Psoriasis VulgarisPhase 4NCT00640393
Safety and Efficacy of Combining nbUVB to Etanercept in Patients
A Phase 4 study testing Etanercept and nbUVB in people with Psoriasis Vulgaris, run by Innovaderm Research Inc. at 10 sites in Canada.
Trial summary
This study will provide data on the addition of narrow band ultra violet B (nbUVB) phototherapy to participants who have not shown an excellent response to three months of etanercept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Etanercept and nbUVB
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 10 sitesCanada
- Study dates
- Apr 2008to Mar 2010
- 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
- Age 18 or older;
- Patient with moderate to severe plaque psoriasis for whom a decision to use etanercept has been made;
- At the investigator discretion, patient who would benefit from systemic therapy;
- PASI (psoriasis area and severity index) ≥ 10 and BSA (body surface area affected by psoriasis) ≥ 10 at day 0;
- Unless surgically sterile (or at least 1 year post-menopausal for women), abstinent or homosexual, patient (men and women) willing to use adequate contraceptive method for at least 30 days before Day 0 and until one month after the last drug administration;
- Patient capable of giving informed consent;
Show all 9Show fewer
- Patient with normal or non clinically significant chest X ray within six months of screening;
- Patient with negative purified protein derivative (PPD) within 3 months of Day 0;
- Negative urine pregnancy test for women of childbearing potential
Who cannot join
- Patient used topical steroid, topical tar preparations, or other anti-psoriatic preparations except tar or salicylic acid shampoo or hydrocortisone for the face, scalp, genital and inframammary areas within two weeks of Day 0;
- Patient with presence of erythrodermic, pustular or a predominantly guttate psoriasis;
- At the investigator's discretion, patient with any significant infection within 30 days of screening or a patient at risk of septicemia;
- Patient with evidence of any skin condition that would interfere with the evaluation of psoriasis;
- Patient used investigational drugs within 12 weeks or three half-life of Day 0 whichever is longer;
- Patient used systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within four weeks of Day 0;
Show all 26Show fewer
- Patient used any biologic such as alefacept, etanercept, efalizumab, infliximab and adalimumab within 12 weeks of Day 0;
- Patient used ultraviolet light therapy (UVB or nbUVB) within four weeks of Day 0 or PUVA (psoralen ultra violet A) within eight weeks of Day 0;
- Patient with prior or concurrent use of cyclophosphamide;
- Patient with concurrent sulfasalazine therapy or concurrent use of anakinra;
- Patient with an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient.
- Uncontrolled or severe comorbidities such as diabetes mellitus requiring insulin; congestive heart failure (NYHA (New York Heart Association) class III or IV) or history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris; uncontrolled hypertension, oxygen-dependent severe pulmonary disease;
- Patient with a known sero-positivity for HIV (human immunodeficiency virus) or history of any other immunosuppressing disease;
- Patient with active or chronic hepatitis B or C;
- Patient with any active or chronic infection within four weeks before screening or between the screening and baseline visits;
- Patient with any mycobacterial disease, patient with a positive PPD, a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication;
- Patient with a known hypersensitivity to etanercept or one of its components or known to have antibodies to etanercept;
- Patient who received a live attenuated vaccines within 12 weeks of Day 0 or plan to receive one during the study;
- Current pregnancy or lactation;
- At the investigator's discretion, patient with current or history of alcohol or drug abuse that would interfere with the ability of the patient to comply with the study protocol;
- Patient with systemic lupus erythematosus or demyelinating disorder (optic neuritis, multiple sclerosis or other);
- Patient with a history of cancer within five years of Day 0 or presence of cancer except for treated basal or squamous cell carcinoma and in situ cervix carcinoma;
- Patient who failed to respond to nbUVB in the past;
- Patient who have a contra-indication to nbUVB;
- Patient with latex sensitivity (applicable only if they are using prefilled syringe or prefilled SureClickTM autoinjector presentations);
- Patient with a history of non-compliance with other therapies.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Sudbury Skin Clinic
Greater Sudbury, Ontario, P3E 5M4
Innovaderm Research Laval Inc
Laval, Quebec, H7S 2C6
Mediprobe Research inc.
