このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia

2018年10月9日 更新者：Novartis Pharmaceuticals

An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)

The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Patients with CLL that is refractory to fludarabine have few treatment options and a poor prognosis. There is a continued need for new therapies for these CLL patients, as demonstrated by the limited responses and substantial toxicities with existing therapies. This is supported by the lack of a consensus around standard of care treatment for CLL patients with bulky fludarabine-refractory disease. The objective of this study was to confirm the response rate and disease control in the refractory setting through a controlled trial comparing ofatumumab with the physicians' choice of therapy in fludarabine-refractory, bulky lymphadenopathy patients. After 24 weeks of treatment with ofatumumab, patients were further randomized to either extended ofatumumab treatment or observation. Patients on the physicians' choice arm had the option of receiving ofatumumab if they experience progressive disease.

研究の種類

介入

入学 (実際)

122

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

  • アイルランド
      • Dublin、アイルランド、7
        • Novartis Investigative Site
      • Galway、アイルランド
        • Novartis Investigative Site
      • James Street、アイルランド、8
        • Novartis Investigative Site
  • イギリス
      • Bournemouth、イギリス、BH7 7DW
        • Novartis Investigative Site
      • Manchester、イギリス、M20 4BX
        • Novartis Investigative Site
      • Oxford、イギリス、OX3 7LE
        • Novartis Investigative Site
  • イスラエル
      • Jerusalem、イスラエル、91120
        • Novartis Investigative Site
      • Ramat Gan、イスラエル、52621
        • Novartis Investigative Site
  • イタリア
    • Emilia-Romagna
      • Modena、Emilia-Romagna、イタリア、41124
        • Novartis Investigative Site
    • Lombardia
      • Brescia、Lombardia、イタリア、25123
        • Novartis Investigative Site
      • Milano、Lombardia、イタリア、20162
        • Novartis Investigative Site
      • Milano、Lombardia、イタリア、20132
        • Novartis Investigative Site
    • Piemonte
      • Torino、Piemonte、イタリア、10126
        • Novartis Investigative Site
    • Sicilia
      • Messina、Sicilia、イタリア、95158
        • Novartis Investigative Site
  • ウクライナ
      • Cherkasy、ウクライナ、18009
        • Novartis Investigative Site
      • Dnipropetrovsk、ウクライナ、49102
        • Novartis Investigative Site
      • Donetsk、ウクライナ、83045
        • Novartis Investigative Site
      • Kharkiv、ウクライナ、61070
        • Novartis Investigative Site
      • Khmelnytskyi、ウクライナ、29000
        • Novartis Investigative Site
      • Kyiv、ウクライナ、03022
        • Novartis Investigative Site
      • Kyiv、ウクライナ、04112
        • Novartis Investigative Site
      • Lviv、ウクライナ、79044
        • Novartis Investigative Site
      • Makiivka、ウクライナ、86132
        • Novartis Investigative Site
      • Simferopil、ウクライナ、95023
        • Novartis Investigative Site
      • Vinnitsa、ウクライナ、21018
        • Novartis Investigative Site
      • Zhytomyr、ウクライナ、10002
        • Novartis Investigative Site
  • オーストリア
      • Graz、オーストリア、8036
        • Novartis Investigative Site
      • Innsbruck、オーストリア、6020
        • Novartis Investigative Site
      • Linz、オーストリア、4020
        • Novartis Investigative Site
      • Salzburg、オーストリア、A-5020
        • Novartis Investigative Site
      • Wien、オーストリア、1140
        • Novartis Investigative Site
  • シンガポール
      • Singapore、シンガポール、169608
        • Novartis Investigative Site
  • スウェーデン
      • Goteborg、スウェーデン、SE-413 45
        • Novartis Investigative Site
      • Linkoping、スウェーデン、SE-581 85
        • Novartis Investigative Site
      • Lulea、スウェーデン、SE-971 80
        • Novartis Investigative Site
      • Orebro、スウェーデン、SE-701 85
