A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
1 de agosto de 2012 actualizado por: Abbott
A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis
To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX).
Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase.
All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease.
Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment.
Participants who completed the 26 weeks of treatment (either double-blind study drug [adalimumab or placebo] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow.
Efficacy and safety assessments were performed at Baseline and at designated study visits.
Tipo de estudio
Intervencionista
Inscripción (Actual)
334
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Anjo, Japón
- Site Reference ID/Investigator# 46861
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Aomori, Japón
- Site Reference ID/Investigator# 46919
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Chiba, Japón
- Site Reference ID/Investigator# 46805
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Chiba, Japón
- Site Reference ID/Investigator# 46806
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Chiba, Japón
- Site Reference ID/Investigator# 46880
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Chiba, Japón
- Site Reference ID/Investigator# 46881
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Fuchu, Japón
- Site Reference ID/Investigator# 46890
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Fukuoka, Japón
- Site Reference ID/Investigator# 46902
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Fukuoka, Japón
- Site Reference ID/Investigator# 46903
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Fukuoka, Japón
- Site Reference ID/Investigator# 46904
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Gifu, Japón
- Site Reference ID/Investigator# 46856
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Gunma, Japón
- Site Reference ID/Investigator# 46944
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Hiroshima, Japón
- Site Reference ID/Investigator# 46893
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Hiroshima, Japón
- Site Reference ID/Investigator# 46894
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Hokkaido, Japón
- Site Reference ID/Investigator# 12161
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Hokkaido, Japón
- Site Reference ID/Investigator# 46916
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Hokkaido, Japón
- Site Reference ID/Investigator# 46918
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Hyogo, Japón
- Site Reference ID/Investigator# 46865
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Hyogo, Japón
- Site Reference ID/Investigator# 46871
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Ibaraki, Japón
- Site Reference ID/Investigator# 46801
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Ibaraki, Japón
- Site Reference ID/Investigator# 46925
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Iwate, Japón
- Site Reference ID/Investigator# 46800
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Kagoshima, Japón
- Site Reference ID/Investigator# 46873
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Kagoshima, Japón
- Site Reference ID/Investigator# 46874
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Kanagawa, Japón
- Site Reference ID/Investigator# 46845
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Kanagawa, Japón
- Site Reference ID/Investigator# 46899
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Kanagawa, Japón
- Site Reference ID/Investigator# 46901
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Kanazawa, Japón
- Site Reference ID/Investigator# 46851
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Kanazawa, Japón
- Site Reference ID/Investigator# 46852
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Kawagoe, Japón
- Site Reference ID/Investigator# 46802
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Kawasaki, Japón
- Site Reference ID/Investigator# 46900
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Kirishima, Japón
- Site Reference ID/Investigator# 46875
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Kitakyushu, Japón
- Site Reference ID/Investigator# 46870
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Kumamoto, Japón
- Site Reference ID/Investigator# 46872
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Kumamoto, Japón
- Site Reference ID/Investigator# 46912
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Kyoto, Japón
- Site Reference ID/Investigator# 46864
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Maebashi, Japón
- Site Reference ID/Investigator# 46943
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Matsuyama, Japón
- Site Reference ID/Investigator# 46898
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Miyazaki, Japón
- Site Reference ID/Investigator# 46915
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Nagano, Japón
- Site Reference ID/Investigator# 46853
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Nagano, Japón
- Site Reference ID/Investigator# 46855
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Nagasaki, Japón
- Site Reference ID/Investigator# 46909
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Nagasaki, Japón
- Site Reference ID/Investigator# 46910
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Nagasaki, Japón
- Site Reference ID/Investigator# 46911
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Nagoya, Japón
- Site Reference ID/Investigator# 46858
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Nagoya, Japón
- Site Reference ID/Investigator# 46860
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Nara, Japón
- Site Reference ID/Investigator# 46877
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Nara, Japón
- Site Reference ID/Investigator# 46885
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Niigata, Japón
- Site Reference ID/Investigator# 46848
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Niigata, Japón
- Site Reference ID/Investigator# 46906
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Oita, Japón
- Site Reference ID/Investigator# 46914
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Okayama, Japón
- Site Reference ID/Investigator# 46869
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Okayama, Japón
- Site Reference ID/Investigator# 46886
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Okayama, Japón
- Site Reference ID/Investigator# 46887
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Okayama, Japón
- Site Reference ID/Investigator# 46892
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Okinawa, Japón
- Site Reference ID/Investigator# 46876
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Osaka, Japón
- Site Reference ID/Investigator# 46946
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Osaka, Japón
- Site Reference ID/Investigator# 46947
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Rifu, Japón
- Site Reference ID/Investigator# 46842
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Sagamihara, Japón
- Site Reference ID/Investigator# 46846
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Saitama, Japón
- Site Reference ID/Investigator# 46803
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Saitama, Japón
- Site Reference ID/Investigator# 46804
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Saitama, Japón
- Site Reference ID/Investigator# 46878
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Saitama, Japón
- Site Reference ID/Investigator# 46879
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Sapporo, Japón
- Site Reference ID/Investigator# 46917
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Shimotsuke, Japón
- Site Reference ID/Investigator# 46942
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Shizuoka, Japón
- Site Reference ID/Investigator# 46854
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Shizuoka, Japón
- Site Reference ID/Investigator# 46857
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Shizuoka, Japón
- Site Reference ID/Investigator# 46859
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Takamatsu, Japón
- Site Reference ID/Investigator# 46895
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Tokyo, Japón
- Site Reference ID/Investigator# 46843
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Tokyo, Japón
- Site Reference ID/Investigator# 46844
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Tokyo, Japón
- Site Reference ID/Investigator# 46850
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Tokyo, Japón
- Site Reference ID/Investigator# 46882
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Tokyo, Japón
- Site Reference ID/Investigator# 46883
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Tokyo, Japón
- Site Reference ID/Investigator# 46884
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Tokyo, Japón
- Site Reference ID/Investigator# 46888
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Tokyo, Japón
- Site Reference ID/Investigator# 46889
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Tokyo, Japón
- Site Reference ID/Investigator# 46891
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Tokyo, Japón
- Site Reference ID/Investigator# 46896
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Toyama, Japón
- Site Reference ID/Investigator# 46849
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Toyama, Japón
- Site Reference ID/Investigator# 46907
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Toyoake, Japón
- Site Reference ID/Investigator# 46862
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Toyohashi, Japón
- Site Reference ID/Investigator# 46866
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Tsu, Japón
- Site Reference ID/Investigator# 46863
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Tsukuba, Japón
- Site Reference ID/Investigator# 46926
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Yokohama, Japón
- Site Reference ID/Investigator# 46897
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Yokohama, Japón
- Site Reference ID/Investigator# 46905
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria
- Rheumatoid arthritis based on the American College of Rheumatology criteria
- Methotrexate or leflunomide naïve
- Disease duration less than or equal to 2 years from diagnosis
Exclusion Criteria
- History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
- Joint surgery involving joints to be assessed within 8 weeks prior to Screening
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: DB Placebo
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks.
Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
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Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Otros nombres:
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Experimental: DB adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks.
Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
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Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Otros nombres:
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Experimental: DB Adalimumab/OL Adalimumab
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks.
Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
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Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Otros nombres:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Otros nombres:
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Experimental: DB Placebo/OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks.
Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
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Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Otros nombres:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Otros nombres:
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Experimental: DB Adalimumab/RE OL Adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks.
Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
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Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Otros nombres:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Otros nombres:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
Otros nombres:
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Experimental: DB Placebo/RE OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks.
Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
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Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Otros nombres:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Otros nombres:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
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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Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Periodo de tiempo: Baseline, Week 26
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Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease.
Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]).
Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]).
Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
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Baseline, Week 26
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Periodo de tiempo: Week 26
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Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein.
Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
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Week 26
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Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Periodo de tiempo: Week 26
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Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein.
Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
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Week 26
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Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Periodo de tiempo: Week 26
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Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein.
Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
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Week 26
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Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
Periodo de tiempo: Baseline, Week 26
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Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis.
Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate.
DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
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Baseline, Week 26
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Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
Periodo de tiempo: Week 26
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Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis.
Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate.
DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
DAS28(ESR) score <2.6 was defined as clinical remission of disease.
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Week 26
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Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
Periodo de tiempo: Through Week 26
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Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug.
The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized.
See the Reported Adverse Event section for details.
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Through Week 26
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Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
Periodo de tiempo: Baseline, Week 52
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Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease.
Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]).
Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]).
Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.
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Baseline, Week 52
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Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Periodo de tiempo: Week 52
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Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
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Week 52
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Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Periodo de tiempo: Week 52
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Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
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Week 52
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Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Periodo de tiempo: Week 52
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Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
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Week 52
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Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
Periodo de tiempo: Baseline, Week 52
|
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis.
Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate.
DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
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Baseline, Week 52
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Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
Periodo de tiempo: Week 52
|
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis.
Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate.
DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
DAS28(ESR) score <2.6 was defined as clinical remission of disease.
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Week 52
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Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
Periodo de tiempo: Through Week 52
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Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab.
The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized.
See the Reported Adverse Event section for details.
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Through Week 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
- Yamanaka H, Ishiguro N, Takeuchi T, Miyasaka N, Mukai M, Matsubara T, Uchida S, Akama H, Kupper H, Arora V, Tanaka Y. Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial. Rheumatology (Oxford). 2014 May;53(5):904-13. doi: 10.1093/rheumatology/ket465. Epub 2014 Jan 17.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2009
Finalización primaria (Actual)
1 de marzo de 2011
Finalización del estudio (Actual)
1 de agosto de 2011
Fechas de registro del estudio
Enviado por primera vez
26 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
26 de marzo de 2009
Publicado por primera vez (Estimar)
27 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de agosto de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
1 de agosto de 2012
Última verificación
1 de agosto de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M06-859
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. .