Safety and Efficacy of Combining nbUVB to Etanercept in Patients

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Etanercept 50 mg (Drug); Etanercept 50 mg (Drug); nbUVB (Device)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Innovaderm Research Inc.

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

Overall contact:
Pierre Lebeau, Phone: (514) 521-3111, Ext: 233

This study will provide data on the addition of nbUVB phototherapy to patients 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: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number of patients treated with etanercept and nbUVB reaching PASI-90 at Day 168 (week 24) as compared to number patients treated with etanercept alone.

Secondary outcome:

Number of patients treated with etanercept and nbUVB reaching PASI-90 at Days 112 and 140 (weeks 16 and 20) as compared to number of patients treated with etanercept alone;

Number of patients treated with etanercept and nbUVB reaching PASI-75 and PASI-100 at Days 112, 140 and 168 (weeks 16, 20 and 24) as compared to number of patients treated with etanercept alone;

Number of patients enrolled reaching PASI-50, PASI-75, PASI-90 and PASI-100 at Days 28 and 84 (weeks 4 and 12)

Efficacy of etanercept and nbUVB as compared to etanercept alone to improve psoriasis vulgaris as measured with the PGA (Physician's Global Assessment) at Days 112, 140 and 168 (weeks 16, 20 and 24)

Efficacy of etanercept and nbUVB as compared to etanercept alone to improve psoriasis vulgaris as measured with the BSA (Body Surface Area) at Days 112, 140 and 168 (weeks 16, 20 and 24).

Efficacy of etanercept and nbUVB as compared to etanercept alone to improve the quality of life of patients with psoriasis vulgaris as measured with the DLQI (Dermatology Life Quality Index) at Days 112, 140 and 168 (weeks 16, 20 and 24).

Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of adverse drug reactions, infectious adverse events and serious adverse events.

Detailed description: All patients will receive etanercept 50 mg twice a week for 12 weeks. Patients who reach PASI-90 at Day 84 will be discontinued from the study (they can continue receiving commercial etanercept outside the study). Patients remaining in the study at Day 84 will decrease etanercept to 50 mg weekly for another 12 weeks.

Patients who do not reach PASI-90 after 12 weeks will be randomized (1: 1) to receive either etanercept alone or etanercept with short courses of nbUVB. Patients 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 patients who reach PASI-90. nbUVB phototherapy will be re-initiated for another four weeks at the following 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 (insurance coverage, if applicable, needs to be determined before screening);

- At the investigator discretion, patient who would benefit from systemic therapy;

- PASI ≥ 10 and BSA ≥ 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 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 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 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 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.

Pierre Lebeau, Phone: (514) 521-3111, Ext: 233

Innovaderm Research Inc, Laval, Quebec, Canada

Starting date: April 2008
Ending date: August 2009
Last updated: March 20, 2008