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Safety and Efficacy of Combining nbUVB to Etanercept in Patients
This study is ongoing, but not recruiting participants.
First Received: March 18, 2008   Last Updated: August 25, 2009   History of Changes
Sponsors and Collaborators: Innovaderm Research Inc.
Amgen
Information provided by: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT00640393
  Purpose

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.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: Etanercept 50 mg
Device: nbUVB
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by Innovaderm Research Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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; [ Time Frame: 16 and 20 weeks ] [ Designated as safety issue: No ]
  • 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; [ Time Frame: 16, 20 and 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients enrolled reaching PASI-50, PASI-75, PASI-90 and PASI-100 at Days 28 and 84 (weeks 4 and 12) [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 16, 20 and 24 weeks ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 16, 20 and 24 weeks ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 16, 20 and 24 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 98
Study Start Date: April 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Etanercept: Active Comparator
Etanercept 50 mg Alone once a week.
Drug: Etanercept 50 mg
All patients will receive Etanercept from Day 0 until Day 84. Patients who do not reach PASI 90 will be randomized to etanercept 50mg weekly.
Etanercept and nbUVB: Active Comparator
Patients randomized to the nbUVB group will receive nbUVB treatments three times a week and 50 mg Etanercept once per week.
Drug: Etanercept 50 mg
All patients will receive Etanercept from Day 0 until Day 84. Patients who do not reach PASI 90 will be randomized to etanercept 50mg weekly and nbUVB treatments three times a week.
Device: nbUVB
All patients will receive Etanercept from Day 0 until Day 84. Patients who do not reach PASI 90 will be randomized to etanercept 50mg weekly and nbUVB treatments three times a week.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640393

Locations
Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Quebec, Canada, G1V 4X7
Canada, British Columbia
PerCuro Clinical research Ltd.
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Ontario
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1A8
Bank on Beauty
Niagara Falls, Ontario, Canada, L2E 2R4
Mediprobe Research inc.
London, Ontario, Canada, N5X 2P1
Sudbury Skin Clinic
Sudbury, Ontario, Canada, P3E 5M4
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7
Canada, Quebec
Innovaderm Research Inc
Laval, Quebec, Canada, H7S 2C6
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Clinique Dermatologique Fleury
Montreal, Quebec, Canada, H2C 1R9
Sponsors and Collaborators
Innovaderm Research Inc.
Amgen
Investigators
Principal Investigator: Robert Bissonnette, MD Innovaderm Research Inc.
  More Information

No publications provided

Responsible Party: Innovaderm Research Inc ( Robert Bissonnette )
Study ID Numbers: Inno-6007
Study First Received: March 18, 2008
Last Updated: August 25, 2009
ClinicalTrials.gov Identifier: NCT00640393     History of Changes
Health Authority: Canada: Ethics Review Committee

Keywords provided by Innovaderm Research Inc.:
Etanercept, UVB, Enbrel, Psoriasis.

Study placed in the following topic categories:
Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Analgesics, Non-Narcotic
Psoriasis
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 10, 2009