A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris
Overview
- Phase
- Phase 4
- Intervention
- Etanercept
- Conditions
- Psoriasis Vulgaris
- Sponsor
- Innovaderm Research Inc.
- Enrollment
- 99
- Locations
- 10
- Primary Endpoint
- Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
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;
Arms & Interventions
Part 1 - Etanercept
All participants received etanercept 50 mg twice a week for 12 weeks.
Intervention: Etanercept
Part 2 - Etanercept and nbUVB
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.
Intervention: Etanercept
Part 2 - Etanercept and nbUVB
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.
Intervention: nbUVB
Part 2 - Etanercept
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.
Intervention: Etanercept
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT(112, 140 and 168 days)
- Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT(112, 140 and 168 days)
- Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT(28 and 84 days)
- Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT(28 and 84 days)
- Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT(28 and 84 days)
- Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT(28 and 84 days)
- Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT(0, 112, 140 and 168 days)
- Body Surface Area (BSA) Affected by Psoriasis - ITT(0, 84, 112, 140 and 168 days)
- Dermatology Life Quality Index (DLQI) - ITT(0, 84, 112, 140 and 168 days)
- Number of Adverse Drug Reactions - ITT(196 days)
- Number of Infectious Adverse Events - ITT(196 days)
- Number of Serious Adverse Events - ITT(196 days)
- Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP(84, 112, 140 and 168 days)
- Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP(84, 112, 140 and 168 days)
- Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP(84, 112, 140 and 168 days)
- Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP(84, 112, 140 and 168 days)
- Body Surface Area (BSA) Affected by Psoriasis - PP(0, 84, 112, 140 and 168 days)
- Dermatology Life Quality Index (DLQI) - PP(0, 84, 112, 140 and 168 days)