Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04928573
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2021-05-28
Brief Title:
Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab
Sponsor:
Libbs Farmacêutica LTDA
Organization:
Libbs Farmacêutica LTDA
Study Overview
Official Title:
Retrospective Observational Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab a Subanalysis of the RTXM83-AC-01-11 Trial
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The RTXM83-AC-01-11 study evaluated efficacy and safety outcomes in relation to the use of Vivaxxia during 6 treatment cycles at the investigators discretion up to 8 treatment cycles could be administered followed by 9 months of follow-up this follow-up time being sufficient for the analysis of non-inferiority in relation to the reference medicine However data on late events of efficacy and safety are of great value to contribute to a robust clinical response and to strengthen confidence in the use of biosimilar medicines For this reason Libbs Farmacêutica proposes this retrospective observational study to collect data on late outcomes of the pivotal study that directed the approval of the biosimilar rituximab Vivaxxia from the research participants from Brazil
The present retrospective observational study LB2002 will sub-analyze selected results of efficacy and safety from study RTXM83-AC-01-11 in participants over 18 years of age randomized in Brazil totaling 28 participants in addition to evaluating late efficacy and safety outcomes Information on subsequent treatment protocol should also be collected for participants who have progressive or recurrent disease instituted by research centers under these conditions
The proposal is to compare descriptively the selected outcomes of efficacy and safety of these participants with the same outcomes selected for the global population in the RTXM83-AC-01-11 study and also provide late safety and effective data important for anti-neoplastic processes
The present retrospective observational study LB2002 will sub-analyze selected results of efficacy and safety from study RTXM83-AC-01-11 in participants over 18 years of age randomized in Brazil totaling 28 participants in addition to evaluating late efficacy and safety outcomes Information on subsequent treatment protocol should also be collected for participants who have progressive or recurrent disease instituted by research centers under these conditions
The proposal is to compare descriptively the selected outcomes of efficacy and safety of these participants with the same outcomes selected for the global population in the RTXM83-AC-01-11 study and also provide late safety and effective data important for anti-neoplastic processes
Detailed Description:
Evaluate research participants who were refractory to treatment defined as not having achieved Complete Response CR or Partial Response PR after 6 treatment cycles in study RTXM83-AC-01-11
Evaluate the participants who had a recurrence of the disease defined as a change from Complete Response CR after 06 treatment cycles in study RTXM83-AC-01-11 to Progressive Disease PD until the date of consent ICF in the LB2002 study
The data of the subsequent treatment protocol instituted by the research center for progressive or recurrent disease will also be collected
PERIOD OF ANALYSIS OF THIS CLINICAL STUDY
01-JUL-2013 beginning of the study to 17-JUL-2017 data in which the last participant of the study RTXM83-AC-01-11 arrived at the last follow-up visit at 9 months after the last dose of treatment for sub-analysis of efficacy and safety proposed by study RTXM83-AC-01-11 SLE TRG and EA and for exploratory evaluation of refractory disease
Data from randomization in study RTXM83-AC-01-11 to consent data TCLE in study LB2002 for analysis of SLP SG and for exploratory evaluation of relapse
Date of the final visit of study RTXM83-AC-01-11 considered as FUP3 until the date of consent ICF in study LB2002 for the evaluation of late AEs of interest
Data collectFor the subanalysis evaluations the data that have already been collected will be used and are part of the study database RTXM83-AC-01-11 This database will also be considered for exploratory assessment of refractory disease
For late evaluations of safety and efficacy late adverse events of interest SLP SG and disease recurrence and also data on the subsequent treatment protocol instituted by the research center for progressive disease or disease recurrence data from medical records available at research centers
Finally all the data necessary to evaluate the objectives established in this study will be imputed in a single Electronic Case Report Form eCRF developed exclusively for this project
Evaluate the participants who had a recurrence of the disease defined as a change from Complete Response CR after 06 treatment cycles in study RTXM83-AC-01-11 to Progressive Disease PD until the date of consent ICF in the LB2002 study
The data of the subsequent treatment protocol instituted by the research center for progressive or recurrent disease will also be collected
PERIOD OF ANALYSIS OF THIS CLINICAL STUDY
01-JUL-2013 beginning of the study to 17-JUL-2017 data in which the last participant of the study RTXM83-AC-01-11 arrived at the last follow-up visit at 9 months after the last dose of treatment for sub-analysis of efficacy and safety proposed by study RTXM83-AC-01-11 SLE TRG and EA and for exploratory evaluation of refractory disease
Data from randomization in study RTXM83-AC-01-11 to consent data TCLE in study LB2002 for analysis of SLP SG and for exploratory evaluation of relapse
Date of the final visit of study RTXM83-AC-01-11 considered as FUP3 until the date of consent ICF in study LB2002 for the evaluation of late AEs of interest
Data collectFor the subanalysis evaluations the data that have already been collected will be used and are part of the study database RTXM83-AC-01-11 This database will also be considered for exploratory assessment of refractory disease
For late evaluations of safety and efficacy late adverse events of interest SLP SG and disease recurrence and also data on the subsequent treatment protocol instituted by the research center for progressive disease or disease recurrence data from medical records available at research centers
Finally all the data necessary to evaluate the objectives established in this study will be imputed in a single Electronic Case Report Form eCRF developed exclusively for this project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None