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Safety and Efficacy of Combining nbUVB to Etanercept in Patients

1. září 2011 aktualizováno: Innovaderm Research Inc.

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

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

99

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
      • Quebec, Kanada, G1V 4X7
        • Centre De Recherche Dermatologique Du Quebec Metropolitain
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3C 0N2
        • Winnipeg Clinic
    • Ontario
      • London, Ontario, Kanada, N6A 3H7
        • The Guenther Dermatology Research Centre
      • London, Ontario, Kanada, N5X 2P1
        • Mediprobe Research Inc.
      • Markham, Ontario, Kanada, L3P 1A8
        • Lynderm Research Inc.
      • Niagara Falls, Ontario, Kanada, L2E 2R4
        • Bank on Beauty
      • Sudbury, Ontario, Kanada, P3E 5M4
        • Sudbury Skin Clinic
    • Quebec
      • Laval, Quebec, Kanada, H7S 2C6
        • Innovaderm Research Laval Inc
      • Montreal, Quebec, Kanada, H2K 4L5
        • Innovaderm Research Inc.
      • Montreal, Quebec, Kanada, H2C 1R9
        • Clinique Dermatologique Fleury

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Part 1 - Etanercept
All participants received etanercept 50 mg twice a week for 12 weeks.
Lék: Etanercept
Etanercept 50 mg, subcutaneous (SC) injection.
Ostatní jména:
  • Enbrel
Aktivní komparátor: 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.
Lék: Etanercept
Etanercept 50 mg, subcutaneous (SC) injection.
Ostatní jména:
  • Enbrel
Přístroj: nbUVB
Ostatní jména:
  • narrow band ultra violet B phototherapy
  • úzké pásmo UVB
Aktivní komparátor: 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.
Lék: Etanercept
Etanercept 50 mg, subcutaneous (SC) injection.
Ostatní jména:
  • Enbrel

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT
Časové okno: 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
112 and 140 days

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT
Časové okno: 112, 140 and 168 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
112, 140 and 168 days
Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT
Časové okno: 112, 140 and 168 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
112, 140 and 168 days
Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT
Časové okno: 28 and 84 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
28 and 84 days
Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT
Časové okno: 28 and 84 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
28 and 84 days
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT
Časové okno: 28 and 84 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
28 and 84 days
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT
Časové okno: 28 and 84 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
28 and 84 days
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT
Časové okno: 0, 112, 140 and 168 days

Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).

PGA scores are evaluated at each time point.

The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:

  • 0 = clear
  • 1 = minimal
  • 2 = mild
  • 3 = moderate
  • 4 = severe
  • 5 = very severe

The scale evaluates plaque elevation, scaling and erythema.
0, 112, 140 and 168 days
Body Surface Area (BSA) Affected by Psoriasis - ITT
Časové okno: 0, 84, 112, 140 and 168 days

BSA scores are evaluated at each time point.

BSA is a measure of the percentage of body surface affected by psoriasis.
0, 84, 112, 140 and 168 days
Dermatology Life Quality Index (DLQI) - ITT
Časové okno: 0, 84, 112, 140 and 168 days

The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.

Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.

Scale is from 0 best to 30 worst.

0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life
0, 84, 112, 140 and 168 days
Number of Adverse Drug Reactions - ITT
Časové okno: 196 days

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

Definition: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.

Only adverse drug reactions that were at least possibly related to etanercept were recorded. All symptoms observed at the injection site such as erythema, burning, edema and pruritus were recorded together as Injection Site Reaction.
196 days
Number of Infectious Adverse Events - ITT
Časové okno: 196 days

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

Definition: An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.

Only infectious and malignant (including any type of skin cancer) adverse events were recorded.
196 days
Number of Serious Adverse Events - ITT
Časové okno: 196 days

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

Definition: any adverse event from this study that results in one of the following outcomes, or is significant for any other reason:

  • death
  • initial or prolonged inpatient hospitalization
  • a life-threatening experience (that is, immediate risk of dying)
  • persistent or significant disability/incapacity
  • congenital anomaly/birth defect
196 days
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP
Časové okno: 84, 112, 140 and 168 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
84, 112, 140 and 168 days
Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP
Časové okno: 84, 112, 140 and 168 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
84, 112, 140 and 168 days
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP
Časové okno: 84, 112, 140 and 168 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
84, 112, 140 and 168 days
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP
Časové okno: 84, 112, 140 and 168 days

Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).

PGA scores are evaluated at each time point.

The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:

  • 0 = clear
  • 1 = minimal
  • 2 = mild
  • 3 = moderate
  • 4 = severe
  • 5 = very severe

The scale evaluates plaque elevation, scaling and erythema.
84, 112, 140 and 168 days
Body Surface Area (BSA) Affected by Psoriasis - PP
Časové okno: 0, 84, 112, 140 and 168 days

BSA scores are evaluated at each time point.

BSA is a measure of the percentage of body surface affected by psoriasis.
0, 84, 112, 140 and 168 days
Dermatology Life Quality Index (DLQI) - PP
Časové okno: 0, 84, 112, 140 and 168 days

The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.

Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.

Scale is from 0 best to 30 worst.

0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life
0, 84, 112, 140 and 168 days

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Innovaderm Research Inc.

Spolupracovníci

Amgen

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2008

Primární dokončení (Aktuální)

1. února 2010

Dokončení studie (Aktuální)

1. března 2010

Termíny zápisu do studia

První předloženo

18. března 2008

První předloženo, které splnilo kritéria kontroly kvality

20. března 2008

První zveřejněno (Odhad)

21. března 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

9. září 2011

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. září 2011

Naposledy ověřeno

1. září 2011

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Inno-6007

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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