PsoriasisPhase 3NCT01001208
The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis
A Phase 3 study testing Methotrexate and Etanercept in people with Psoriasis, run by Amgen.
Trial summary
The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Methotrexate and Etanercept
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 478 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Feb 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
- Is capable of understanding and giving written, voluntary informed consent before study screening
- Male or female ≥18 years of age at time of screening
- Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity)
- Has involved body surface area (BSA) ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline
- Is a candidate for systemic therapy or phototherapy in the opinion of the investigator
- Has a negative test for hepatitis B surface antigen and hepatitis C antibody
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- Has a negative purified protein derivative test within 30 days prior to the first IP dose. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48-72 hours after test is placed. Patients with a positive tuberculin skin test (if less than or equal to 14 mm of induration) are allowed if they have a history of Bacillus Calmette-Guerin vaccination with a negative Quantiferon test in the past year, no symptoms per tuberculosis worksheet, and a negative chest X ray.
- Has a negative serum pregnancy test within 28 days before initiating Investigational Product (IP) and negative urine pregnancy test at baseline for females (except those at least 3 years post menopausal or surgically sterile)
- Females are willing to use highly effective form of birth control (decided upon with the investigator) during the study and for 3 months after the end of treatment (except women at least 3 years post menopausal or surgically sterile)
- Males are willing to use highly effective form of birth control (decided upon with the investigator) during the study and for 5 months after the end of treatment (except for men who are surgically sterile or whose female partners are at least 3 years post menopausal, surgically sterile, or are using a highly effective form of birth control)
- Men with a pregnant female partner are willing to use effective methods (decided upon with the investigator) to ensure that an unborn child is not exposed to IP via semen
- Patient or designee must have the ability to inject etanercept subcutaneously
Who cannot join
- Skin-disease related
- Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on psoriasis.
- Medical conditions
- Has significant concurrent medical conditions, including:
- Type 1 diabetes
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- Poorly controlled type 2 diabetes (hemoglobin A1c > 8.5)
- Symptomatic heart failure (New York Heart Association [NYHA] class II, III, or IV)
- Myocardial infarction within the last year
- Current or history of unstable angina pectoris within the last year
- Uncontrolled hypertension as defined by a resting blood pressure ≥ 160/95 mmHg prior to randomization (confirmed by a repeat assessment)
- Severe chronic pulmonary disease (eg, requiring oxygen therapy)
- No major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis
- Multiple sclerosis or any other demyelinating disease
- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first IP dose. If malignancy occurred more than 5 years ago, documentation of disease-free state since treatment is required.
- Known immunodeficiency syndromes including human immunodeficiency virus (HIV)
- Uncontrolled, clinically significant history of renal disease
- Alcoholic hepatitis
- Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the patient
- Has any active CTC grade 2 or higher infection (including chronic or localized infections) within 30 days prior to screening, at screening, or during screening period prior to first investigational product (IP) dose
- Is pregnant or breast feeding
- Has any condition that could, in the opinion of the investigator, compromise the patient's ability to give written consent and/or comply with the study procedures, such as a history of substance abuse or a psychiatric condition Methotrexate contraindications or precautions
- Has a family history of heritable liver disease (eg, hemachromatosis, Wilson's disease)
- Has a history of or evidence at screening or baseline of alcohol abuse, alcoholic liver disease, or other clinically significant liver disease
- Is unwilling or unable to limit alcohol consumption during the 24-week trial period (allowable limits are: not more than 4 drinks a week, not more than 2 drinks in a single day. 1 drink = 1 (5 oz) glass of wine = 1.5 oz liquor = 12 oz of beer or hard cider)
- Has an estimated total cumulative methotrexate exposure (by medical history) exceeding 1000 mg, unless a subsequent liver biopsy has demonstrated no grade IIIb or greater injury
- Has a history of significant methotrexate toxicity including pneumonitis or significant cytopenias
- Laboratory abnormalities
- Has laboratory abnormalities at screening, including:
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > the upper limit of normal (if screen fail for abnormal AST/ALT, 1 repeat measurement is allowed)
- Serum total bilirubin ≥ 1.5 mg/dL
- Abnormal serum albumin (< 3.5 g/dL)
- Hemoglobin < 11 g/dL
- Platelet count < 125,000 /mm^3
- White blood cell count < 3,500 cells/mm^3
- Absolute neutrophil count < 1500/mm^3
- Estimated creatinine clearance < 50 mL/min (Cockroft-Gault formula, calculated value to be provided to sites)
- Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the patient from completing the study or will interfere with the interpretation of the study results
- Washouts and disallowed medications
- Has used any of the following therapies within 14 days of IP initiation:
- Ultraviolet light B therapy
- Topical cyclosporine or calcineurin inhibitors
- Topical vitamin A or D analog preparations
- Class III through VII topical steroids (exception: permitted on the scalp, axillae, and groin)
- Has used any of the following therapies within 28 days of IP initiation:
- Intravenous or oral calcineurin inhibitors
- Ultraviolet light A therapy
- Psoralen and ultraviolet light A therapy
- Oral retinoids
- Class I or II topical steroids
- Anthralin
- Any other systemic psoriasis therapy (eg, cyclosporine), including oral or parenteral corticosteroids
- Cyclophosphamide
- Sulfasalazine
- Has used methotrexate within 28 days of IP initiation. Patients with prior use of methotrexate must be excluded if subject discontinued because of a clinically significant adverse event (eg, severe skin reactions, methotrexate-induced lung disease, or any other adverse event that the investigator feels might cause this study to be detrimental to the patient)
- Has used biologic therapies (other than interleukin (IL)12/IL23 inhibitors or anti-timor necrosis factor (TNF) agents) within 3 months of IP initiation
- Has used an IL12/23 inhibitor within 6 months of IP initiation (eg, CNTO 1275, ABT 874)
- Has used one or more anti-TNF agents (eg, etanercept, adalimumab, infliximab) within 3 months of IP initiation. Patients with prior use of an anti-TNF agent must be excluded if the subject discontinued for lack of efficacy or a clinically significant adverse event (eg, serious infection, neurologic event, malignancy, hematologic event, or any other adverse event that the investigator feels might cause this study to be detrimental to the patient).
