PsoriasisPhase 1/2NCT00368654
Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy
A Phase 1/2 study testing Methotrexate and Raptiva in people with Psoriasis, run by University of California, Davis at 1 site in United States.
Trial summary
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Methotrexate and Raptiva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2008
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate to severe plaque-type psoriasis
- A candidate for systemic therapy or phototherapy
- Not using prescription systemic therapies for psoriasis prior to starting the study
- Not using efalizumab within 3 months prior to starting the study
- We are seeking adults who:
- Have moderate to severe plaque-type psoriasis
Show all 13Show fewer
- Are generally healthy
- Are not hypersensitive to Raptiva® (efalizumab) or any of its components.
- Are not pregnant or lactating women
- You will:
- Be interviewed and examined
- Have blood drawn
- Be injecting the study medication
Who cannot join
- Hypersensitivity to Raptiva or any of its components
- Pregnant or lactating women
- History of liver disease or abnormal liver enzymes
- History of chronic infection or malignancy
- History of significant hematologic abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center Department of Dermatology
Sacramento, California, 95816
About this study
Official title: An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
Read the detailed description
The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly
- Conditions
- Psoriasis
- Being tested
- Methotrexate, Raptiva
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Initial dose 5 mg, then 15 mg per week
RaptivaDrug
Also called Efalizumab
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Monotherapy with Raptiva alone Receives: Drug: Raptiva |
| B | Experimental | Combination therapy with both Raptiva and Methotrexate Receives: Drug: Methotrexate; Drug: Raptiva |
| C | Experimental | Continue Raptiva, discontinue methotrexate Receives: Drug: Raptiva |
| D | Experimental | Continue combination therapy with both Raptiva and Methotrexate Receives: Drug: Methotrexate; Drug: Raptiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI -- Psoriasis Area and Severity Index
(PASI) - given by numerical score, the index shows the severity of psoriasis.
Measured: 16 vs. 36 weeks, depending on study arm
Secondary outcomes (1)
Adverse Events (AE)
measured by whether or not AE was serious
Measured: 16 vs. 36 weeks, depending on study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2006 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 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 University of California, DavisThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Chai Sue Lee, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368654
- Sponsor's protocol ID
- 200513613
- Status last verified
- May 2018
- First submitted
- 24 Aug 2006
- Last updated
- 14 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy
- ClinicalTrials.gov ID
- NCT00368654
- Acronym / sponsor ID
- 200513613
- Conditions
- Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Aug 2006 (estimated)
- Results
- Posted 14 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
Detailed description
The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: RaptivaMonotherapy with Raptiva alone |
| B | Experimental | Drug: Methotrexate, Drug: RaptivaCombination therapy with both Raptiva and Methotrexate |
| C | Experimental | Drug: RaptivaContinue Raptiva, discontinue methotrexate |
| D | Experimental | Drug: Methotrexate, Drug: RaptivaContinue combination therapy with both Raptiva and Methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Moderate to severe plaque-type psoriasis
- A candidate for systemic therapy or phototherapy
- Not using prescription systemic therapies for psoriasis prior to starting the study
- Not using efalizumab within 3 months prior to starting the study
- Have moderate to severe plaque-type psoriasis
Key exclusion criteria (5 listed)
- Hypersensitivity to Raptiva or any of its components
- Pregnant or lactating women
- History of liver disease or abnormal liver enzymes
- History of chronic infection or malignancy
- History of significant hematologic abnormalities
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 |
|---|---|---|
| MethotrexateInitial dose 5 mg, then 15 mg per week | Drug | B, D |
| RaptivaAlso: EfalizumabRaptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg | Drug | A, B, C, D |
Primary outcome
PASI -- Psoriasis Area and Severity Index
Time frame: 16 vs. 36 weeks, depending on study arm
(PASI) - given by numerical score, the index shows the severity of psoriasis.
1 secondary outcome
Adverse Events (AE)
Time frame: 16 vs. 36 weeks, depending on study arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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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.
Chai Sue Lee, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Methotrexate and Raptiva in people with Psoriasis, run by University of California, Davis at 1 site in United States.
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 13 inclusion and 5 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 14 Jun 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Jun 2018). 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?
PASI -- Psoriasis Area and Severity Index (time frame: 16 vs. 36 weeks, depending on study arm). 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 14 Jun 2018.