PsoriasisPhase 4NCT00336973
A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent
A Phase 4 study testing efalizumab in people with Psoriasis, run by Genentech, Inc..
Trial summary
This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- efalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Feb 2008
- 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
- Have chronic (6 months or greater) moderate or worse plaque psoriasis
- Have had an inadequate response to at least 12 weeks of treatment with an anti-TNF agent, where an inadequate response is defined as: PGA ratings of moderate (3), severe (4), or very severe (5), and BSA involvement of 5% or greater
- Be a candidate for systemic therapy or phototherapy in the opinion of the investigator
- Be naive to efalizumab treatment
- Weigh no more than 200 kg
- For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab
Who cannot join
- Have a history of psoriatic arthritis that meets one of the following criteria: Is not controlled with non-steroidal anti-inflammatory drugs (NSAIDs);Requires the use of disease modifying antirheumatic drugs (DMARDs), including biologics while enrolled in the study; Please note that if, following enrollment, a subject requires treatment with a DMARD, study drug treatment should be discontinued and the subject should be moved into the observation period of the study. The subject should have the observation period assessments performed at the appropriate intervals as per the protocol
- Have a history of hypersensitivity to efalizumab or any of its components
- Are using any excluded therapy
- Are currently abusing alcohol or illegal drugs
- Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, which 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.
- Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
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- Are seropositive 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.
- Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test will be performed at the screening visit. Subjects with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded.
- Have the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
- Are pregnant or lactating women
- Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
- Have a history of thrombocytopenia
- Have a history of clinically significant hemolytic or unexplained anemia
- Have been exposed to any experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the screening visit
- Have had any previous exposure to efalizumab
- Have been vaccinated with a live virus or live bacteria within the 14 days prior to the first dose of efalizumab
- Have any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug or would significantly interfere with the subject's ability to comply with the provisions of this protocol
About this study
Official title: A Phase IV Open-Label Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Raptiva (Efalizumab) in Adult Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent
This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent. The study will consist of a screening period, a treatment period, and an observation period. All subjects will begin in the screening period (the length of which is dependent on the previous anti-TNF agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0 through Day 168.
- Conditions
- Psoriasis
- Being tested
- efalizumab
- Keywords
- Plaque Psoriasis, Raptiva, Anti-TNF
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
Subcutaneous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: efalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Measured: Day 84
Secondary outcomes (3)
Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Measured: Day 168
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Measured: Day 84
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Measured: Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2008
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 PsoriasisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ivor Caro, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336973
- Sponsor's protocol ID
- ACD3780g
- Status last verified
- Apr 2009
- First submitted
- 13 Jun 2006
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open-Label Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Raptiva (Efalizumab) in Adult Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent
- ClinicalTrials.gov ID
- NCT00336973
- Acronym / sponsor ID
- ACD3780g
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, Raptiva, Anti-TNF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2008 (actual)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Posted 5 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent. The study will consist of a screening period, a treatment period, and an observation period. All subjects will begin in the screening period (the length of which is dependent on the previous anti-TNF agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0 through Day 168.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: efalizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have chronic (6 months or greater) moderate or worse plaque psoriasis
- Have had an inadequate response to at least 12 weeks of treatment with an anti-TNF agent, where an inadequate response is defined as: PGA ratings of moderate (3), severe (4), or very severe (5), and BSA involvement of 5% or greater
- Be a candidate for systemic therapy or phototherapy in the opinion of the investigator
- Be naive to efalizumab treatment
- Weigh no more than 200 kg
Key exclusion criteria (17 listed)
- Have a history of psoriatic arthritis that meets one of the following criteria: Is not controlled with non-steroidal anti-inflammatory drugs (NSAIDs);Requires the use of disease modifying antirheumatic drugs (DMARDs), including biologics while enrolled in the study; Please note that if, following enrollment, a subject requires treatment with a DMARD, study drug treatment should be discontinued and the subject should be moved into the observation period of the study. The subject should have the observation period assessments performed at the appropriate intervals as per the protocol
- Have a history of hypersensitivity to efalizumab or any of its components
- Are using any excluded therapy
- Are currently abusing alcohol or illegal drugs
- Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, which 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 |
|---|---|---|
| efalizumabSubcutaneous repeating dose | Drug | 1 |
Primary outcome
Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)
Time frame: Day 84
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
3 secondary outcomes
Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)
Time frame: Day 168
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
Time frame: Day 84
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
Time frame: Day 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- 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.
Ivor Caro, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing efalizumab in people with Psoriasis, run by Genentech, Inc..
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 6 inclusion and 17 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 Jul 2015. 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. 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 5 Jun 2009). 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 Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) (time frame: Day 84). 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 23 Jul 2015.