- Has previously used efalizumab (Raptiva®).
- Other investigational procedures are excluded.
- currently enrolled in or has not yet completed at least 30 days or 5 half-lives (if applicable; whichever is longer) since ending other investigational device or drug study(s), or is receiving other investigational agent(s).
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adding Methotrexate to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24.
- Conditions
- Psoriasis
- Being tested
- Methotrexate, Etanercept, Placebo
- Keywords
- Etanercept, Methotrexate, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate tablets over-encapsulated for blinding
EtanerceptDrug
Also called Enbrel
1 mL for subcutaneous injection
PlaceboDrug
Matching placebo to methotrexate capsules
| Study group | Role | What they receive |
|---|---|---|
| Etanercept Plus Methotrexate | Experimental | Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period. Receives: Drug: Methotrexate; Drug: Etanercept |
| Etanercept Plus Placebo | Active comparator | Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen. Receives: Drug: Etanercept; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI 75 Response at Week 24
Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Measured: Baseline and 24 Weeks
Secondary outcomes (9)
PASI 50 Response at Week 24
Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Measured: Baseline and 24 Weeks
Static Physician Global Assessment (sPGA) Response at Week 24
Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 24. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Measured: Week 24
PASI 50 Response at Week 12
Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Measured: Baseline and 12 Weeks
PASI 75 Response at Week 12
Percentage of participants achieving at least a 75% decrease (i.e. improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Measured: Baseline and 12 Weeks
Static Physician Global Assessment (sPGA) Response at Week 12
Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 12. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Measured: Week 12
PASI 90 Response at Week 12
Percentage of participants achieving at least a 90% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Measured: Baseline and 12 Weeks
PASI 90 Response at Week 24
Percentage of participants achieving at least a 90% decrese (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Measured: Baseline and 24 Weeks
Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 12 score; a positive change from Baseline therefore indicates improvement.
Measured: Baseline and 12 Weeks
Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 24 score; a positive change from Baseline therefore indicates improvement.
Measured: Baseline and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionFeb 2011
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 AmgenThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001208
- Sponsor's protocol ID
- 20070559
- Status last verified
- Jul 2013
- First submitted
- 15 Oct 2009
- Last updated
- 12 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adding Methotrexate to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01001208
- Acronym / sponsor ID
- 20070559
- Conditions
- Psoriasis
- Keywords
- Etanercept, Methotrexate, Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Posted 12 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept Plus Methotrexate | Experimental | Drug: Methotrexate, Drug: EtanerceptParticipants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period. |
| Etanercept Plus Placebo | Active comparator | Drug: Etanercept, Drug: PlaceboParticipants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Is capable of understanding and giving written, voluntary informed consent before study screening
- Male or female ≥18 years of age at time of screening
- Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity)
- Has involved body surface area (BSA) ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline
- Is a candidate for systemic therapy or phototherapy in the opinion of the investigator
Key exclusion criteria (61 listed)
- Skin-disease related
- Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on psoriasis.
- Medical conditions
- Has significant concurrent medical conditions, including:
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 |
|---|---|---|
| MethotrexateMethotrexate tablets over-encapsulated for blinding | Drug | Etanercept Plus Methotrexate |
| EtanerceptAlso: Enbrel1 mL for subcutaneous injection | Drug | Etanercept Plus Methotrexate, Etanercept Plus Placebo |
| PlaceboMatching placebo to methotrexate capsules | Drug | Etanercept Plus Placebo |
Primary outcome
PASI 75 Response at Week 24
Time frame: Baseline and 24 Weeks
Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
9 secondary outcomes
PASI 50 Response at Week 24
Time frame: Baseline and 24 Weeks
Static Physician Global Assessment (sPGA) Response at Week 24
Time frame: Week 24
PASI 50 Response at Week 12
Time frame: Baseline and 12 Weeks
PASI 75 Response at Week 12
Time frame: Baseline and 12 Weeks
Static Physician Global Assessment (sPGA) Response at Week 12
Time frame: Week 12
PASI 90 Response at Week 12
Time frame: Baseline and 12 Weeks
PASI 90 Response at Week 24
Time frame: Baseline and 24 Weeks
Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12
Time frame: Baseline and 12 Weeks
Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24
Time frame: Baseline and 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate and Etanercept in people with Psoriasis, run by Amgen.
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 61 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 12 Aug 2013. 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 12 Aug 2013). 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 75 Response at Week 24 (time frame: Baseline and 24 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 12 Aug 2013.