Safety and Efficacy of Combining nbUVB to Etanercept in Patients

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Etanercept (Drug); nbUVB (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Innovaderm Research Inc.

Official(s) and/or principal investigator(s):
Robert Bissonnette, MD, Principal Investigator, Affiliation: Innovaderm Research Inc.

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.

Official title: A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT

Secondary outcome:

Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT

Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT

Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT

Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT

Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT

Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT

Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT

Body Surface Area (BSA) Affected by Psoriasis - ITT

Dermatology Life Quality Index (DLQI) - ITT

Number of Adverse Drug Reactions - ITT

Number of Infectious Adverse Events - ITT

Number of Serious Adverse Events - ITT

Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP

Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP

Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP

Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP

Body Surface Area (BSA) Affected by Psoriasis - PP

Dermatology Life Quality Index (DLQI) - PP

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Centre de Recherche Dermatologique du Quebec Metropolitain, Quebec G1V 4X7, Canada

Winnipeg Clinic, Winnipeg, Manitoba R3C 0N2, Canada

Mediprobe Research inc., London, Ontario N5X 2P1, Canada

The Guenther Dermatology Research Centre, London, Ontario N6A 3H7, Canada

Lynderm Research Inc., Markham, Ontario L3P 1A8, Canada

Bank on Beauty, Niagara Falls, Ontario L2E 2R4, Canada

Sudbury Skin Clinic, Sudbury, Ontario P3E 5M4, Canada

Innovaderm Research Laval Inc, Laval, Quebec H7S 2C6, Canada

Clinique Dermatologique Fleury, Montreal, Quebec H2C 1R9, Canada

Innovaderm Research Inc., Montreal, Quebec H2K 4L5, Canada

Starting date: April 2008
Last updated: September 1, 2011