London, Ontario, N5X 2P1
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Lynderm Research Inc.
Markham, Ontario, L3P 1A8
Clinique Dermatologique Fleury
Montreal, Quebec, H2C 1R9
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
Bank on Beauty
Niagara Falls, Ontario, L2E 2R4
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, G1V 4X7
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris
This study will provide data on the addition of narrow band ultra violet B (nbUVB) phototherapy to participants who have not shown an excellent response to three months of etanercept.
Read the detailed description
All participants will receive etanercept 50 mg twice a week for 12 weeks. Participants who reach PASI-90 at Day 84 will be discontinued from the study (they can continue receiving commercial etanercept outside the study). Participants remaining in the study at Day 84 will decrease etanercept to 50 mg weekly for another 12 weeks.
Participants who do not attain a 90 percent reduction in PASI from baseline (PASI-90) after 12 weeks will be randomized (1:1) to receive either etanercept alone or etanercept with short courses of narrow band ultra violet B (nbUVB)phototherapy. Participants randomized to the nbUVB group will receive nbUVB treatments three times a weeks for at least four weeks. At every planned study visit after Day 84, nbUVB treatment will be discontinued in participants who reach PASI-90. nbUVB phototherapy will be re-initiated for another four weeks at the subsequent planned study visit if they lose their PASI-90 response.
Efficacy will be evaluated with PASI, BSA and PGA by a blinded evaluator at Days 0, 28, 84, 112, 140 and 168. The effect of the treatment on quality of life will be evaluated using the DLQI questionnaire at Days 112, 140 and 168. Safety will be evaluated by physical examination and adverse events evaluation.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Etanercept, nbUVB
- Keywords
- Etanercept, UVB, Enbrel, Psoriasis.
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Etanercept 50 mg, subcutaneous (SC) injection.
nbUVBDevice
Also called narrow band ultra violet B phototherapy, narrow band UVB
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Etanercept | Active comparator | All participants received etanercept 50 mg twice a week for 12 weeks. Receives: Drug: Etanercept |
| Part 2 - Etanercept and nbUVB | Active comparator | Participants who did not reach a 90 percent reduction in psoriasis area and severity index (PASI-90) after 12 weeks and were randomized to the narrow band ultra violet B (nbUVB) group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week. Receives: Drug: Etanercept; Device: nbUVB |
| Part 2 - Etanercept | Active comparator | Participants who did not reach PASI-90 after 12 weeks and were randomized to the Etanercept group. They received 50 mg Etanercept once per a week. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 112 and 140 days
Secondary outcomes (18)
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 112, 140 and 168 days
Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 112, 140 and 168 days
Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 28 and 84 days
Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 28 and 84 days
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 28 and 84 days
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 28 and 84 days
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT
Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).
PGA scores are evaluated at each time point.
The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:
- 0 = clear
- 1 = minimal
- 2 = mild
- 3 = moderate
- 4 = severe
- 5 = very severe
The scale evaluates plaque elevation, scaling and erythema.
Measured: 0, 112, 140 and 168 days
Body Surface Area (BSA) Affected by Psoriasis - ITT
BSA scores are evaluated at each time point.
BSA is a measure of the percentage of body surface affected by psoriasis.
Measured: 0, 84, 112, 140 and 168 days
Dermatology Life Quality Index (DLQI) - ITT
The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.
Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.
Scale is from 0 best to 30 worst.
0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life
Measured: 0, 84, 112, 140 and 168 days
Number of Adverse Drug Reactions - ITT
Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of adverse drug reactions.
Definition: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.
Only adverse drug reactions that were at least possibly related to etanercept were recorded. All symptoms observed at the injection site such as erythema, burning, edema and pruritus were recorded together as Injection Site Reaction.
Measured: 196 days
Number of Infectious Adverse Events - ITT
Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of infectious adverse events.
