- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00566722
Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
Descripción general del estudio
Descripción detallada
This 16-week multicenter, open-label study was designed to evaluate the efficacy and safety of a loading dose of 80 mg adalimumab, followed by 40 mg adalimumab every other week in the treatment of psoriasis in patients with a sub-optimal response to etanercept, methotrexate (MTX), or Narrow band Ultraviolet - B (NB-UVB).
Approximately 150 participants were planned for 3 sub-studies: 80 participants with sub-optimal response to etanercept, 40 participants with sub-optimal response to MTX, and 30 participants with sub-optimal response to NB-UVB. Actual enrollment was 82 participants with sub-optimal response to etanercept, 41 participants with sub-optimal response to MTX, and 29 participants with sub-optimal response to NB-UVB.
Screening was performed at least 96 hours and no more than 31 days before the Baseline visit (Week 0). A participant who was eligible for the study based on sub-optimal response to one treatment (MTX, NB-UVB, or etanercept) was required to discontinue that treatment within a specified time before first dose of adalimumab (see descriptions of sub-study groups). In addition, if the participant was also receiving another qualifying treatment, he/she was required to have discontinued the other treatment at least 30 days before the Baseline visit (Week 0).
Adalimumab was administered by subcutaneous (SC) injection. At the Baseline Visit (Week 0), all participants received an initial dose of 80 mg adalimumab SC. Every other week (odd-numbered weeks) from Week 1 to Week 15, participants received 40 mg adalimumab SC.
This was a single group assignment study, that is, all participants received the same treatment; however, data were summarized for 3 groups (sub-studies) that were defined by psoriasis treatments participants received before entering this study: methotrexate, etanercept, or narrow-band, ultraviolet-B.
Efficacy was evaluated using the Physician's Global Assessment (PGA) of disease severity, and patient-reported outcomes: Patient's Global Assessment (PTGA) of disease severity, the Psoriasis-related Pruritus Assessment, the Dermatology Life Quality Index (DLQI), a visual analog scale (VAS) for plaque psoriasis and psoriatic arthritis pain, the Medical Outcomes Study (MOS) Sleep Scale, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP).
Serious and nonserious adverse events were summarized by sub-study of participants (suboptimal response to MTX, suboptimal response to NB-UVB, and suboptimal response to etanercept).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2S 3B3
- Kirk Barber Research
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Edmonton, Alberta, Canadá, T5K 1X3
- Stratica Medical
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1Z4
- Eastern Canada Cutaneous Research Associates
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Ontario
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Hamilton, Ontario, Canadá, L8N 1V6
- Dermatrials Research
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Waterloo, Ontario, Canadá, N2J 1C4
- K.Papp Clinical Research Inc
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Quebec
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Montreal, Quebec, Canadá
- Siena Medical Research
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Quebec City, Quebec, Canadá, G1V 4X7
- Centre de Rescherche Dermatologique Du Quebec Metropolitain
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Total Skin and Beauty Dermatology Centers
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Dermatology Research of Arkansas
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California
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San Diego, California, Estados Unidos, 92123
- Therapeutics Clinical Research
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Florida
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Miami, Florida, Estados Unidos, 33136
- Florida Academic Dermatology Centers
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Georgia
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Atlanta, Georgia, Estados Unidos, 30327
- Peachtree Dermatology Associates
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46256
- Dawes Fretzin Clinical Research Group
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Massachusetts
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Andover, Massachusetts, Estados Unidos, 01810
- ORA Clinical Research and Development
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New York
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Bronx, New York, Estados Unidos, 10467
- Montifiore Medical Center
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New York, New York, Estados Unidos, 10016
- New York University School of Medicine
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- Paddington Testing Co.
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Rhode Island
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Johnston, Rhode Island, Estados Unidos, 02919
- Clinical Partners
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South Carolina
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Greer, South Carolina, Estados Unidos, 29651
- Radiant Research
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Baylor Research Institute
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Dallas, Texas, Estados Unidos, 75230
- Dermatology Treatment & Research Center, PA Research
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Houston, Texas, Estados Unidos, 77058
- Center for Clinical Studies
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Virginia Clinical Research, Inc.
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Dermatology Associates
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months
- Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy
Exclusion Criteria:
- Prior treatment with adalimumab
- Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet, other systemic psoriasis therapies)
- Prior treatment with natalizumab
- Concurrent active skin diseases/infections
- Poorly controlled medical conditions
- History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
- History of certain cancers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Abierto
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Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0).
From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Periodo de tiempo: Week 16
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The PGA is a 6-point scale used to measure the severity of a patient's disease.
Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).
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Week 16
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Achieving a PGA of Clear (0) at Week 16
Periodo de tiempo: Week 16
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Week 16
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Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
Periodo de tiempo: From Screening to Week 16
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From Screening to Week 16
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Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8
Periodo de tiempo: Weeks 2, 4, and 8
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The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled.
0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.
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Weeks 2, 4, and 8
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Dermatology Life Quality Index (DLQI) Total Score
Periodo de tiempo: From Screening to Week 4 and Week 16
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The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10).
