Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Safety and Efficacy of Combining nbUVB to Etanercept in Patients

1 settembre 2011 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

99

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Part 1 - Etanercept
All participants received etanercept 50 mg twice a week for 12 weeks.
Droga: Etanercept
Etanercept 50 mg, subcutaneous (SC) injection.
Altri nomi:
  • Enbrel
Comparatore attivo: 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.
Droga: Etanercept
Etanercept 50 mg, subcutaneous (SC) injection.
Altri nomi:
  • Enbrel
Dispositivo: nbUVB
Altri nomi:
  • narrow band ultra violet B phototherapy
  • UVB a banda stretta
Comparatore attivo: 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.
Droga: Etanercept
Etanercept 50 mg, subcutaneous (SC) injection.
Altri nomi:
  • Enbrel

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Innovaderm Research Inc.

Collaboratori

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2008

Completamento primario (Effettivo)

1 febbraio 2010

Completamento dello studio (Effettivo)

1 marzo 2010

Date di iscrizione allo studio

Primo inviato

18 marzo 2008

Primo inviato che soddisfa i criteri di controllo qualità

20 marzo 2008

Primo Inserito (Stima)

21 marzo 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

9 settembre 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 settembre 2011

Ultimo verificato

1 settembre 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Inno-6007

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Psoriasi volgare

Prove cliniche su Etanercept

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Congo, DR of

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi