PsoriasisPhase 3DOSENCT00833053
Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
A Phase 3 study testing Infliximab and Infliximab and methotrexate in people with Psoriasis, run by Merck Sharp & Dohme LLC.
Trial summary
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Infliximab and Infliximab and methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Apr 2011
- Phase
- Phase 3
- 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
- Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
- Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
- Subjects must be at least 18 years old
- Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
- Subjects must not be pregnant and must meet contraceptive requirements
- Subjects must meet tuberculosis screening criteria
- Subjects must meet laboratory and medical history screening requirements
Who cannot join
- Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
- Subjects already using certain investigational, biological, or immunosuppressive drugs
- Subjects with certain comorbid conditions
- Subjects who currently have or have a history of certain infections
- Subjects who have recently received live virus or bacterial vaccinations
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
About this study
Official title: A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.
- Conditions
- Psoriasis
- Being tested
- Infliximab, Infliximab and methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Remicade, SCH 215596
Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
Infliximab and methotrexateDrug
Also called Remicade, SCH 215596
Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
| Study group | Role | What they receive |
|---|---|---|
| IFX q 6 weeks | Experimental | Not described Receives: Drug: Infliximab |
| IFX + MTX | Experimental | Not described Receives: Drug: Infliximab and methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
Measured: Baseline, Week 28
Secondary outcomes (6)
Number of Participants With A PASI-50 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.
Measured: Baseline, Week 28
Number of Participants With A PASI-90 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.
Measured: Baseline, Week 28
Number of Participants With A PASI-100 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.
Measured: Baseline, Week 28
Change From Baseline in Mean Participant Raw PASI Scores at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.
Measured: Baseline, Week 28
Dermatology Life Quality Index (DLQI) at Week 28
The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.
Measured: Week 28
Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28
The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.
Measured: Baseline, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: In Amendment 1 of P05319 \[NCT 00779675\], the option to enroll into this study, was discontinued due to low numbers of participants with suboptimal response.
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 Merck Sharp & Dohme LLCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833053
- Sponsor's protocol ID
- P05315
- Other IDs
- EUDRACT: 2008-000454-12
- Acronym
- DOSE
- Status last verified
- Mar 2017
- First submitted
- 29 Jan 2009
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00833053
- Acronym / sponsor ID
- DOSE / P05315
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In Amendment 1 of P05319 \[NCT 00779675\], the option to enroll into this study, was discontinued due to low numbers of participants with suboptimal response.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 26 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFX q 6 weeks | Experimental | Drug: Infliximab |
| IFX + MTX | Experimental | Drug: Infliximab and methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
- Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
- Subjects must be at least 18 years old
- Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
- Subjects must not be pregnant and must meet contraceptive requirements
Key exclusion criteria (6 listed)
- Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
- Subjects already using certain investigational, biological, or immunosuppressive drugs
- Subjects with certain comorbid conditions
- Subjects who currently have or have a history of certain infections
- Subjects who have recently received live virus or bacterial vaccinations
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 |
|---|---|---|
| InfliximabAlso: Remicade, SCH 215596Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks | Drug | IFX q 6 weeks |
| Infliximab and methotrexateAlso: Remicade, SCH 215596Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly) | Drug | IFX + MTX |
Primary outcome
Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
Time frame: Baseline, Week 28
The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
6 secondary outcomes
Number of Participants With A PASI-50 Response at Week 28
Time frame: Baseline, Week 28
Number of Participants With A PASI-90 Response at Week 28
Time frame: Baseline, Week 28
Number of Participants With A PASI-100 Response at Week 28
Time frame: Baseline, Week 28
Change From Baseline in Mean Participant Raw PASI Scores at Week 28
Time frame: Baseline, Week 28
Dermatology Life Quality Index (DLQI) at Week 28
Time frame: Week 28
Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28
Time frame: Baseline, Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infliximab and Infliximab and methotrexate in people with Psoriasis, run by Merck Sharp & Dohme LLC.
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 7 inclusion and 6 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 12 Apr 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Jul 2012). 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?
Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 (time frame: Baseline, Week 28). 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 12 Apr 2017.