        • Novartis Investigative Site
      • Stockholm、スウェーデン、SE-171 76
        • Novartis Investigative Site
      • Umea、スウェーデン、SE-901 85
        • Novartis Investigative Site
      • Uppsala、スウェーデン、SE-751 85
        • Novartis Investigative Site
  • スロバキア
      • Bratislava、スロバキア、833 10
        • Novartis Investigative Site
      • Bratislava、スロバキア、851 07
        • Novartis Investigative Site
      • Kosice、スロバキア、041 66
        • Novartis Investigative Site
      • Martin、スロバキア、036 59
        • Novartis Investigative Site
  • チェコ
      • Hradec Kralove、チェコ
        • Novartis Investigative Site
      • Olomouc、チェコ、775 20
        • Novartis Investigative Site
      • Praha 2、チェコ、128 08
        • Novartis Investigative Site
  • ドイツ
    • Bayern
      • Kronach、Bayern、ドイツ、96317
        • Novartis Investigative Site
      • Regensburg、Bayern、ドイツ、93053
        • Novartis Investigative Site
    • Brandenburg
      • Frankfurt/Oder、Brandenburg、ドイツ、15236
        • Novartis Investigative Site
    • Hessen
      • Frankfurt、Hessen、ドイツ、60590
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Essen、Nordrhein-Westfalen、ドイツ、45122
        • Novartis Investigative Site
      • Koeln、Nordrhein-Westfalen、ドイツ、50937
        • Novartis Investigative Site
    • Rheinland-Pfalz
      • Koblenz、Rheinland-Pfalz、ドイツ、56068
        • Novartis Investigative Site
    • Sachsen
      • Chemnitz、Sachsen、ドイツ、09113
        • Novartis Investigative Site
      • Dresden、Sachsen、ドイツ、01307
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Magdeburg、Sachsen-Anhalt、ドイツ、39130
        • Novartis Investigative Site
  • ハンガリー
      • Budapest、ハンガリー、1097
        • Novartis Investigative Site
      • Debrecen、ハンガリー、4012
        • Novartis Investigative Site
      • Pecs、ハンガリー、7624
        • Novartis Investigative Site
      • Szombathely、ハンガリー、9700
        • Novartis Investigative Site
  • フランス
      • Bobigny cedex、フランス、93009
        • Novartis Investigative Site
      • Brest cedex、フランス、29609
        • Novartis Investigative Site
      • Clermont-Ferrand Cedex 1、フランス、63003
        • Novartis Investigative Site
      • Creteil cedex、フランス、94010
        • Novartis Investigative Site
      • Lille cedex、フランス、59037
        • Novartis Investigative Site
      • Rennes cedex 9、フランス、35033
        • Novartis Investigative Site
      • Toulouse cedex 9、フランス、31059
        • Novartis Investigative Site
      • Tours cedex 9、フランス、37044
        • Novartis Investigative Site
  • ブルガリア
      • Sofia、ブルガリア、1431
        • Novartis Investigative Site
      • Sofia、ブルガリア、1407
        • Novartis Investigative Site
      • Sofia、ブルガリア、1233
        • Novartis Investigative Site
  • ベルギー
      • Bruxelles、ベルギー、1200
        • Novartis Investigative Site
      • Leuven、ベルギー、3000
        • Novartis Investigative Site
  • ポーランド
      • Chorzow、ポーランド、41-500
        • Novartis Investigative Site
      • Lodz、ポーランド、93-510
        • Novartis Investigative Site
      • Wroclaw、ポーランド、50-367
        • Novartis Investigative Site
  • ロシア連邦
      • Chelyabinsk、ロシア連邦、454076
        • Novartis Investigative Site
      • Moscow、ロシア連邦、115478
        • Novartis Investigative Site
      • St'Petersburg、ロシア連邦、197341
        • Novartis Investigative Site
      • St. Petersburg、ロシア連邦、198205
        • Novartis Investigative Site

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

18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:

  • Adults with documented diagnosis of active CLL requiring treatment
  • Bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
  • Must be refractory to fludarabine treatment
  • Age 18 yrs or older
  • At least 2 prior therapies for CLL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Signed written informed consent

Exclusion Criteria:

  • Prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
  • Treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
  • CLL transformation, prolymphocytic leukemia, or central nervous system (CNS) involvement of CLL
  • Active autoimmune hemolytic anemia (AIHA) requiring treatment except if associated with progressive disease requiring anti-CLL treatment
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
  • Human immunodeficiency virus (HIV) positive
  • Significant concurrent, uncontrolled medical condition
  • Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
  • Non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
  • Abnormal lab values: Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL or due to Gilbert's syndrome), or alanine transaminase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
  • Known or suspected hypersensitivity to ofatumumab
  • Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

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：ランダム化
  • 介入モデル：並列代入
  • 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：Ofatumumab
Biological
薬：Ofatumumab
Ofatumumab IV, initial dose 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2000 mg every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks. After 24 weeks of ofatumumab treatment, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 1) an additional ofatumumab dose regimen of 2000 mg once every 4 weeks for up to an additional 24 weeks, or 2) no further therapy (i.e. observation only).
アクティブコンパレータ：Physicians' Choice
Physicians' choice of treatment
薬：Physicians' Choice
Non-ofatumumab containing regimen as per physicians' choice for up to 6 months. Permitted therapies include treatments approved for CLL, and well established standards of care for CLL.

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
Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
時間枠：From the randomization date up to 60 months post the randomization date.
PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.
From the randomization date up to 60 months post the randomization date.

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression-free Survival (PFS) as Assessed by Investigator
時間枠：From the randomization date up to 60 months post the randomization date.
PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.
From the randomization date up to 60 months post the randomization date.
Overall Response Rate (ORR) as Assessed by the IRC
時間枠：From the randomization date up to 60 months post the randomization date.
ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.
From the randomization date up to 60 months post the randomization date.
Overall Response Rate (ORR) as Assessed by the Investigator
時間枠：From the randomization date up to 60 months post the randomization date.
ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.
From the randomization date up to 60 months post the randomization date.
Overall Survival
時間枠：From the randomization date up to 60 months post the randomization date.
Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.
From the randomization date up to 60 months post the randomization date.
Time to Progression as Assessed by IRC
時間枠：From the randomization date up to 60 months post the randomization date.
Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.
From the randomization date up to 60 months post the randomization date.
Time to Next Anti-cancer Therapy by Investigator
時間枠：From the randomization date up to 60 months post the randomization date.
Time to next therapy is defined as the time from randomization until the start of the next line of treatment.
From the randomization date up to 60 months post the randomization date.
Time to Response as Assessed by the IRC
時間枠：From the randomization date up to 60 months post the randomization date.
Time to response is defined as the time from randomization to the first response (Complete Remission[CR], Complete Remission with incomplete bone marrow recovery[CRi], partial response[PR], or nodular PR[nPR]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.
From the randomization date up to 60 months post the randomization date.
Duration of Response as Assessed by the IRC
時間枠：From the randomization date up to 60 months post the randomization date.
DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.
From the randomization date up to 60 months post the randomization date.
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
時間枠：From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.
From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
Number of Participants With Any Adverse Event (AE) of Special Interest
時間枠：From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
AEs of special interest included cytopenias (neutropenia [decreased neutrophil count], anaemia [decreased hemoglobin], and thrombocytopenia [decreased platelet count]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.
From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
時間枠：Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU), 36 Month Follow-up (36M FU), 42 Month Follow-up (42M FU). A cycle is defined as the time between one round of treatment until the start of the next round.
Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
時間枠：From the randomization date up to 60 months post the randomization date.
The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.
From the randomization date up to 60 months post the randomization date.
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
時間枠：From the randomization date up to 60 months post the randomization date.
The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) - and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.
From the randomization date up to 60 months post the randomization date.
Mean Health Change Questionnaire (HCQ) Score
時間枠：From the randomization date up to 60 months post the randomization date.
The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..
From the randomization date up to 60 months post the randomization date.

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

Novartis Pharmaceuticals

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 (実際)

2011年4月14日

一次修了 (実際)

2014年3月18日

研究の完了 (実際)

2017年4月24日

試験登録日

最初に提出

2011年3月10日

QC基準を満たした最初の提出物

2011年3月11日

最初の投稿 (見積もり)

2011年3月14日

学習記録の更新

投稿された最後の更新 (実際)

2018年11月8日

QC基準を満たした最後の更新が送信されました

2018年10月9日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 114242

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

購読する