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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

1. August 2012 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

334

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Japan
      • Anjo, Japan
        • Site Reference ID/Investigator# 46861
      • Aomori, Japan
        • Site Reference ID/Investigator# 46919
      • Chiba, Japan
        • Site Reference ID/Investigator# 46805
      • Chiba, Japan
        • Site Reference ID/Investigator# 46806
      • Chiba, Japan
        • Site Reference ID/Investigator# 46880
      • Chiba, Japan
        • Site Reference ID/Investigator# 46881
      • Fuchu, Japan
        • Site Reference ID/Investigator# 46890
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 46902
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 46903
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 46904
      • Gifu, Japan
        • Site Reference ID/Investigator# 46856
      • Gunma, Japan
        • Site Reference ID/Investigator# 46944
      • Hiroshima, Japan
        • Site Reference ID/Investigator# 46893
      • Hiroshima, Japan
        • Site Reference ID/Investigator# 46894
      • Hokkaido, Japan
        • Site Reference ID/Investigator# 12161
      • Hokkaido, Japan
        • Site Reference ID/Investigator# 46916
      • Hokkaido, Japan
        • Site Reference ID/Investigator# 46918
      • Hyogo, Japan
        • Site Reference ID/Investigator# 46865
      • Hyogo, Japan
        • Site Reference ID/Investigator# 46871
      • Ibaraki, Japan
        • Site Reference ID/Investigator# 46801
      • Ibaraki, Japan
        • Site Reference ID/Investigator# 46925
      • Iwate, Japan
        • Site Reference ID/Investigator# 46800
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 46873
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 46874
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 46845
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 46899
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 46901
      • Kanazawa, Japan
        • Site Reference ID/Investigator# 46851
      • Kanazawa, Japan
        • Site Reference ID/Investigator# 46852
      • Kawagoe, Japan
        • Site Reference ID/Investigator# 46802
      • Kawasaki, Japan
        • Site Reference ID/Investigator# 46900
      • Kirishima, Japan
        • Site Reference ID/Investigator# 46875
      • Kitakyushu, Japan
        • Site Reference ID/Investigator# 46870
      • Kumamoto, Japan
        • Site Reference ID/Investigator# 46872
      • Kumamoto, Japan
        • Site Reference ID/Investigator# 46912
      • Kyoto, Japan
        • Site Reference ID/Investigator# 46864
      • Maebashi, Japan
        • Site Reference ID/Investigator# 46943
      • Matsuyama, Japan
        • Site Reference ID/Investigator# 46898
      • Miyazaki, Japan
        • Site Reference ID/Investigator# 46915
      • Nagano, Japan
        • Site Reference ID/Investigator# 46853
      • Nagano, Japan
        • Site Reference ID/Investigator# 46855
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 46909
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 46910
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 46911
      • Nagoya, Japan
        • Site Reference ID/Investigator# 46858
      • Nagoya, Japan
        • Site Reference ID/Investigator# 46860
      • Nara, Japan
        • Site Reference ID/Investigator# 46877
      • Nara, Japan
        • Site Reference ID/Investigator# 46885
      • Niigata, Japan
        • Site Reference ID/Investigator# 46848
      • Niigata, Japan
        • Site Reference ID/Investigator# 46906
      • Oita, Japan
        • Site Reference ID/Investigator# 46914
      • Okayama, Japan
        • Site Reference ID/Investigator# 46869
      • Okayama, Japan
        • Site Reference ID/Investigator# 46886
      • Okayama, Japan
        • Site Reference ID/Investigator# 46887
      • Okayama, Japan
        • Site Reference ID/Investigator# 46892
      • Okinawa, Japan
        • Site Reference ID/Investigator# 46876
      • Osaka, Japan
        • Site Reference ID/Investigator# 46946
      • Osaka, Japan
        • Site Reference ID/Investigator# 46947
      • Rifu, Japan
        • Site Reference ID/Investigator# 46842
      • Sagamihara, Japan
        • Site Reference ID/Investigator# 46846
      • Saitama, Japan
        • Site Reference ID/Investigator# 46803
      • Saitama, Japan
        • Site Reference ID/Investigator# 46804
      • Saitama, Japan
        • Site Reference ID/Investigator# 46878
      • Saitama, Japan
        • Site Reference ID/Investigator# 46879
      • Sapporo, Japan
        • Site Reference ID/Investigator# 46917
      • Shimotsuke, Japan
        • Site Reference ID/Investigator# 46942
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 46854
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 46857
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 46859
      • Takamatsu, Japan
        • Site Reference ID/Investigator# 46895
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46843
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46844
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46850
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46882
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46883
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46884
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46888
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46889
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46891
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46896
      • Toyama, Japan
        • Site Reference ID/Investigator# 46849
      • Toyama, Japan
        • Site Reference ID/Investigator# 46907
      • Toyoake, Japan
        • Site Reference ID/Investigator# 46862
      • Toyohashi, Japan
        • Site Reference ID/Investigator# 46866
      • Tsu, Japan
        • Site Reference ID/Investigator# 46863
      • Tsukuba, Japan
        • Site Reference ID/Investigator# 46926
      • Yokohama, Japan
        • Site Reference ID/Investigator# 46897
      • Yokohama, Japan
        • Site Reference ID/Investigator# 46905

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: 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.
Arzneimittel: Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Andere Namen:
  • Placebo
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.
Biologisch: Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Andere Namen:
  • ABT-D2E7, Adalimumab, Humira
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.
Biologisch: Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Andere Namen:
  • ABT-D2E7, Adalimumab, Humira
Biologisch: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere Namen:
  • Adalimumab
  • ABT-D2E7
  • Humira
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.
Arzneimittel: Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Andere Namen:
  • Placebo
Biologisch: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere Namen:
  • Adalimumab
  • ABT-D2E7
  • Humira
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.
Biologisch: Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Andere Namen:
  • ABT-D2E7, Adalimumab, Humira
Biologisch: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere Namen:
  • Adalimumab
  • ABT-D2E7
  • Humira
Biologisch: Open-labelAdalimumabRescue
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:
  • Adalimumab
  • ABT-D2E7
  • Humira
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.
Arzneimittel: Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Andere Namen:
  • Placebo
Biologisch: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andere Namen:
  • Adalimumab
  • ABT-D2E7
  • Humira
Biologisch: Open-labelAdalimumabRescue
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:
  • Adalimumab
  • ABT-D2E7
  • Humira

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Zeitfenster: 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
Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Zeitfenster: 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
Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Abbott

Mitarbeiter

Eisai Co., Ltd.

Ermittler

  • Studienleiter: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2009

Primärer Abschluss (Tatsächlich)

1. März 2011

Studienabschluss (Tatsächlich)

1. August 2011

Studienanmeldedaten

Zuerst eingereicht

26. März 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. März 2009

Zuerst gepostet (Schätzen)

27. März 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

7. August 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. August 2012

Zuletzt verifiziert

1. August 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • M06-859

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