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Fordeler med individuell fysisk aktivitetsintervensjon på helserelatert livskvalitet hos deltakere med kronisk lymfatisk leukemi (QOLIBRI)

2. november 2026 oppdatert av: Janssen Cilag S.A.S.

Fordeler med individuell fysisk aktivitetsintervensjon på helserelatert livskvalitet hos pasienter med kronisk lymfatisk leukemi som får Ibrutinib i praksis

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Rekruttering

Forhold

Forhold

Sykdommen, lidelsen, syndromet, sykdommen eller skaden som studeres. På ClinicalTrials.gov kan tilstander også inkludere andre helserelaterte problemer, som levetid, livskvalitet og helserisiko.

Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.

Studietype

Studietype

Beskriver arten av en klinisk studie. Studietyper inkluderer intervensjonsstudier (også kalt kliniske studier), observasjonsstudier (inkludert pasientregistre) og utvidet tilgang.
Observasjonsmessig

Registrering (Antatt)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
180

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiekontakt

Navn og kontaktinformasjon for personen som kan svare på påmeldingsspørsmål for en klinisk studie. Hvert sted hvor studien gjennomføres kan også ha en spesifikk kontakt, som kan være bedre i stand til å svare på disse spørsmålene.

Studiesteder

  • Frankrike
      • Toulouse, Frankrike, 31059
        • Rekruttering
        • Institut Universitaire du Cancer Toulouse Oncopole

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Kvalifikasjonskriterier

Nøkkelkravene som personer som ønsker å delta i en klinisk studie må oppfylle eller egenskapene de må ha. Kvalifikasjonskriterier består av både inklusjonskriterier (som kreves for at en person skal delta i studien) og eksklusjonskriterier (som hindrer en person i å delta). Typer kvalifikasjonskriterier inkluderer om en studie godtar friske frivillige, har alders- eller aldersgruppekrav, eller er begrenset av kjønn.

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL).

Beskrivelse

Inclusion Criteria:

  • Participants newly treated with ibrutinib for first line or relapsed CLL (treatment is being initiated or has been initiated within the last 8 days as a maximum)
  • Participants agreed to follow the individual physical activity intervention (IPAI)
  • Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet
  • Participants with Internet access at home and email address
  • Participants agreed to wear a connected watch 24 hours a day for all the duration of the study

Exclusion Criteria:

  • Pregnant participants or planning to become pregnant while enrolled in this study
  • Participants with inability or deemed unsafe to practice physical activity
  • Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit
  • Participants who are currently involved in an interventional study
  • Participants with probable difficulties in using the digital tool autonomously

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort

Gruppe / Kohort

En gruppe eller undergruppe av deltakere i en observasjonsstudie som vurderes for biomedisinske eller helsemessige utfall.
Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Group 1: Individual Physical Activity Intervention

Participants with chronic lymphocytic leukemia (CLL) will be invited to perform physical activity according to a predefined intervention program. This program includes walking and weekly remote adapted physical activity sessions (2 sessions per week, the duration and difficulty of which will be adapted by the adapted physical activity [APA] trainer according to the Participant's abilities).
Atferdsmessig: Individual Physical Activity Intervention (IPAI)

No drug will be administered as a part of this study. The intervention will consist in an IPAI provided to participants for 6 months to practice physical activity in addition to their medical treatment in routine clinical practice settings. IPAI will be an adaptive program and will comprise two periods, the first period consisting in a supervised 4-month program and the second one in an unsupervised 2-month program to achieve greater autonomy.

Legemiddel: Ibrutinib

No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.
Group 2: Standard of Care

Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.
Legemiddel: Ibrutinib

No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.

Hva måler studien?

Primære resultatmål

Primære resultatmål

I en klinisk studies protokoll er det planlagte utfallsmålet som er det viktigste for å evaluere effekten av en intervensjon/behandling. De fleste kliniske studier har ett primært utfallsmål, men noen har mer enn ett.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5
Tidsramme: Baseline and Month 4.5

The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Baseline and Month 4.5

Sekundære resultatmål

Sekundære resultatmål

I en klinisk studies protokoll, et planlagt utfallsmål som ikke er like viktig som det primære utfallsmålet for å evaluere effekten av en intervensjon, men som fortsatt er av interesse. De fleste kliniske studier har mer enn ett sekundært utfallsmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Baseline, Month 4.5, Month 6.5, and Month 12
Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5
Tidsramme: Month 4.5 and Month 6.5

The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12
Tidsramme: Month 6.5 and Month 12

The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Month 6.5 and Month 12
Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Baseline, Month 4.5, Month 6.5, and Month 12
Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5
Tidsramme: Month 4.5 and Month 6.5

The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12
Tidsramme: Month 6.5 and Month 12

The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Month 6.5 and Month 12
Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12
Tidsramme: Baseline, Month 6.5, and Month 12

The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Baseline, Month 6.5, and Month 12
Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5
Tidsramme: Month 4.5 and Month 6.5

The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12
Tidsramme: Month 6.5 and Month 12

The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Month 6.5 and Month 12
Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Baseline, Month 4.5, Month 6.5, and Month 12
Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

The FACIT-fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Time Using Connected Watch
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

Change from baseline in total sleep time (in hours) using connected watch will be assessed.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Score Using Connected Watch
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

Change from baseline in total sleep score (time asleep/time in bed) based on duration, regularity, depth and interruption using connected watch will be assessed.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Sleep Stages Using Connected Watch
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

Change from baseline in sleep stages (deep/light) using connected watch will be assessed.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

The HAD scale is a 14-items measure that assesses anxiety and depressive disorders. The scale includes seven questions related to anxiety (total A) and seven others to the depressive dimension (total D). Each item is rated from 0 to 3. Two scores are derived from the scale, one related to anxiety and the other related to depression (maximum score for each score = 21). Higher scores indicate increased anxiety or depression.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. It is easy to administer, better tolerated, and more reflective of activities of daily living than the other walk tests.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

Change from baseline in physical activity as assessed by number of steps per day using connected watch will be reported.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

Change from baseline in physical activity as assessed by the number of walking sessions per week using connected watch will be reported.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

Change from baseline in physical activity as assessed by the time of walking sessions per week using connected watch will be reported.
Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch
Tidsramme: Baseline, Month 4.5, Month 6.5, and Month 12

Change from baseline in physical activity as assessed by the distance of walking sessions per week using connected watch will be reported.
Baseline, Month 4.5, Month 6.5, and Month 12
Percentage of Participants with Treatment-related Adverse Events
Tidsramme: Up to 30 months

Percentage of participants with treatment-related adverse events especially musculoskeletal and cardiovascular treatment-related adverse events will be reported.
Up to 30 months
Time to Treatment Discontinuation (TTD)
Tidsramme: Months 6 and 12

TTD is defined as the time between the first day of ibrutinib treatment and the day that ibrutinib is definitely stopped for whatever reason or death.
Months 6 and 12
Reasons for Treatment Discontinuation
Tidsramme: Up to Month 12

Number of participants in each reason for treatment discontinuation will be reported. Reasons for treatment discontinuation are defined as: adverse events, lack of efficacy, patient's convenience, physician's decision, progression, death or other.
Up to Month 12
Percentage of Participants Who Still Wear the Connected Watch
Tidsramme: Months 1, 3, 4.5, 6.5, and 12

Percentage of participants who still wear the connected watch (adherence) will be assessed.
Months 1, 3, 4.5, 6.5, and 12
Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)
Tidsramme: Months 1, 3, 4.5, 6.5, and 12

Percentage of participants retained by the connected watch (start wearing the watch) will be assessed.
Months 1, 3, 4.5, 6.5, and 12
Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment
Tidsramme: During the first 6 months (Feasibility period)

Percentage of participants agreed to participate in the study among eligible participants with CLL initiation ibrutinib treatment will be reported.
During the first 6 months (Feasibility period)
For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI
Tidsramme: Months 1, 3, 4.5, and 6.5

Percentage of participants who still follow the IPAI among those who have started IPAI (Adherence) in group 1 will be assessed.
Months 1, 3, 4.5, and 6.5
For Group 1: Percentage of Participants Who Follow the Adapted Physical Activity (APA) Sessions, the Walking Objectives and the APA Appointment as Scheduled With the APA Among Those Who Have Started IPAI
Tidsramme: Months 1, 3, 4.5, and 4.6

Percentage of participants who follow the adapted physical activity sessions, the walking objectives and the APA appointment as scheduled with the APA among those who have started IPAI (Compliance) in group 1 will be assessed.
Months 1, 3, 4.5, and 4.6
For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study
Tidsramme: Months 1 and 3

Percentage of participants retained by the IPAI (first APA videoconference attended) among participants enrolled in the study will be assessed.
Months 1 and 3
For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study
Tidsramme: Month 4.5

Percentage of participants who completed the supervised period among participants enrolled in the study will be assessed.
Month 4.5
For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study
Tidsramme: Month 6.5

Percentage of participants who completed the unsupervised period among participants enrolled in the study will be assessed.
Month 6.5
For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale
Tidsramme: Months 4.5, 6.5, and 12

