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This study will compare the plasma pharmacokinetic profile and the change in disease activity score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be monitored for safety, B cell depletion and recovery, and for the development of immune responses to the administered study drugs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRL_RI | Experimental |
| |
| Rituxan | Active Comparator |
| |
| MabThera | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRL_RI | Biological | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 336 Hours (AUC0-336) Post First Dose | PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose. | 2 weeks |
| AUC0-∞ Over the Entire Course of Therapy (2 Doses) From Day 1 Through Week 16. | PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose. | 16 weeks |
| Area Under Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) (Second Dose). | PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) After First Dose | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) ,and 168 hours (post-EOI). | 2 weeks |
| Maximum Plasma Concentration (Cmax) After Second Dose |
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Inclusion Criteria:
Exclusion Criteria:
Prior therapy with
Other prior or concurrent therapies may also be excluded
Any clinically relevant abnormality detected on screening history, physical examination, clinical laboratory, chest X-ray, or electrocardiogram (ECG), other than values consistent with RA
Evidence of active, suspected or inadequately treated TB
Positive serological test for hepatitis C virus antibodies, hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus
History of cardiovascular disease, history of stroke, or uncontrolled hypertension
History of lymphoproliferative disease or organ allograft
History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for >5 years)
History of allergy (medication history) to any of the compounds used in the study
Pregnant or lactating women or women planning to become pregnant during the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gurunank Care Hospital | Hyderabad | Andhra Pradesh | 500020 | India | ||
| Care Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32052313 | Derived | Haridas VM, Katta R, Nalawade A, Kharkar S, Zhdan V, Garmish O, Lopez-Lazaro L, Batra SS, Kankanwadi S. Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naive Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study. BioDrugs. 2020 Apr;34(2):183-196. doi: 10.1007/s40259-020-00406-1. |
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The study was having 6 weeks screening period to accommodate 4 weeks washout/run-in stabilization and screening procedures.
The study was conducted in 2 parts, a treatment and evaluation period (Part 1) and a recovery and follow-up period (Part 2).
Study period was between November 2014 to June 2017 in a total of 29 sites across India and Ukraine.
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| ID | Title | Description |
|---|---|---|
| FG000 | DRL_RI (DRL Rituximab-Test Product Arm) | DRL_RI 500 mg/50 mL solution in a single-use vial. On Day 1, all randomized patients were received one dose of 1000 mg of assigned study drug as a slow IV infusion. The second infusion was administered on Day 15. |
| FG001 | Rituxan® (US Licensed Reference Product) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment and Evaluation |
|
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| Rituxan |
| Biological |
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
|
|
| MabThera | Biological | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
|
|
Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI),6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), and 336 hours post EOI. |
| 2 weeks |
| Time to Cmax (Tmax) After First Dose. | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , and 168 hours (post-EOI). | 2 weeks |
| Time to Cmax (Tmax) After Second Dose | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , and 168 hours (post-EOI). | 2 weeks |
| Volume of Distribution (Vz) | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion. | 24 weeks |
| Systemic Clearance (CL) | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion. | 24 weeks |
| Terminal Half-life (t1/2) | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion. | 24 weeks |
| Mean Change in Disease Activity Score-C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Weeks 4 | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 4 weeks minus baseline value). | Baseline and 4 weeks |
| Mean Change in DAS28-CRP From Baseline Per Unit Time at 8 Weeks. | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 8 weeks minus baseline value). | Baseline and 8 weeks |
| Mean Change in DAS28-CRP From Baseline Per Unit Time at Week 12. | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 12 weeks minus baseline value). | Baseline and 12 weeks |
