Clinical trial NCT00640393: Safety and Efficacy of Combining nbUVB to Etanercept in Patients
Official title: A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Keywords: Etanercept, UVB, Enbrel, Psoriasis.
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-03-21
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;
* 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

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT
timeFrame: 112 and 140 days
Secondary outcomes:
measure: Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT
timeFrame: 112, 140 and 168 days
measure: Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT
timeFrame: 112, 140 and 168 days
measure: Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT
timeFrame: 28 and 84 days
measure: Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT
timeFrame: 28 and 84 days
measure: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT
timeFrame: 28 and 84 days
measure: Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT
timeFrame: 28 and 84 days
measure: Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT
timeFrame: 0, 112, 140 and 168 days
measure: Body Surface Area (BSA) Affected by Psoriasis - ITT
timeFrame: 0, 84, 112, 140 and 168 days
measure: Dermatology Life Quality Index (DLQI) - ITT
timeFrame: 0, 84, 112, 140 and 168 days
measure: Number of Adverse Drug Reactions - ITT
timeFrame: 196 days
measure: Number of Infectious Adverse Events - ITT
timeFrame: 196 days
measure: Number of Serious Adverse Events - ITT
timeFrame: 196 days
measure: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP
timeFrame: 84, 112, 140 and 168 days
measure: Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP
timeFrame: 84, 112, 140 and 168 days
measure: Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP
timeFrame: 84, 112, 140 and 168 days
measure: Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP
timeFrame: 84, 112, 140 and 168 days
measure: Body Surface Area (BSA) Affected by Psoriasis - PP
timeFrame: 0, 84, 112, 140 and 168 days
measure: Dermatology Life Quality Index (DLQI) - PP
timeFrame: 0, 84, 112, 140 and 168 days
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: London
country: Canada
facility: Mediprobe Research inc.
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Niagara Falls
country: Canada
facility: Bank on Beauty
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinic
state: Ontario
city: Laval
country: Canada
facility: Innovaderm Research Laval Inc
state: Quebec
city: Montreal
country: Canada
facility: Clinique Dermatologique Fleury
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.