| Primary | Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B | | Pharmacokinetics (PK) population included all participants that received at least one dose of 1000 mg TL011 or MabThera and had sufficient plasma concentration results to allow estimation of PK parameters | Posted | | Geometric Mean | Standard Deviation | Day*micrograms per milliliter | | Day 1 to Day 57 | | | | ID | Title | Description |
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| OG000 | Double Blind TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Double Blind MabThera 1000 mg | Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0007571± 2219
- OG0018377± 2879
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment. | 0.4265 | | Geometric mean ratio | 0.930 | | | 2-Sided | 90 | 0.797 | 1.084 | | | TL011 arm is the numerator and MabThera arm is the denominator | | Equivalence | Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33 | |
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| Secondary | Maximum Observed Concentration (Cmax) in Part B | | Pharmacokinetics (PK) population included all participants that received at least one dose of 1000 mg TL011 or MabThera and had sufficient plasma concentration results to allow estimation of PK parameters | Posted | | Geometric Mean | Standard Deviation | Micrograms per milliliter | | Day 1 to Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Double Blind TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Double Blind MabThera 1000 mg | Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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| Secondary | Number of Participants With Adverse Events in Part B | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring after the first dose of the study drug until 120 days after the last dose of study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety analysis set included all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | From randomization up to Week 24 | | | | ID | Title | Description |
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| OG000 | Double Blind TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Double Blind MabThera 1000 mg | Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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| Secondary | Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B | | Pharmacokinetics (PK) population included all participants that received at least one dose of 1000 mg TL011 or MabThera and had sufficient plasma concentration results to allow estimation of PK parameters. Here, "number analyzed" signifies participants evaluable for this outcome measure. Numbers analyzed were not equal at each time point (C1max and C2max). | Posted | | Geometric Mean | Standard Deviation | Micrograms per milliliter | | Day 1, Day 15 | | | | ID | Title | Description |
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| OG000 | Double Blind TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Double Blind MabThera 1000 mg | Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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| Secondary | AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B | | Pharmacokinetics (PK) population included all participants that received at least one dose of 1000 mg TL011 or MabThera and had sufficient plasma concentration results to allow estimation of PK parameters. Here, "number analyzed" signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | Day*micrograms per milliliter | | Day 1, Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Double Blind TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Double Blind MabThera 1000 mg | Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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| Secondary | Percent Change From Baseline in CD19+ B-cell Count in Part B | | PK population. Here, "number analyzed" signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percent change | | Baseline to Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Double Blind TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Double Blind MabThera 1000 mg | Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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| Secondary | Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B | Defined as at least 20% improvement from the screening values in swollen and tender joint count and in 3 of the following 5 disease activity measures.
- Physician's global assessment of disease activity (VAS)
- Patient's assessment of RA pain (VAS)
- Patient's global assessment of disease activity
- Patient's assessment of physical function (Health Assessment Questionnaire)
- Acute phase reactant (C-reactive protein [CRP])
| Intent to Treat (ITT) population included all randomized participants regardless of the treatment actually received. | Posted | | Count of Participants | | Participants | | Baseline to Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Double Blind TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Double Blind MabThera 1000 mg | Participants were administered 1000 mg of MabThera, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2 | Data available for cohort 2 only per planned analysis. | Pharmacokinetics (PK) population included all participants that received at least one dose of 1000 mg TL011 and had sufficient plasma concentration results to allow estimation of PK parameters. | Posted | | Geometric Mean | Standard Deviation | Day*micrograms per milliliter | | Day 1 to Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2 TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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| Secondary | Number of Participants With Adverse Events in Part A | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring after the first dose of the study drug until 120 days after the last dose of study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety analysis set included all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | From randomization up to Week 24 | | | | ID | Title | Description |
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| OG000 | Cohort 1 TL011 500 mg | Participants were administered 500 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). | | OG001 | Cohort 2 TL011 1000 mg | Participants were administered 1000 mg of TL011, via intravenous (IV) infusion, two weeks apart (on Day 1 and on Day 15). |
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