Trial Outcomes & Findings for A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products (NCT NCT04268771)
NCT ID: NCT04268771
Last Updated: 2023-11-18
Results Overview
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
ADA will be obtained before the administration of study treatment on Day 1
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Arm A: DRL_RI
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
66
|
68
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Participants
Baseline characteristics by cohort
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Study Participants
|
0 Participants
n=7 Participants • Study Participants
|
0 Participants
n=5 Participants • Study Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants • Study Participants
|
39 Participants
n=7 Participants • Study Participants
|
86 Participants
n=5 Participants • Study Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants • Study Participants
|
31 Participants
n=7 Participants • Study Participants
|
54 Participants
n=5 Participants • Study Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
09 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Time from prior rituximab
|
7.5 months
STANDARD_DEVIATION 2.65 • n=5 Participants
|
7.6 months
STANDARD_DEVIATION 2.85 • n=7 Participants
|
7.6 months
STANDARD_DEVIATION 2.77 • n=5 Participants
|
PRIMARY outcome
Timeframe: ADA will be obtained before the administration of study treatment on Day 1For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
Outcome measures
| Measure |
Arm A: DRL_RI
n=69 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=68 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 1
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: ADA will be obtained before the administration of study treatment on Day 15For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 15 was reported
Outcome measures
| Measure |
Arm A: DRL_RI
n=69 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=68 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 15
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: ADA will be obtained before the administration of study treatment at Week 4For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 4 was reported
Outcome measures
| Measure |
Arm A: DRL_RI
n=69 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=68 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: ADA will be obtained before the administration of study treatment at Week 8For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 8 was reported
Outcome measures
| Measure |
Arm A: DRL_RI
n=69 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=68 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 8
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: ADA will be obtained at Week 12For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 12 visits was reported
Outcome measures
| Measure |
Arm A: DRL_RI
n=69 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=68 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 12 Visits
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessments of Anaphylactic reactions will be carried out at either Week 1 or Week 3Population: Safety population
Number of Subjects reporting anaphylactic reactions during the study drug administration either at Week 1 or Week 3 was reported
Outcome measures
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects Reporting Anaphylactic Reactions at Dosing Time Points (Either at Week 1 or Week 3)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessment of AE's (Adverse Events) that led to study drug discontinuation were carried out at either week 1 or week 3 dosing timepointPopulation: Safety population
TEAEs (Treatment emergent adverse events) which lead to study subjects discontinuation from the study drug administration at either week 1 or week 3 dosing timepoint
Outcome measures
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects Reporting TEAEs (Treatment Emergent Adverse Events) That Led to Study Drug Discontinuation at Either Week 1 or Week 3 Dosing Timepoint
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessment of SAE's was carried out from baseline (week 1) to end of study (week 26)Population: Safety population
Incidence of SAEs: SAE is defined as "Results in death, is life-threatening, Requires in-subject hospitalization or prolongs existing hospitalization, Results in persistent or significant disability/incapacity". The measure here is only subjects reporting SAE.
Outcome measures
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects Reporting SAEs (Serious Adverse Events) From Baseline (Week 1) to End of Study (Week 26)
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)Population: Safety population
Number of TEAEs: Treatment-emergent AE are defined as any AE occurring or worsening on or after the first dose of study medication.
Outcome measures
| Measure |
Arm A: DRL_RI
n=37 Events
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=54 Events
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of TEAEs Reported From Baseline (Week 1) to End of Study (Week 26)
|
35 Number of events
|
54 Number of events
|
SECONDARY outcome
Timeframe: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)Population: Safety population
number of subjects reporting AE in the overall study are defined as any AE occurring or worsening after the ICF signed in the study
Outcome measures
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects Reporting AE From Baseline (Week 1) to End of Study (Week 26)
|
24 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)Population: Safety population
Number of subjects reporting Treatment-emergent AE (TEAEs) are defined as any AE occurring or worsening on or after the first dose of study medication.
Outcome measures
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects Reporting TEAEs From Baseline (Week 1) to End of Study (Week 26)
|
24 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Assessments of hypersensitivity reactions either at Week 1 or Week 3Safety assessment will be done by measuring hypersensitivity reactions at Dosing Time Points (Either at Week 1 or Week 3)
Outcome measures
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects Reporting Hypersensitivity Reactions at Dosing Time Points (Either at Week 1 or Week 3)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Assessments of IRRs were carried out at either Week 1 or Week 3Population: Safety population
Safety assessment: Number of Subjects Reporting Infusion-related reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3) was reported
Outcome measures
| Measure |
Arm A: DRL_RI
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 Participants
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Number of Subjects Reporting Infusion-related Reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3)
|
2 participants
|
0 participants
|
Adverse Events
Arm A: DRL_RI
Serious events: 4 serious events
Other events: 3 other events
Deaths: 4 deaths
Arm B: US-Rituximab or EU-Rituximab
Serious events: 2 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A: DRL_RI
n=70 participants at risk
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 participants at risk
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/70 • Number of events 1 • Till week 26
|
0.00%
0/70 • Till week 26
|
|
Surgical and medical procedures
Intestinal resection
|
1.4%
1/70 • Number of events 1 • Till week 26
|
0.00%
0/70 • Till week 26
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/70 • Till week 26
|
1.4%
1/70 • Number of events 1 • Till week 26
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/70 • Till week 26
|
1.4%
1/70 • Number of events 1 • Till week 26
|
|
Infections and infestations
COVID-19 Pneumonia
|
2.9%
2/70 • Number of events 2 • Till week 26
|
0.00%
0/70 • Till week 26
|
|
Infections and infestations
Cystitis
|
0.00%
0/70 • Till week 26
|
1.4%
1/70 • Number of events 1 • Till week 26
|
|
Infections and infestations
Empyema
|
0.00%
0/70 • Till week 26
|
1.4%
1/70 • Number of events 1 • Till week 26
|
|
Infections and infestations
Septic Shock
|
0.00%
0/70 • Till week 26
|
1.4%
1/70 • Number of events 1 • Till week 26
|
Other adverse events
| Measure |
Arm A: DRL_RI
n=70 participants at risk
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15
Experimental: Arm A: DRL\_RI: Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
|
Arm B: US-Rituximab or EU-Rituximab
n=70 participants at risk
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively.
Arm B: Rituxan®/Mabthera®: Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Till week 26
|
7.1%
5/70 • Number of events 5 • Till week 26
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/70 • Number of events 2 • Till week 26
|
7.1%
5/70 • Number of events 5 • Till week 26
|
|
Infections and infestations
COVID-19
|
1.4%
1/70 • Number of events 1 • Till week 26
|
5.7%
4/70 • Number of events 4 • Till week 26
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/70 • Till week 26
|
4.3%
3/70 • Number of events 3 • Till week 26
|
Additional Information
Head-Clinical Development
Dr. Reddy's Laboratories Ltd.
Phone: 91-40-4464-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60