A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
1 augustus 2012 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
334
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Anjo, Japan
- Site Reference ID/Investigator# 46861
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Aomori, Japan
- Site Reference ID/Investigator# 46919
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Chiba, Japan
- Site Reference ID/Investigator# 46805
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Chiba, Japan
- Site Reference ID/Investigator# 46806
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Chiba, Japan
- Site Reference ID/Investigator# 46880
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Chiba, Japan
- Site Reference ID/Investigator# 46881
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Fuchu, Japan
- Site Reference ID/Investigator# 46890
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Fukuoka, Japan
- Site Reference ID/Investigator# 46902
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Fukuoka, Japan
- Site Reference ID/Investigator# 46903
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Fukuoka, Japan
- Site Reference ID/Investigator# 46904
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Gifu, Japan
- Site Reference ID/Investigator# 46856
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Gunma, Japan
- Site Reference ID/Investigator# 46944
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Hiroshima, Japan
- Site Reference ID/Investigator# 46893
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Hiroshima, Japan
- Site Reference ID/Investigator# 46894
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Hokkaido, Japan
- Site Reference ID/Investigator# 12161
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Hokkaido, Japan
- Site Reference ID/Investigator# 46916
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Hokkaido, Japan
- Site Reference ID/Investigator# 46918
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Hyogo, Japan
- Site Reference ID/Investigator# 46865
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Hyogo, Japan
- Site Reference ID/Investigator# 46871
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Ibaraki, Japan
- Site Reference ID/Investigator# 46801
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Ibaraki, Japan
- Site Reference ID/Investigator# 46925
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Iwate, Japan
- Site Reference ID/Investigator# 46800
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Kagoshima, Japan
- Site Reference ID/Investigator# 46873
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Kagoshima, Japan
- Site Reference ID/Investigator# 46874
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Kanagawa, Japan
- Site Reference ID/Investigator# 46845
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Kanagawa, Japan
- Site Reference ID/Investigator# 46899
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Kanagawa, Japan
- Site Reference ID/Investigator# 46901
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Kanazawa, Japan
- Site Reference ID/Investigator# 46851
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Kanazawa, Japan
- Site Reference ID/Investigator# 46852
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Kawagoe, Japan
- Site Reference ID/Investigator# 46802
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Kawasaki, Japan
- Site Reference ID/Investigator# 46900
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Kirishima, Japan
- Site Reference ID/Investigator# 46875
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Kitakyushu, Japan
- Site Reference ID/Investigator# 46870
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Kumamoto, Japan
- Site Reference ID/Investigator# 46872
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Kumamoto, Japan
- Site Reference ID/Investigator# 46912
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Kyoto, Japan
- Site Reference ID/Investigator# 46864
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Maebashi, Japan
- Site Reference ID/Investigator# 46943
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Matsuyama, Japan
- Site Reference ID/Investigator# 46898
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Miyazaki, Japan
- Site Reference ID/Investigator# 46915
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Nagano, Japan
- Site Reference ID/Investigator# 46853
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Nagano, Japan
- Site Reference ID/Investigator# 46855
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Nagasaki, Japan
- Site Reference ID/Investigator# 46909
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Nagasaki, Japan
- Site Reference ID/Investigator# 46910
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Nagasaki, Japan
- Site Reference ID/Investigator# 46911
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Nagoya, Japan
- Site Reference ID/Investigator# 46858
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Nagoya, Japan
- Site Reference ID/Investigator# 46860
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Nara, Japan
- Site Reference ID/Investigator# 46877
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Nara, Japan
- Site Reference ID/Investigator# 46885
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Niigata, Japan
- Site Reference ID/Investigator# 46848
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Niigata, Japan
- Site Reference ID/Investigator# 46906
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Oita, Japan
- Site Reference ID/Investigator# 46914
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Okayama, Japan
- Site Reference ID/Investigator# 46869
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Okayama, Japan
- Site Reference ID/Investigator# 46886
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Okayama, Japan
- Site Reference ID/Investigator# 46887
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Okayama, Japan
- Site Reference ID/Investigator# 46892
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Okinawa, Japan
- Site Reference ID/Investigator# 46876
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Osaka, Japan
- Site Reference ID/Investigator# 46946
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Osaka, Japan
- Site Reference ID/Investigator# 46947
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Rifu, Japan
- Site Reference ID/Investigator# 46842
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Sagamihara, Japan
- Site Reference ID/Investigator# 46846
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Saitama, Japan
- Site Reference ID/Investigator# 46803
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Saitama, Japan
- Site Reference ID/Investigator# 46804
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Saitama, Japan
- Site Reference ID/Investigator# 46878
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Saitama, Japan
- Site Reference ID/Investigator# 46879
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Sapporo, Japan
- Site Reference ID/Investigator# 46917
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Shimotsuke, Japan
- Site Reference ID/Investigator# 46942
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Shizuoka, Japan
- Site Reference ID/Investigator# 46854
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Shizuoka, Japan
- Site Reference ID/Investigator# 46857
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Shizuoka, Japan
- Site Reference ID/Investigator# 46859
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Takamatsu, Japan
- Site Reference ID/Investigator# 46895
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Tokyo, Japan
- Site Reference ID/Investigator# 46843
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Tokyo, Japan
- Site Reference ID/Investigator# 46844
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Tokyo, Japan
- Site Reference ID/Investigator# 46850
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Tokyo, Japan
- Site Reference ID/Investigator# 46882
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Tokyo, Japan
- Site Reference ID/Investigator# 46883
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Tokyo, Japan
- Site Reference ID/Investigator# 46884
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Tokyo, Japan
- Site Reference ID/Investigator# 46888
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Tokyo, Japan
- Site Reference ID/Investigator# 46889
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Tokyo, Japan
- Site Reference ID/Investigator# 46891
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Tokyo, Japan
- Site Reference ID/Investigator# 46896
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Toyama, Japan
- Site Reference ID/Investigator# 46849
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Toyama, Japan
- Site Reference ID/Investigator# 46907
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Toyoake, Japan
- Site Reference ID/Investigator# 46862
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Toyohashi, Japan
- Site Reference ID/Investigator# 46866
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Tsu, Japan
- Site Reference ID/Investigator# 46863
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Tsukuba, Japan
- Site Reference ID/Investigator# 46926
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Yokohama, Japan
- Site Reference ID/Investigator# 46897
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Yokohama, Japan
- Site Reference ID/Investigator# 46905
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: 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)
Andere namen:
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Experimenteel: 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)
Andere namen:
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Experimenteel: 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)
Andere namen:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere namen:
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Experimenteel: 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)
Andere namen:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere namen:
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Experimenteel: 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)
Andere namen:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere namen:
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
Andere namen:
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Experimenteel: 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)
Andere namen:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere namen:
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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Baseline, Week 52
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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 52
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Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
Tijdsspanne: Week 52
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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 52
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Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2009
Primaire voltooiing (Werkelijk)
1 maart 2011
Studie voltooiing (Werkelijk)
1 augustus 2011
Studieregistratiedata
Eerst ingediend
26 maart 2009
Eerst ingediend dat voldeed aan de QC-criteria
26 maart 2009
Eerst geplaatst (Schatting)
27 maart 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
7 augustus 2012
Laatste update ingediend die voldeed aan QC-criteria
1 augustus 2012
Laatst geverifieerd
1 augustus 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M06-859
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .