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A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

2013年6月18日 更新者：Bristol-Myers Squibb

A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures

The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

217

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 日本
      • Chiba-Shi、日本、260-0801
        • Local Institution
    • Aichi
      • Nagoya、Aichi、日本、466-8550
        • Local Institution
      • Nagoya-Shi、Aichi、日本、460-0001
        • Local Institution
    • Aomori
      • Goshogawara-Shi、Aomori、日本、037-0053
        • Local Institution
    • Chiba
      • Chiba-Shi、Chiba、日本
        • Local Institution
    • Fukui
      • Fukui-Shi、Fukui、日本、910-0041
        • Local Institution
      • Fukui-Shi、Fukui、日本、9100067
        • Local Institution
      • Fukui-Shi、Fukui、日本、9103133
        • Local Institution
    • Fukuoka
      • Fukuoka-Shi、Fukuoka、日本、810-0065
        • Local Institution
      • Fukuoka-Shi、Fukuoka、日本、812-0025
        • Local Institution
      • Kitakyushu-Shi、Fukuoka、日本、807-8555
        • Local Institution
    • Hiroshima
      • Higashi-Hiroshima-Shi、Hiroshima、日本、739-0002
        • Local Institution
    • Hokkaido
      • Sapporo City、Hokkaido、日本、060-8648
        • Local Institution
      • Sapporo-City、Hokkaido、日本、060-0001
        • Local Institution
      • Sapporo-City、Hokkaido、日本、060-8604
        • Local Institution
    • Hyogo
      • Kanzaki-Gun、Hyogo、日本、679-2414
        • Local Institution
      • Kato-Gun、Hyogo、日本、673-1462
        • Local Institution
    • Ibaraki
      • Hitachi-Shi、Ibaraki、日本、316-0035
        • Local Institution
      • Tsukuba-Shi、Ibaraki、日本、305-0005
        • Local Institution
    • Kanagawa
      • Sagamihara-Shi、Kanagawa、日本、228-8522
        • Local Institution
    • Miyagi
      • Sendai、Miyagi、日本
        • Local Institution
      • Sendai-Shi、Miyagi、日本、981-0911
        • Local Institution
      • Sendai-Shi、Miyagi、日本、982-0032
        • Local Institution
    • Nagano
      • Nagano-Shi、Nagano、日本、380-8582
        • Local Institution
    • Okayama
      • Tsukubo-Gun、Okayama、日本、701-0304
        • Local Institution
    • Osaka
      • Kawachinagano-Shi、Osaka、日本、86-0008
        • Local Institution
    • Saga
      • Ureshino-Shi、Saga、日本、843-0301
        • Local Institution
    • Saitama
      • Iruma-Gun、Saitama、日本、350-0495
        • Local Institution
      • Kawagoe-Shi、Saitama、日本、350-8550
        • Local Institution
      • Kitamoto-Shi、Saitama、日本、364-0026
        • Local Institution
    • Shizuoka
      • Hamamatsu-Shi、Shizuoka、日本、430-0906
        • Local Institution
    • Tochigi
      • Kawachigun、Tochigi、日本、329-1104
        • Local Institution
      • Shimotsuke-Shi、Tochigi、日本、3290498
        • Local Institution
    • Tokyo
      • Arakawa-Ku、Tokyo、日本、116-0011
        • Local Institution
      • Bunkyo-Ku、Tokyo、日本、113-0022
        • Local Institution
      • Bunkyo-Ku、Tokyo、日本、113-8519
        • Local Institution
      • Setagaya-Ku、Tokyo、日本、155-0032
        • Local Institution
      • Shinjuku-Ku、Tokyo、日本、162-0054
        • Local Institution
    • Toyama
      • Takaoka-Shi、Toyama、日本、933-8525
        • Local Institution

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria

  • The participants who completed the 169 days, full study period of Phase II (IM101-071) and were not administered other biologics between completion of IM101-071 and registration of this long-term study.
  • The participants of the Phase I study (IM101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept.
  • New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new subjects with MTX intolerance: RA patients who present an inadequate response to DMARDs).

Exclusion Criteria

  • Women of childbearing potential (WOCBP) who were unwilling or unable to use an acceptable method of contraception.
  • Participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in Japan) at registration.
  • Participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest).
  • Participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine, Cyclophosphamide, or immunoadsorption columns.
  • The participants who completed Phase II (IM101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (TB), with any opportunistic infections, laboratory values of hemoglobin < 8.5 g/dL, white blood cells (WBC) < 3,000/mm^3, Platelets < 100,000/mm^3, Serum creatinine > 2 times upper limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase > 2 times ULN.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Arm 1: Participants from Phase I study (IM101-034)
薬：Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
他の名前：
  • オレンシア®
  • BMS-188667
実験的：Arm 2: Participants from Phase II study (IM101-071)
薬：Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
他の名前：
  • オレンシア®
  • BMS-188667
実験的：Arm 3: New Participants with Methotrexate (MTX) Intolerance
薬：Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
他の名前：
  • オレンシア®
  • BMS-188667

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
時間枠：From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.
From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
Number of Participants With Abnormal Laboratory Changes (ALC)
時間枠：From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.
From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
時間枠：At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
時間枠：At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Percentage of Participants With ACR 50 Response Over Time
時間枠：At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Percentage of Participants With ACR 70 Response Over Time
時間枠：At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
時間枠：At BL (week 0), week 24, 48, 96, 144, and 192.
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data.
At BL (week 0), week 24, 48, 96, 144, and 192.
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.

The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.

Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
時間枠：At weeks 24, 48, 96, 144, and 192.
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.
At weeks 24, 48, 96, 144, and 192.
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
時間枠：At weeks 24, 48, 96, 144, and 192.

The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.

Participants with DAS 28 score < 2.6 were considered to be in remission.
At weeks 24, 48, 96, 144, and 192.
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
時間枠：At baseline (week 0), weeks 24, 48, 96, 144, and 192.
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.
At baseline (week 0), weeks 24, 48, 96, 144, and 192.
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
時間枠：At BL (Week 0), weeks 24, 48, 96, 144, and 192.
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.
At BL (Week 0), weeks 24, 48, 96, 144, and 192.
Baseline and Postbaseline C-reactive Protein (CRP) Levels
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Baseline and Postbaseline Rheumatoid Factor Levels
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
時間枠：At BL (week 0), weeks 24, 48, 96, 144, and 192.
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values.
At BL (week 0), weeks 24, 48, 96, 144, and 192.
Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies
時間枠：At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.
Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.
At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.
Abatacept PK Parameter: Total Body Clearance
時間枠：Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.
Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State
時間枠：Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.
Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Abatacept PK Parameter: Maximum Serum Concentration at Steady State
時間枠：Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).
Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Abatacept PK Parameter: Minimum Plasma Concentration at Steady State
時間枠：Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.
Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Bristol-Myers Squibb

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2006年12月1日

一次修了 (実際)

2010年12月1日

研究の完了 (実際)

2010年12月1日

試験登録日

最初に提出

2007年6月7日

QC基準を満たした最初の提出物

2007年6月7日

最初の投稿 (見積もり)

2007年6月8日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年6月24日

QC基準を満たした最後の更新が送信されました

2013年6月18日

最終確認日

2013年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • IM101-129

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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