Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04928573 |
Other study ID # |
LB2002 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 8, 2022 |
Est. completion date |
March 23, 2023 |
Study information
Verified date |
July 2022 |
Source |
Libbs Farmacêutica LTDA |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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 investigator's 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.
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 collect:For 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.