prior to the first administration of investigational medicinal product.
Key exclusion criteria (18 listed)
- To be eligible for inclusion in this trial, the subjects must not meet any of the following criteria:
- Hypersensitivity to Raptiva®/matching placebo or to any of their excipients.
- Current use of any prohibited therapy (systemic or topical treatments for psoriasis, such as retinoids; immunosuppressive drugs such as methotrexate, cyclosporine A, azathioprine, or mycophenolate mofetil, or any other experimental drug).
- Previous or current exposure to Raptiva®.
- History of or ongoing alcohol or drug abuse.
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 (Raptiva)Also: RaptivaDouble-blind phase 0.7mg/kg subcutaneously (sc), followed by 1mg/kg/wk sc for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks. | Biological | Raptiva |
| PlaceboDouble-blind phase sc Placebo for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks. | Biological | Placebo |
Primary outcome
Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Time frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Minimum possible score 0, maximum possible score 72.
Static Physician Global Assessment Hands and Feet (sPGA - H&F)
Time frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit
Minimum possible score 0, maximum possible score 4.
Psoriasis Area and Severity Index (PASI)
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Minimum possible score 0, maximum possible score 72.
Static Physician Global Assessment (SPGA)
Time frame: Measured at Screening, Day 0 and Day 7
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
Dynamic Physician's Global Assessment of Change (dPGA)
Time frame: Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
30 secondary outcomes
Participants With Direct Physical Examination Abnormalities
Time frame: Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits
Complaint Directed Physical Examinations
Time frame: Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)
Heart Rate
Time frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Arterial Blood Pressure
Time frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Temperature
Time frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Weight Measurements
Time frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Haemoglobin
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Haematocrit
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Red Cell Count
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - White Cell Count
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Platelets
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Neutrophils
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Lymphocytes
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Monocytes
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Eosinophils
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Basophils
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Sodium
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Potassium
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Urea
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Creatinine
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Total Bilirubin
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Total Protein
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Calcium
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Aspartate Transaminase
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Alanine Transaminase
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - C Reactive Protein
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test
Time frame: Measured at screening (Day -14 to Day -1)
Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test
Time frame: Measured at screening (Day -14 to Day -1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efalizumab (Raptiva) in people with Chronic Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany.
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 12 inclusion and 18 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 13 Feb 2014. 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 2 Sep 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?
Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) (time frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits). The study lists 5 primary outcomes in all. 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 13 Feb 2014.