A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
1 de agosto de 2012 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
334
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Anjo, Japão
- Site Reference ID/Investigator# 46861
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Aomori, Japão
- Site Reference ID/Investigator# 46919
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Chiba, Japão
- Site Reference ID/Investigator# 46805
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Chiba, Japão
- Site Reference ID/Investigator# 46806
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Chiba, Japão
- Site Reference ID/Investigator# 46880
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Chiba, Japão
- Site Reference ID/Investigator# 46881
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Fuchu, Japão
- Site Reference ID/Investigator# 46890
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Fukuoka, Japão
- Site Reference ID/Investigator# 46902
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Fukuoka, Japão
- Site Reference ID/Investigator# 46903
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Fukuoka, Japão
- Site Reference ID/Investigator# 46904
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Gifu, Japão
- Site Reference ID/Investigator# 46856
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Gunma, Japão
- Site Reference ID/Investigator# 46944
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Hiroshima, Japão
- Site Reference ID/Investigator# 46893
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Hiroshima, Japão
- Site Reference ID/Investigator# 46894
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Hokkaido, Japão
- Site Reference ID/Investigator# 12161
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Hokkaido, Japão
- Site Reference ID/Investigator# 46916
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Hokkaido, Japão
- Site Reference ID/Investigator# 46918
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Hyogo, Japão
- Site Reference ID/Investigator# 46865
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Hyogo, Japão
- Site Reference ID/Investigator# 46871
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Ibaraki, Japão
- Site Reference ID/Investigator# 46801
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Ibaraki, Japão
- Site Reference ID/Investigator# 46925
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Iwate, Japão
- Site Reference ID/Investigator# 46800
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Kagoshima, Japão
- Site Reference ID/Investigator# 46873
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Kagoshima, Japão
- Site Reference ID/Investigator# 46874
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Kanagawa, Japão
- Site Reference ID/Investigator# 46845
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Kanagawa, Japão
- Site Reference ID/Investigator# 46899
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Kanagawa, Japão
- Site Reference ID/Investigator# 46901
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Kanazawa, Japão
- Site Reference ID/Investigator# 46851
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Kanazawa, Japão
- Site Reference ID/Investigator# 46852
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Kawagoe, Japão
- Site Reference ID/Investigator# 46802
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Kawasaki, Japão
- Site Reference ID/Investigator# 46900
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Kirishima, Japão
- Site Reference ID/Investigator# 46875
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Kitakyushu, Japão
- Site Reference ID/Investigator# 46870
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Kumamoto, Japão
- Site Reference ID/Investigator# 46872
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Kumamoto, Japão
- Site Reference ID/Investigator# 46912
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Kyoto, Japão
- Site Reference ID/Investigator# 46864
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Maebashi, Japão
- Site Reference ID/Investigator# 46943
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Matsuyama, Japão
- Site Reference ID/Investigator# 46898
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Miyazaki, Japão
- Site Reference ID/Investigator# 46915
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Nagano, Japão
- Site Reference ID/Investigator# 46853
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Nagano, Japão
- Site Reference ID/Investigator# 46855
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Nagasaki, Japão
- Site Reference ID/Investigator# 46909
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Nagasaki, Japão
- Site Reference ID/Investigator# 46910
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Nagasaki, Japão
- Site Reference ID/Investigator# 46911
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Nagoya, Japão
- Site Reference ID/Investigator# 46858
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Nagoya, Japão
- Site Reference ID/Investigator# 46860
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Nara, Japão
- Site Reference ID/Investigator# 46877
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Nara, Japão
- Site Reference ID/Investigator# 46885
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Niigata, Japão
- Site Reference ID/Investigator# 46848
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Niigata, Japão
- Site Reference ID/Investigator# 46906
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Oita, Japão
- Site Reference ID/Investigator# 46914
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Okayama, Japão
- Site Reference ID/Investigator# 46869
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Okayama, Japão
- Site Reference ID/Investigator# 46886
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Okayama, Japão
- Site Reference ID/Investigator# 46887
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Okayama, Japão
- Site Reference ID/Investigator# 46892
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Okinawa, Japão
- Site Reference ID/Investigator# 46876
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Osaka, Japão
- Site Reference ID/Investigator# 46946
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Osaka, Japão
- Site Reference ID/Investigator# 46947
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Rifu, Japão
- Site Reference ID/Investigator# 46842
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Sagamihara, Japão
- Site Reference ID/Investigator# 46846
