A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
1 agosto 2012 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
334
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Anjo, Giappone
- Site Reference ID/Investigator# 46861
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Aomori, Giappone
- Site Reference ID/Investigator# 46919
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Chiba, Giappone
- Site Reference ID/Investigator# 46805
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Chiba, Giappone
- Site Reference ID/Investigator# 46806
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Chiba, Giappone
- Site Reference ID/Investigator# 46880
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Chiba, Giappone
- Site Reference ID/Investigator# 46881
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Fuchu, Giappone
- Site Reference ID/Investigator# 46890
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Fukuoka, Giappone
- Site Reference ID/Investigator# 46902
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Fukuoka, Giappone
- Site Reference ID/Investigator# 46903
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Fukuoka, Giappone
- Site Reference ID/Investigator# 46904
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Gifu, Giappone
- Site Reference ID/Investigator# 46856
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Gunma, Giappone
- Site Reference ID/Investigator# 46944
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Hiroshima, Giappone
- Site Reference ID/Investigator# 46893
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Hiroshima, Giappone
- Site Reference ID/Investigator# 46894
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Hokkaido, Giappone
- Site Reference ID/Investigator# 12161
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Hokkaido, Giappone
- Site Reference ID/Investigator# 46916
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Hokkaido, Giappone
- Site Reference ID/Investigator# 46918
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Hyogo, Giappone
- Site Reference ID/Investigator# 46865
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Hyogo, Giappone
- Site Reference ID/Investigator# 46871
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Ibaraki, Giappone
- Site Reference ID/Investigator# 46801
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Ibaraki, Giappone
- Site Reference ID/Investigator# 46925
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Iwate, Giappone
- Site Reference ID/Investigator# 46800
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Kagoshima, Giappone
- Site Reference ID/Investigator# 46873
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Kagoshima, Giappone
- Site Reference ID/Investigator# 46874
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Kanagawa, Giappone
- Site Reference ID/Investigator# 46845
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Kanagawa, Giappone
- Site Reference ID/Investigator# 46899
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Kanagawa, Giappone
- Site Reference ID/Investigator# 46901
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Kanazawa, Giappone
- Site Reference ID/Investigator# 46851
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Kanazawa, Giappone
- Site Reference ID/Investigator# 46852
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Kawagoe, Giappone
- Site Reference ID/Investigator# 46802
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Kawasaki, Giappone
- Site Reference ID/Investigator# 46900
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Kirishima, Giappone
- Site Reference ID/Investigator# 46875
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Kitakyushu, Giappone
- Site Reference ID/Investigator# 46870
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Kumamoto, Giappone
- Site Reference ID/Investigator# 46872
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Kumamoto, Giappone
- Site Reference ID/Investigator# 46912
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Kyoto, Giappone
- Site Reference ID/Investigator# 46864
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Maebashi, Giappone
- Site Reference ID/Investigator# 46943
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Matsuyama, Giappone
- Site Reference ID/Investigator# 46898
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Miyazaki, Giappone
- Site Reference ID/Investigator# 46915
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Nagano, Giappone
- Site Reference ID/Investigator# 46853
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Nagano, Giappone
- Site Reference ID/Investigator# 46855
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Nagasaki, Giappone
- Site Reference ID/Investigator# 46909
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Nagasaki, Giappone
- Site Reference ID/Investigator# 46910
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Nagasaki, Giappone
- Site Reference ID/Investigator# 46911
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Nagoya, Giappone
- Site Reference ID/Investigator# 46858
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Nagoya, Giappone
- Site Reference ID/Investigator# 46860
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Nara, Giappone
- Site Reference ID/Investigator# 46877
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Nara, Giappone
- Site Reference ID/Investigator# 46885
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Niigata, Giappone
- Site Reference ID/Investigator# 46848
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Niigata, Giappone
- Site Reference ID/Investigator# 46906
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Oita, Giappone
- Site Reference ID/Investigator# 46914
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Okayama, Giappone
- Site Reference ID/Investigator# 46869
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Okayama, Giappone
- Site Reference ID/Investigator# 46886
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Okayama, Giappone
- Site Reference ID/Investigator# 46887
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Okayama, Giappone
- Site Reference ID/Investigator# 46892
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Okinawa, Giappone
- Site Reference ID/Investigator# 46876
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Osaka, Giappone
- Site Reference ID/Investigator# 46946
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Osaka, Giappone
- Site Reference ID/Investigator# 46947
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Rifu, Giappone
- Site Reference ID/Investigator# 46842
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Sagamihara, Giappone
- Site Reference ID/Investigator# 46846
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Saitama, Giappone
- Site Reference ID/Investigator# 46803
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Saitama, Giappone
- Site Reference ID/Investigator# 46804
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Saitama, Giappone
- Site Reference ID/Investigator# 46878
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Saitama, Giappone
- Site Reference ID/Investigator# 46879
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Sapporo, Giappone
- Site Reference ID/Investigator# 46917
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Shimotsuke, Giappone
- Site Reference ID/Investigator# 46942
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Shizuoka, Giappone
- Site Reference ID/Investigator# 46854
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Shizuoka, Giappone
- Site Reference ID/Investigator# 46857
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Shizuoka, Giappone
- Site Reference ID/Investigator# 46859
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Takamatsu, Giappone
- Site Reference ID/Investigator# 46895
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Tokyo, Giappone
- Site Reference ID/Investigator# 46843
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Tokyo, Giappone
- Site Reference ID/Investigator# 46844
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Tokyo, Giappone
- Site Reference ID/Investigator# 46850
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Tokyo, Giappone
- Site Reference ID/Investigator# 46882
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Tokyo, Giappone
- Site Reference ID/Investigator# 46883
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Tokyo, Giappone
- Site Reference ID/Investigator# 46884
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Tokyo, Giappone
- Site Reference ID/Investigator# 46888
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Tokyo, Giappone
- Site Reference ID/Investigator# 46889
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Tokyo, Giappone
- Site Reference ID/Investigator# 46891
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Tokyo, Giappone
- Site Reference ID/Investigator# 46896
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Toyama, Giappone
- Site Reference ID/Investigator# 46849
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Toyama, Giappone
- Site Reference ID/Investigator# 46907
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Toyoake, Giappone
- Site Reference ID/Investigator# 46862
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Toyohashi, Giappone
- Site Reference ID/Investigator# 46866
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Tsu, Giappone
- Site Reference ID/Investigator# 46863
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Tsukuba, Giappone
- Site Reference ID/Investigator# 46926
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Yokohama, Giappone
- Site Reference ID/Investigator# 46897
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Yokohama, Giappone
- Site Reference ID/Investigator# 46905
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
20 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore 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)
Altri nomi:
|
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Sperimentale: 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)
Altri nomi:
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Sperimentale: 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)
Altri nomi:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Altri nomi:
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Sperimentale: 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)
Altri nomi:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Altri nomi:
|
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Sperimentale: 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)
Altri nomi:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Altri nomi:
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
Altri nomi:
|
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Sperimentale: 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)
Altri nomi:
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Altri nomi:
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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Lasso di tempo: 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.
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Baseline, Week 26
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Lasso di tempo: 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.
|
Week 26
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Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
Lasso di tempo: 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
|
|
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2009
Completamento primario (Effettivo)
1 marzo 2011
Completamento dello studio (Effettivo)
1 agosto 2011
Date di iscrizione allo studio
Primo inviato
26 marzo 2009
Primo inviato che soddisfa i criteri di controllo qualità
26 marzo 2009
Primo Inserito (Stima)
27 marzo 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
7 agosto 2012
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 agosto 2012
Ultimo verificato
1 agosto 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- M06-859
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .