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

9. října 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

122

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Belgie
      • Bruxelles, Belgie, 1200
        • Novartis Investigative Site
      • Leuven, Belgie, 3000
        • Novartis Investigative Site
  • Bulharsko
      • Sofia, Bulharsko, 1431
        • Novartis Investigative Site
      • Sofia, Bulharsko, 1407
        • Novartis Investigative Site
      • Sofia, Bulharsko, 1233
        • Novartis Investigative Site
  • Francie
      • Bobigny cedex, Francie, 93009
        • Novartis Investigative Site
      • Brest cedex, Francie, 29609
        • Novartis Investigative Site
      • Clermont-Ferrand Cedex 1, Francie, 63003
        • Novartis Investigative Site
      • Creteil cedex, Francie, 94010
        • Novartis Investigative Site
      • Lille cedex, Francie, 59037
        • Novartis Investigative Site
      • Rennes cedex 9, Francie, 35033
        • Novartis Investigative Site
      • Toulouse cedex 9, Francie, 31059
        • Novartis Investigative Site
      • Tours cedex 9, Francie, 37044
        • Novartis Investigative Site
  • Irsko
      • Dublin, Irsko, 7
        • Novartis Investigative Site
      • Galway, Irsko
        • Novartis Investigative Site
      • James Street, Irsko, 8
        • Novartis Investigative Site
  • Itálie
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Itálie, 41124
        • Novartis Investigative Site
    • Lombardia
      • Brescia, Lombardia, Itálie, 25123
        • Novartis Investigative Site
      • Milano, Lombardia, Itálie, 20162
        • Novartis Investigative Site
      • Milano, Lombardia, Itálie, 20132
        • Novartis Investigative Site
    • Piemonte
      • Torino, Piemonte, Itálie, 10126
        • Novartis Investigative Site
    • Sicilia
      • Messina, Sicilia, Itálie, 95158
        • Novartis Investigative Site
  • Izrael
      • Jerusalem, Izrael, 91120
        • Novartis Investigative Site
      • Ramat Gan, Izrael, 52621
        • Novartis Investigative Site
  • Maďarsko
      • Budapest, Maďarsko, 1097
        • Novartis Investigative Site
      • Debrecen, Maďarsko, 4012
        • Novartis Investigative Site
      • Pecs, Maďarsko, 7624
        • Novartis Investigative Site
      • Szombathely, Maďarsko, 9700
        • Novartis Investigative Site
  • Německo
    • Bayern
      • Kronach, Bayern, Německo, 96317
        • Novartis Investigative Site
      • Regensburg, Bayern, Německo, 93053
        • Novartis Investigative Site
    • Brandenburg
      • Frankfurt/Oder, Brandenburg, Německo, 15236
        • Novartis Investigative Site
    • Hessen
      • Frankfurt, Hessen, Německo, 60590
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Německo, 45122
        • Novartis Investigative Site
      • Koeln, Nordrhein-Westfalen, Německo, 50937
        • Novartis Investigative Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Německo, 56068
        • Novartis Investigative Site
    • Sachsen
      • Chemnitz, Sachsen, Německo, 09113
        • Novartis Investigative Site
      • Dresden, Sachsen, Německo, 01307
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Německo, 39130
        • Novartis Investigative Site
  • Polsko
      • Chorzow, Polsko, 41-500
        • Novartis Investigative Site
      • Lodz, Polsko, 93-510
        • Novartis Investigative Site
      • Wroclaw, Polsko, 50-367
        • Novartis Investigative Site
  • Rakousko
      • Graz, Rakousko, 8036
        • Novartis Investigative Site
      • Innsbruck, Rakousko, 6020
        • Novartis Investigative Site
      • Linz, Rakousko, 4020
        • Novartis Investigative Site
      • Salzburg, Rakousko, A-5020
        • Novartis Investigative Site
      • Wien, Rakousko, 1140
        • Novartis Investigative Site
  • Ruská Federace
      • Chelyabinsk, Ruská Federace, 454076
        • Novartis Investigative Site
      • Moscow, Ruská Federace, 115478
        • Novartis Investigative Site
      • St'Petersburg, Ruská Federace, 197341
        • Novartis Investigative Site
      • St. Petersburg, Ruská Federace, 198205
        • Novartis Investigative Site
  • Singapur
      • Singapore, Singapur, 169608
        • Novartis Investigative Site
  • Slovensko
      • Bratislava, Slovensko, 833 10
        • Novartis Investigative Site
      • Bratislava, Slovensko, 851 07
        • Novartis Investigative Site
      • Kosice, Slovensko, 041 66
        • Novartis Investigative Site
      • Martin, Slovensko, 036 59
        • Novartis Investigative Site
  • Spojené království
      • Bournemouth, Spojené království, BH7 7DW
        • Novartis Investigative Site
      • Manchester, Spojené království, M20 4BX
        • Novartis Investigative Site
      • Oxford, Spojené království, OX3 7LE
        • Novartis Investigative Site
  • Ukrajina
      • Cherkasy, Ukrajina, 18009
        • Novartis Investigative Site
      • Dnipropetrovsk, Ukrajina, 49102
        • Novartis Investigative Site
      • Donetsk, Ukrajina, 83045
        • Novartis Investigative Site
      • Kharkiv, Ukrajina, 61070
        • Novartis Investigative Site
      • Khmelnytskyi, Ukrajina, 29000
        • Novartis Investigative Site
      • Kyiv, Ukrajina, 03022
        • Novartis Investigative Site
      • Kyiv, Ukrajina, 04112
        • Novartis Investigative Site
      • Lviv, Ukrajina, 79044
        • Novartis Investigative Site
      • Makiivka, Ukrajina, 86132
        • Novartis Investigative Site
      • Simferopil, Ukrajina, 95023
        • Novartis Investigative Site
      • Vinnitsa, Ukrajina, 21018
        • Novartis Investigative Site
      • Zhytomyr, Ukrajina, 10002
        • Novartis Investigative Site
  • Česko
      • Hradec Kralove, Česko
        • Novartis Investigative Site
      • Olomouc, Česko, 775 20
        • Novartis Investigative Site
      • Praha 2, Česko, 128 08
        • Novartis Investigative Site
  • Švédsko
      • Goteborg, Švédsko, SE-413 45
        • Novartis Investigative Site
      • Linkoping, Švédsko, SE-581 85
        • Novartis Investigative Site
      • Lulea, Švédsko, SE-971 80
        • Novartis Investigative Site
      • Orebro, Švédsko, SE-701 85
        • Novartis Investigative Site
      • Stockholm, Švédsko, SE-171 76
        • Novartis Investigative Site
      • Umea, Švédsko, SE-901 85
        • Novartis Investigative Site
      • Uppsala, Švédsko, SE-751 85
        • Novartis Investigative Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Ofatumumab
Biological
Lék: 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).
Aktivní komparátor: Physicians' Choice
Physicians' choice of treatment
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free Survival (PFS) as Assessed by Investigator
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

14. dubna 2011

Primární dokončení (Aktuální)

18. března 2014

Dokončení studie (Aktuální)

24. dubna 2017

Termíny zápisu do studia

První předloženo

10. března 2011

První předloženo, které splnilo kritéria kontroly kvality

11. března 2011

První zveřejněno (Odhad)

14. března 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. listopadu 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. října 2018

Naposledy ověřeno

1. října 2018

Více informací

Termíny související s touto studií

Klíčová slova

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Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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