Participant's' satisfaction will be assessed by Likert scales at Months 4.5 and 6.5 regarding coaching, proposed sessions, program content, program duration, impact on APA practice, overall satisfaction, willingness to continue and recommendation to others. Likert scales will assess participant's' satisfaction at Month 12 regarding impact on APA practice, overall satisfaction, willingness to continue and recommendation to others. Only one question is quantitative with score range from 0 (not at all satisfied) to 10 (totally satisfied) for global satisfaction. Participants are considered satisfied when score is greater than or equal to (>=) 6 and highly-satisfied when score is >=8. All other questions are qualitative and have 5-level Likert scales including: very satisfied, rather satisfied, neither satisfied nor dissatisfied, not really satisfied, not at all satisfied.
Months 4.5, 6.5, and 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sponsor

Organisasjonen eller personen som initierer studien og som har myndighet og kontroll over studien.
Janssen Cilag S.A.S.

Etterforskere

Etterforskere

En forsker involvert i en klinisk studie. Beslektede termer inkluderer stedets hovedetterforsker, stedsunderetterforsker, studieleder, studieleder og studiehovedetterforsker.
  • Studieleder: Janssen Cilag S.A.S., France Clinical Trial, Janssen Cilag S.A.S.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

Studiestart

Den faktiske datoen da den første deltakeren ble registrert i en klinisk studie. Den "forventede" studiestartdatoen er datoen som forskerne tror vil være studiestartdatoen.
27. mai 2024

Primær fullføring (Antatt)

Primær fullføring

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon for å samle inn endelige data for det primære utfallsmålet. Hvorvidt den kliniske studien ble avsluttet i henhold til protokollen eller ble avsluttet, påvirker ikke denne datoen. For kliniske studier med mer enn ett primært utfallsmål med ulike fullføringsdatoer, refererer dette begrepet til datoen da datainnsamlingen er fullført for alle de primære utfallsmålene. Den "forventede" primære fullføringsdatoen er datoen som forskerne tror vil være den primære fullføringsdatoen for studien.
30. oktober 2026

Studiet fullført (Antatt)

Studiet fullført

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon/behandling for å samle inn endelige data for de primære utfallsmålene, sekundære utfallsmålene og uønskede hendelsene (det vil si siste deltakers siste besøk). Den "forventede" studiens fullføringsdato er datoen som forskerne tror vil være studiens fullføringsdato.
30. november 2027

Datoer for studieregistrering

Først innsendt

Først innsendt

Datoen da studiesponsoren eller etterforskeren først sendte inn en studiepost til ClinicalTrials.gov. Det er vanligvis en forsinkelse på noen dager mellom første innsendte dato og postens tilgjengelighet på ClinicalTrials.gov (den første postedatoen).
1. mars 2024

Først innsendt som oppfylte QC-kriteriene

Først innsendt som oppfylte QC-kriteriene

Datoen da studiesponsoren eller etterforskeren først sender inn en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Sponsoren eller etterforskeren må kanskje revidere og sende inn en studiepost én eller flere ganger før NLMs kvalitetskontrollkriterier oppfylles. Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
1. mars 2024

Først lagt ut (Faktiske)

Først lagt ut

Datoen da studieposten først var tilgjengelig på ClinicalTrials.gov etter at National Library of Medicine (NLM) kvalitetskontroll (QC) gjennomgang har konkludert. Det er vanligvis en forsinkelse på noen dager mellom datoen studiesponsoren eller etterforskeren sendte inn studieposten og den første postedatoen.
8. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Sist oppdatering lagt ut

Den siste datoen da endringer i en studiepost ble gjort tilgjengelig på ClinicalTrials.gov. Det kan være en forsinkelse mellom når endringene ble sendt til ClinicalTrials.gov av studiens sponsor eller etterforsker (datoen for siste innsending av oppdatering) og datoen for siste oppdatering.
3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Den siste datoen da studiesponsoren eller etterforskeren sendte inn endringer i en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
2. november 2026

Sist bekreftet

Sist bekreftet

Den siste datoen da studiesponsoren eller etterforskeren bekreftet at informasjonen om en klinisk studie på ClinicalTrials.gov var nøyaktig og oppdatert. Hvis en studie med rekrutteringsstatus for rekruttering; ikke rekrutterer ennå; eller aktiv, ikke rekruttering har ikke blitt bekreftet de siste 2 årene, studiens rekrutteringsstatus vises som ukjent.
1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Andre studie-ID-numre

Identifikatorer eller ID-numre andre enn NCT-nummeret som er tildelt en klinisk studie av studiens sponsor, finansierere eller andre. Disse tallene kan inkludere unike identifikatorer fra andre prøveregistre og National Institutes of Health-stipendnumre.
  • 54179060CLL4033
  • 54179060CLL4033 (Annen identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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