A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
1. srpna 2012 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
334
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Anjo, Japonsko
- Site Reference ID/Investigator# 46861
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Aomori, Japonsko
- Site Reference ID/Investigator# 46919
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Chiba, Japonsko
- Site Reference ID/Investigator# 46805
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Chiba, Japonsko
- Site Reference ID/Investigator# 46806
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Chiba, Japonsko
- Site Reference ID/Investigator# 46880
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Chiba, Japonsko
- Site Reference ID/Investigator# 46881
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Fuchu, Japonsko
- Site Reference ID/Investigator# 46890
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Fukuoka, Japonsko
- Site Reference ID/Investigator# 46902
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Fukuoka, Japonsko
- Site Reference ID/Investigator# 46903
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Fukuoka, Japonsko
- Site Reference ID/Investigator# 46904
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Gifu, Japonsko
- Site Reference ID/Investigator# 46856
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Gunma, Japonsko
- Site Reference ID/Investigator# 46944
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Hiroshima, Japonsko
- Site Reference ID/Investigator# 46893
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Hiroshima, Japonsko
- Site Reference ID/Investigator# 46894
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Hokkaido, Japonsko
- Site Reference ID/Investigator# 12161
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Hokkaido, Japonsko
- Site Reference ID/Investigator# 46916
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Hokkaido, Japonsko
- Site Reference ID/Investigator# 46918
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Hyogo, Japonsko
- Site Reference ID/Investigator# 46865
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Hyogo, Japonsko
- Site Reference ID/Investigator# 46871
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Ibaraki, Japonsko
- Site Reference ID/Investigator# 46801
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Ibaraki, Japonsko
- Site Reference ID/Investigator# 46925
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Iwate, Japonsko
- Site Reference ID/Investigator# 46800
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Kagoshima, Japonsko
- Site Reference ID/Investigator# 46873
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Kagoshima, Japonsko
- Site Reference ID/Investigator# 46874
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Kanagawa, Japonsko
- Site Reference ID/Investigator# 46845
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Kanagawa, Japonsko
- Site Reference ID/Investigator# 46899
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Kanagawa, Japonsko
- Site Reference ID/Investigator# 46901
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Kanazawa, Japonsko
- Site Reference ID/Investigator# 46851
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Kanazawa, Japonsko
- Site Reference ID/Investigator# 46852
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Kawagoe, Japonsko
- Site Reference ID/Investigator# 46802
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Kawasaki, Japonsko
- Site Reference ID/Investigator# 46900
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Kirishima, Japonsko
- Site Reference ID/Investigator# 46875
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Kitakyushu, Japonsko
- Site Reference ID/Investigator# 46870
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Kumamoto, Japonsko
- Site Reference ID/Investigator# 46872
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Kumamoto, Japonsko
- Site Reference ID/Investigator# 46912
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Kyoto, Japonsko
- Site Reference ID/Investigator# 46864
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Maebashi, Japonsko
- Site Reference ID/Investigator# 46943
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Matsuyama, Japonsko
- Site Reference ID/Investigator# 46898
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Miyazaki, Japonsko
- Site Reference ID/Investigator# 46915
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Nagano, Japonsko
- Site Reference ID/Investigator# 46853
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Nagano, Japonsko
- Site Reference ID/Investigator# 46855
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Nagasaki, Japonsko
- Site Reference ID/Investigator# 46909
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Nagasaki, Japonsko
- Site Reference ID/Investigator# 46910
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Nagasaki, Japonsko
- Site Reference ID/Investigator# 46911
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Nagoya, Japonsko
- Site Reference ID/Investigator# 46858
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Nagoya, Japonsko
- Site Reference ID/Investigator# 46860
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Nara, Japonsko
- Site Reference ID/Investigator# 46877
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Nara, Japonsko
- Site Reference ID/Investigator# 46885
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Niigata, Japonsko
- Site Reference ID/Investigator# 46848
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Niigata, Japonsko
- Site Reference ID/Investigator# 46906
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Oita, Japonsko
- Site Reference ID/Investigator# 46914
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Okayama, Japonsko
- Site Reference ID/Investigator# 46869
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Okayama, Japonsko
- Site Reference ID/Investigator# 46886
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Okayama, Japonsko
- Site Reference ID/Investigator# 46887
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Okayama, Japonsko
- Site Reference ID/Investigator# 46892
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Okinawa, Japonsko
- Site Reference ID/Investigator# 46876
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Osaka, Japonsko
- Site Reference ID/Investigator# 46946
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Osaka, Japonsko
- Site Reference ID/Investigator# 46947
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Rifu, Japonsko
- Site Reference ID/Investigator# 46842
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Sagamihara, Japonsko
- Site Reference ID/Investigator# 46846
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Saitama, Japonsko
- Site Reference ID/Investigator# 46803
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Saitama, Japonsko
- Site Reference ID/Investigator# 46804
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Saitama, Japonsko
- Site Reference ID/Investigator# 46878
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Saitama, Japonsko
- Site Reference ID/Investigator# 46879
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Sapporo, Japonsko
- Site Reference ID/Investigator# 46917
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Shimotsuke, Japonsko
- Site Reference ID/Investigator# 46942
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Shizuoka, Japonsko
- Site Reference ID/Investigator# 46854
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Shizuoka, Japonsko
- Site Reference ID/Investigator# 46857
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Shizuoka, Japonsko
- Site Reference ID/Investigator# 46859
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Takamatsu, Japonsko
- Site Reference ID/Investigator# 46895
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46843
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46844
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46850
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46882
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46883
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46884
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46888
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46889
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46891
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Tokyo, Japonsko
- Site Reference ID/Investigator# 46896
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Toyama, Japonsko
- Site Reference ID/Investigator# 46849
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Toyama, Japonsko
- Site Reference ID/Investigator# 46907
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Toyoake, Japonsko
- Site Reference ID/Investigator# 46862
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Toyohashi, Japonsko
- Site Reference ID/Investigator# 46866
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Tsu, Japonsko
- Site Reference ID/Investigator# 46863
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Tsukuba, Japonsko
- Site Reference ID/Investigator# 46926
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Yokohama, Japonsko
- Site Reference ID/Investigator# 46897
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Yokohama, Japonsko
- Site Reference ID/Investigator# 46905
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: 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)
Ostatní jména:
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Experimentální: 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)
Ostatní jména:
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Experimentální: 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.
|
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Ostatní jména:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Ostatní jména:
|
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Experimentální: 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)
Ostatní jména:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Ostatní jména:
|
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Experimentální: 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)
Ostatní jména:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Ostatní jména:
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
Ostatní jména:
|
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Experimentální: 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)
Ostatní jména:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Ostatní jména:
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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Časové okno: Baseline, Week 26
|
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.
|
Baseline, Week 26
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Časové okno: Week 26
|
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)
Časové okno: Week 26
|
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.
|
Week 26
|
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Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Časové okno: 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.
|
Week 26
|
|
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
Časové okno: 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.
|
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
Časové okno: 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.
|
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
Časové okno: 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
|
|
Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
Časové okno: 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
|
|
Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Časové okno: 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
|
|
Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2009
Primární dokončení (Aktuální)
1. března 2011
Dokončení studie (Aktuální)
1. srpna 2011
Termíny zápisu do studia
První předloženo
26. března 2009
První předloženo, které splnilo kritéria kontroly kvality
26. března 2009
První zveřejněno (Odhad)
27. března 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
7. srpna 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. srpna 2012
Naposledy ověřeno
1. srpna 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- M06-859
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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