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Saitama, Japão
- Site Reference ID/Investigator# 46803
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Saitama, Japão
- Site Reference ID/Investigator# 46804
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Saitama, Japão
- Site Reference ID/Investigator# 46878
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Saitama, Japão
- Site Reference ID/Investigator# 46879
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Sapporo, Japão
- Site Reference ID/Investigator# 46917
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Shimotsuke, Japão
- Site Reference ID/Investigator# 46942
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Shizuoka, Japão
- Site Reference ID/Investigator# 46854
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Shizuoka, Japão
- Site Reference ID/Investigator# 46857
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Shizuoka, Japão
- Site Reference ID/Investigator# 46859
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Takamatsu, Japão
- Site Reference ID/Investigator# 46895
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Tokyo, Japão
- Site Reference ID/Investigator# 46843
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Tokyo, Japão
- Site Reference ID/Investigator# 46844
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Tokyo, Japão
- Site Reference ID/Investigator# 46850
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Tokyo, Japão
- Site Reference ID/Investigator# 46882
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Tokyo, Japão
- Site Reference ID/Investigator# 46883
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Tokyo, Japão
- Site Reference ID/Investigator# 46884
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Tokyo, Japão
- Site Reference ID/Investigator# 46888
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Tokyo, Japão
- Site Reference ID/Investigator# 46889
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Tokyo, Japão
- Site Reference ID/Investigator# 46891
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Tokyo, Japão
- Site Reference ID/Investigator# 46896
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Toyama, Japão
- Site Reference ID/Investigator# 46849
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Toyama, Japão
- Site Reference ID/Investigator# 46907
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Toyoake, Japão
- Site Reference ID/Investigator# 46862
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Toyohashi, Japão
- Site Reference ID/Investigator# 46866
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Tsu, Japão
- Site Reference ID/Investigator# 46863
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Tsukuba, Japão
- Site Reference ID/Investigator# 46926
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Yokohama, Japão
- Site Reference ID/Investigator# 46897
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Yokohama, Japão
- Site Reference ID/Investigator# 46905
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: 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)
Outros nomes:
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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)
Outros nomes:
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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)
Outros nomes:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Outros nomes:
|
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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.
|
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Outros nomes:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Outros nomes:
|
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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.
|
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Outros nomes:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Outros nomes:
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
Outros nomes:
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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.
|
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Outros nomes:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Outros nomes:
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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Prazo: 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)
Prazo: 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)
Prazo: Week 26
|
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
Prazo: Baseline, Week 26
|
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
Prazo: Week 26
|
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
Prazo: Through Week 26
|
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.
|
Through Week 26
|
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Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
Prazo: Baseline, Week 52
|
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.
|
Baseline, Week 52
|
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Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Prazo: Week 52
|
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.
|
Week 52
|
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Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Prazo: Week 52
|
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.
|
Week 52
|
|
Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Prazo: Week 52
|
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.
|
Week 52
|
|
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
Prazo: 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.
|
Baseline, Week 52
|
|
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
Prazo: 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.
|
Week 52
|
|
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
Prazo: Through Week 52
|
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.
|
Through Week 52
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2009
Conclusão Primária (Real)
1 de março de 2011
Conclusão do estudo (Real)
1 de agosto de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
26 de março de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de março de 2009
Primeira postagem (Estimativa)
27 de março de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de agosto de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de agosto de 2012
Última verificação
1 de agosto de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- M06-859
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .