Safety and Efficacy of Combining nbUVB to Etanercept in Patients

NCT00640393 | Completed Phase 4 Results

• 1 other identifier: Inno-6007
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 10

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.

Conditions

Psoriasis Vulgaris

Keywords

Etanercept, UVB, Enbrel, Psoriasis.

Outcome Measures

Primary Outcomes (1)

• 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

  112 and 140 days

Secondary Outcomes (18)

• 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

Study Arms (3)

Part 1 - Etanercept

ACTIVE COMPARATOR

All participants received etanercept 50 mg twice a week for 12 weeks.

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.

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.

Drug: Etanercept

Interventions

Etanercept DRUG

Etanercept 50 mg, subcutaneous (SC) injection.

Also known as: Enbrel

Part 1 - Etanercept; Part 2 - Etanercept; Part 2 - Etanercept and nbUVB

nbUVB DEVICE

Also known as: narrow band ultra violet B phototherapy, narrow band UVB

Part 2 - Etanercept and nbUVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Amgen: collaborator

Study Sites (10)

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Sudbury Skin Clinic

Greater Sudbury, Ontario, P3E 5M4, Canada

Location

Mediprobe Research inc.

London, Ontario, N5X 2P1, Canada

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

Bank on Beauty

Niagara Falls, Ontario, L2E 2R4, Canada

Location

Innovaderm Research Laval Inc

Laval, Quebec, H7S 2C6, Canada

Location

Clinique Dermatologique Fleury

Montreal, Quebec, H2C 1R9, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Related Publications (1)

• 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.

  PMID: 21797805 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Annie Levesque
• Organization: Innovaderm Research Inc

alevesque@innovaderm.ca

514-521-4285

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 9, 2011
• Results First Posted: December 14, 2010

Record last verified: 2011-09

Locations

CA (10)