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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05409066
Registration number
NCT05409066
Ethics application status
Date submitted
3/06/2022
Date registered
8/06/2022
Titles & IDs
Public title
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
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Scientific title
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
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Secondary ID [1]
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2021-000169-34
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Secondary ID [2]
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M20-638
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Universal Trial Number (UTN)
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Trial acronym
EPCORE FL-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma (FL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Epcoritamab
Treatment: Drugs - Rituximab
Treatment: Drugs - Lenalidomide
Experimental: Epcoritamab Dose A in Combination With R2 - Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Experimental: Epcoritamab Dose B in Combination With R2 - Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
Active comparator: Lenalidomide and Rituximab (R2) - Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Treatment: Drugs: Epcoritamab
Subcutaneous Injection
Treatment: Drugs: Rituximab
Intravenous Infusion
Treatment: Drugs: Lenalidomide
Oral Capsules
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [1]
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Percentage of Participants Achieving Complete Response (CR)
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Assessment method [1]
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Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
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Timepoint [2]
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Up to approximately 8 years from randomization
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Secondary outcome [3]
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Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
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Assessment method [3]
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MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.
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Timepoint [3]
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Up to approximately 5 years
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
* Participant has:
* Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
* >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
* Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
* Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
* Eligible to receive R2 per investigator determination.
* Estimated Creatinine Clearance (CrCl) >= 50 mL/min.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Documented refractoriness to lenalidomide.
* Have lenalidomide exposure within 12 months prior to randomization.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
16/06/2030
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital /ID# 239272 - Camperdown
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Nepean Hospital /ID# 239093 - Kingswood
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Townsville University Hospital /ID# 231124 - Douglas
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Peninsula Private Hospital /ID# 238796 - Frankston
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Fiona Stanley Hospital /ID# 231122 - Murdoch
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Hollywood Medical Centre /ID# 251789 - Nedlands
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Royal Perth Hospital /ID# 230456 - Perth
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2050 - Camperdown
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2747 - Kingswood
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4814 - Douglas
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3199 - Frankston
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6150 - Murdoch
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6009 - Nedlands
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6000 - Perth
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Gyeongsangnamdo
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Jeonrabugdo
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Seoul Teugbyeolsi
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Deventer
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Auckland
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Rio Piedras
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Barcelona
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Cordoba
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Caceres
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Madrid
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Sevilla
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Sweden
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Switzerland
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Aargau
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Switzerland
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Graubuenden
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Switzerland
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Sankt Gallen
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Ticino
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Kaohsiung
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Taichung
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Turkey
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Adana
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Turkey
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Antalya
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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United Kingdom
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Devon
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United Kingdom
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London, City Of
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United Kingdom
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Oxfordshire
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United Kingdom
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United Kingdom
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Birmingham
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United Kingdom
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Colchester
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genmab
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Commercial sector/industry
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AbbVie
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Ethics approval
Ethics application status
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Summary
Brief summary
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT05409066
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for public queries
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ABBVIE CALL CENTER
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844-663-3742
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05409066