Definition: An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
Only infectious and malignant (including any type of skin cancer) adverse events were recorded.
Measured: 196 days
Number of Serious Adverse Events - ITT
Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of serious adverse events.
Definition: any adverse event from this study that results in one of the following outcomes, or is significant for any other reason:
- death
- initial or prolonged inpatient hospitalization
- a life-threatening experience (that is, immediate risk of dying)
- persistent or significant disability/incapacity
- congenital anomaly/birth defect
Measured: 196 days
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 84, 112, 140 and 168 days
Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 84, 112, 140 and 168 days
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
- 0 = No symptoms
- 1 = Slight
- 2 = Moderate
- 3 = Marked
- 4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst
Measured: 84, 112, 140 and 168 days
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP
Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).
PGA scores are evaluated at each time point.
The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:
- 0 = clear
- 1 = minimal
- 2 = mild
- 3 = moderate
- 4 = severe
- 5 = very severe
The scale evaluates plaque elevation, scaling and erythema.
Measured: 84, 112, 140 and 168 days
Body Surface Area (BSA) Affected by Psoriasis - PP
BSA scores are evaluated at each time point.
BSA is a measure of the percentage of body surface affected by psoriasis.
Measured: 0, 84, 112, 140 and 168 days
Dermatology Life Quality Index (DLQI) - PP
The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.
Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.
Scale is from 0 best to 30 worst.
0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life
Measured: 0, 84, 112, 140 and 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2010
- Study completionMar 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640393
- Sponsor's protocol ID
- Inno-6007
- Status last verified
- Sep 2011
- First submitted
- 18 Mar 2008
- Last updated
- 9 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lynde CW, Gupta AK, Guenther L, Poulin Y, Levesque A, Bissonnette R. A randomized study comparing the combination of nbUVB and etanercept to etanercept monotherapy in patients with psoriasis who do not exhibit an excellent response after 12 weeks of etanercept. J Dermatolog Treat. 2012 Aug;23(4):261-7. doi: 10.3109/09546634.2011.607795. Epub 2011 Aug 10.
PubMed 21797805
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT00640393
- Acronym / sponsor ID
- Inno-6007
- Conditions
- Psoriasis Vulgaris
- Keywords
- Etanercept, UVB, Enbrel, Psoriasis.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Amgen
- Study start
- Apr 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Posted 14 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide data on the addition of narrow band ultra violet B (nbUVB) phototherapy to participants who have not shown an excellent response to three months of etanercept.
Detailed description
All participants will receive etanercept 50 mg twice a week for 12 weeks. Participants who reach PASI-90 at Day 84 will be discontinued from the study (they can continue receiving commercial etanercept outside the study). Participants remaining in the study at Day 84 will decrease etanercept to 50 mg weekly for another 12 weeks.
Participants who do not attain a 90 percent reduction in PASI from baseline (PASI-90) after 12 weeks will be randomized (1:1) to receive either etanercept alone or etanercept with short courses of narrow band ultra violet B (nbUVB)phototherapy. Participants randomized to the nbUVB group will receive nbUVB treatments three times a weeks for at least four weeks. At every planned study visit after Day 84, nbUVB treatment will be discontinued in participants who reach PASI-90. nbUVB phototherapy will be re-initiated for another four weeks at the subsequent planned study visit if they lose their PASI-90 response.