Participants rate how much their skin problem affected their life in previous week.
Responses are 0 (not at all) to 3=very much.
DLQI=total of scores for all items; max=30; min=0.
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From Screening to Week 4 and Week 16
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Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16
Periodo de tiempo: Week 4 and Week 16
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DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.
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Week 4 and Week 16
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Psoriasis-related Pruritus Assessment
Periodo de tiempo: From Screening to Week 16
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The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching).
A decrease in score indicates an improvement in pruritus.
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From Screening to Week 16
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Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis
Periodo de tiempo: From Screening to Week 16
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The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be.
A decrease in score indicates improvement.
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From Screening to Week 16
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Percent Work Time Missed Due to Psoriasis
Periodo de tiempo: From Screening to Week 16
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Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work.
It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities.
Decreases in values on each part indicate improvement.
At Screening, percent time missed in the previous week ranged from 0% to 40%.
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From Screening to Week 16
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Percent Overall Work Impairment Due to Psoriasis
Periodo de tiempo: From Screening to Week 16
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Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above).
At Screening, overall impairment ranged from 0% to 94%.
A decrease in percent overall work impairment indicates improvement.
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From Screening to Week 16
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Percent Impairment While Working Due to Psoriasis
Periodo de tiempo: From Screening to Week 16
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Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above.
At Screening, impairment while working ranged from 0% to 90%.
A decrease in percent impairment indicates improvement.
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From Screening to Week 16
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Percent Activity Impairment Due to Psoriasis
Periodo de tiempo: From Screening to Week 16
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Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above.
At Screening, activity impairment due to psoriasis ranged from 0% to 90%.
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From Screening to Week 16
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Sleep Problems Index II
Periodo de tiempo: From Screening to Week 16
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Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache.
Participant rates each item from "none of the time" to "all of the time" for the previous 4 weeks.
Scores are transformed to 0 to 100 scale; lower scores indicate less impairment.
Decrease in score indicates improvement.
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From Screening to Week 16
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Martin M Okun, M.D., Ph.D., Abbott
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M10-238
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Soriasis
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ProgenaBiomeReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Rostro de psoriasis | Clavo de la psoriasis | Psoriasis difusa | Psoriasis Punctata | Psoriasis palmar | Psoriasis circinata | Psoriasis anular | Psoriasis genital | Psoriasis GeográficaEstados Unidos
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Centre of Evidence of the French Society of DermatologyReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Psoriasis palmar | Eritrodermia psoriásica | Uña psoriásica | Psoriasis en gotas | Psoriasis inversa | Psoriasis pustulosaFrancia
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Clin4allReclutamientoPsoriasis del cuero cabelludo | Clavo de la psoriasis | Psoriasis palmar | Psoriasis genital | Psoriasis plantarFrancia
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Herlev and Gentofte HospitalReclutamientoInfarto de miocardio | Isquemia miocardica | Enfermedades cardíacas | Enfermedades cardiovasculares | Insuficiencia cardiaca | Carrera | Soriasis | Insuficiencia Cardíaca Diastólica | Psoriasis vulgar | Factor de riesgo cardiovascular | Insuficiencia Cardíaca Sistólica | Disfunción Ventricular Izquierda | Psoriasis... y otras condicionesDinamarca
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UCB Biopharma S.P.R.L.TerminadoPsoriasis moderada a severa | Psoriasis Pustular Generalizada y Psoriasis EritrodérmicaJapón
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Innovaderm Research Inc.TerminadoPsoriasis del cuero cabelludo | Psoriasis pustulosa palmo-plantar | Psoriasis palmoplantar no pustulosa | Psoriasis de codo | Psoriasis de la parte inferior de la piernaCanadá
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AmgenTerminadoPsoriasis tipo psoriasis | Psoriasis tipo placaEstados Unidos
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TakedaReclutamientoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
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Janssen Pharmaceutical K.K.ReclutamientoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
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Eli Lilly and CompanyTerminadoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
Ensayos clínicos sobre adalimumab
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PfizerTerminadoSaludableEstados Unidos, Bélgica
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PfizerTerminado
-
AbbottTerminadoArtritis Idiopática JuvenilEstados Unidos, Bélgica, República Checa, Francia, Alemania, Italia, Eslovaquia, España
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Mylan Inc.Mylan GmbHTerminadoSoriasis | Artritis, PsoriásicaBulgaria, Estonia, Hungría, Polonia, Federación Rusa, Ucrania
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AbbottTerminadoArtritis ReumatoideEspaña
-
AbbottTerminadoEnfermedad de CrohnEstados Unidos
-
AbbVie (prior sponsor, Abbott)TerminadoArtritis ReumatoideEstados Unidos
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AbbVie (prior sponsor, Abbott)TerminadoArtritis ReumatoideEstados Unidos, Bélgica, República Checa, Alemania, Puerto Rico, Rumania, Eslovaquia
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Shanghai Henlius BiotechTerminadoTrastorno del sistema inmunológicoPorcelana