Efficacy will be evaluated with PASI, BSA and PGA by a blinded evaluator at Days 0, 28, 84, 112, 140 and 168. The effect of the treatment on quality of life will be evaluated using the DLQI questionnaire at Days 112, 140 and 168. Safety will be evaluated by physical examination and adverse events evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Etanercept | Active comparator | Drug: EtanerceptAll participants received etanercept 50 mg twice a week for 12 weeks. |
| Part 2 - Etanercept and nbUVB | Active comparator | Drug: Etanercept, Device: nbUVBParticipants who did not reach a 90 percent reduction in psoriasis area and severity index (PASI-90) after 12 weeks and were randomized to the narrow band ultra violet B (nbUVB) group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week. |
| Part 2 - Etanercept | Active comparator | Drug: EtanerceptParticipants who did not reach PASI-90 after 12 weeks and were randomized to the Etanercept group. They received 50 mg Etanercept once per a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older;
- Patient with moderate to severe plaque psoriasis for whom a decision to use etanercept has been made;
- At the investigator discretion, patient who would benefit from systemic therapy;
- PASI (psoriasis area and severity index) ≥ 10 and BSA (body surface area affected by psoriasis) ≥ 10 at day 0;
- Unless surgically sterile (or at least 1 year post-menopausal for women), abstinent or homosexual, patient (men and women) willing to use adequate contraceptive method for at least 30 days before Day 0 and until one month after the last drug administration;
Key exclusion criteria (26 listed)
- Patient used topical steroid, topical tar preparations, or other anti-psoriatic preparations except tar or salicylic acid shampoo or hydrocortisone for the face, scalp, genital and inframammary areas within two weeks of Day 0;
- Patient with presence of erythrodermic, pustular or a predominantly guttate psoriasis;
- At the investigator's discretion, patient with any significant infection within 30 days of screening or a patient at risk of septicemia;
- Patient with evidence of any skin condition that would interfere with the evaluation of psoriasis;
- Patient used investigational drugs within 12 weeks or three half-life of Day 0 whichever is longer;
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 |
|---|---|---|
| EtanerceptAlso: EnbrelEtanercept 50 mg, subcutaneous (SC) injection. | Drug | Part 1 - Etanercept, Part 2 - Etanercept, Part 2 - Etanercept and nbUVB |
| nbUVBAlso: narrow band ultra violet B phototherapy, narrow band UVB | Device | Part 2 - Etanercept and nbUVB |
Primary outcome
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT
Time frame: 112 and 140 days
Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale: * 0 = No symptoms * 1 = Slight * 2 = Moderate * 3 = Marked * 4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6. Total scale 0 = best and 72 = worst
18 secondary outcomes
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT
Time frame: 112, 140 and 168 days
Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT
Time frame: 112, 140 and 168 days
Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT
Time frame: 28 and 84 days
Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT
Time frame: 28 and 84 days
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT
Time frame: 28 and 84 days
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT
Time frame: 28 and 84 days
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT
Time frame: 0, 112, 140 and 168 days
Body Surface Area (BSA) Affected by Psoriasis - ITT
Time frame: 0, 84, 112, 140 and 168 days
Dermatology Life Quality Index (DLQI) - ITT
Time frame: 0, 84, 112, 140 and 168 days
Number of Adverse Drug Reactions - ITT
Time frame: 196 days
Number of Infectious Adverse Events - ITT
Time frame: 196 days
Number of Serious Adverse Events - ITT
Time frame: 196 days
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP
Time frame: 84, 112, 140 and 168 days
Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP
Time frame: 84, 112, 140 and 168 days
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP
Time frame: 84, 112, 140 and 168 days
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP
Time frame: 84, 112, 140 and 168 days
Body Surface Area (BSA) Affected by Psoriasis - PP
Time frame: 0, 84, 112, 140 and 168 days
Dermatology Life Quality Index (DLQI) - PP
Time frame: 0, 84, 112, 140 and 168 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21797805Lynde CW, Gupta AK, Guenther L, Poulin Y, Levesque A, Bissonnette R. A randomized study comparing the combination of nbUVB and etanercept to etanercept monotherapy in patients with psoriasis who do not exhibit an excellent response after 12 weeks of etanercept. J Dermatolog Treat. 2012 Aug;23(4):261-7. doi: 10.3109/09546634.2011.607795. Epub 2011 Aug 10.
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Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
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.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept and nbUVB in people with Psoriasis Vulgaris, run by Innovaderm Research Inc. at 10 sites in Canada.
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 9 inclusion and 26 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 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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 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 14 Dec 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?
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (time frame: 112 and 140 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640393, which also lists 1 linked publication.
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 9 Sep 2011.