| Mean Change in Disease Activity Score- C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Week 16. | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 16 weeks minus baseline value). | Baseline and 16 weeks |
| Percentage of Patients With B-cell Counts 20% Below the Lower Limit of Normal | The time to depletion and repletion of peripheral blood cell counts (determined by CD19+ cell counts) as well as the B-cell counts at selected time points (taking into consideration the patient baseline count) were used to assess the PD of the study drugs. | 48 hours |
| Percentage of Patients With Peripheral B-cell Counts Depletion at Week 16. | Analysis of the PD parameter peripheral B-Cell count was performed by evaluating the 95% CI for the difference between treatment arms in the percentage of patients with B-cell depletion at 48 hours after dose 1, Week 16, and at Week 24. Percentage of patients with B-cell repletion at each evaluation time is also reported and descriptively compared. | 16 weeks |
| Percentage of Patients With Peripheral B-cell Counts Depletion at Week 24. | Analysis of the PD parameter peripheral B-Cell count was performed by evaluating the 95% CI for the difference between treatment arms in the percentage of patients with B-cell depletion at 48 hours after dose 1, Week 16, and at Week 24. Percentage of patients with B-cell repletion at each evaluation time is also reported and descriptively compared. | 24 weeks |
| Percentage of Patients With ACR20 at Week 24 | Percentage of the patients with at least 20% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model. | 24 weeks |
| Percentage of Patients With ACR50 at Week 24 | Percentage of the patients with at least 50% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted Response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model. | 24 weeks |
| Percentage of Patients With ACR70 Response at Week 24 | Percentage of the patients with at least 70% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted Response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model. | 24 weeks |
| Change From Baseline in HAQ-DI at Week 24. | The health assessment questionnaire disability index (HAQ-DI) was assessed at Week 24. The disability assessment component of the HAQ, the HAQ-DI, assessed a patient's level of functional ability and included questions about fine movements of the upper extremities, locomotor activities of the lower extremities, and activities that involved both upper and lower extremities. There were 20 questions in 8 categories of functioning which represented a comprehensive set of functional activities-dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asked over the past week "Were you able to" perform a particular task. The patient's responses were made on a scale from 0 (no disability) to 3 (completely disabled). Each category contained at least 2 specific component questions. Physical function was measured using the HAQ-DI Scores, which range from 0-3, with lower scores reflecting better physical function and thus, less disability. | 24 weeks |
| Hyderabad |
| Andhra Pradesh |
| 500034 |
| India |
| Krishna Institute of Medical Sciences Ltd. | Secunderabad | Andhra Pradesh | 500003 | India |
| Yashoda Hospital | Secunderabad | Andhra Predesh | 500003 | India |
| Shalby Hospitals | Ahmedabad | Gujarat | 380015 | India |
| Government Medical College & New Civil Hospital | Surat | Gujarat | 395001 | India |
| Chanre Rheumatology & Immunology Center & Research | Bangalore | Karnataka | 560079 | India |
| Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd | Hubli | Karnataka | 5880021 | India |
| Jagadguru Sri Shivarathreeshwara Hospital | Mysore | Karnataka | 570004 | India |
| Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute | Mumbai | Maharashtra | 400053 | India |
| Jehangir Clinical Development Centre Pvt. Ltd. | Pune | Maharashtra | 411001 | India |
| Deennath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | 411004 | India |
| Oyster & Pearl Hospital | Pune | Maharashtra | 411005 | India |
| lnamdar Multispeciality Hospital | Pune | Maharashtra | 411040 | India |
| Maulana Azad Medical College & Associated Lok Nayak Hospitals | New Delhi | National Capital Territory of Delhi | 110002 | India |
| lndraprastha Apollo Hospitals | New Delhi | National Capital Territory of Delhi | 110076 | India |
| Dayanand Medical College & Hosptial | Ludhiana | Punjab | 141001 | India |
| S. R. Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | 302001 | India |
| Shri Nidaan Hospital & Hope Fertility Centre | Jaipur | Rajasthan | 302006 | India |
| Apollo Specialty Hosptials | Madurai | Tamil Nadu | 625020 | India |
| King George's Medical University | Lucknow | Uttar Pradesh | 226018 | India |
| Communal Healthcare Institution Kharkiv City Clinical Hospital #8 | Kharkiv | 61176 | Ukraine |
| State Institution National Scientific Center Acad. Strazhesko Institute of Cardiology of National Academy of Medical Science | Kyiv | 03680 | Ukraine |
| State Institution D.F. Chebotariov Institute of Gerontology of NAMS of Ukraine | Kyiv | 04114 | Ukraine |
| M.V. Sklifosovskyi Poltava Regional Clinical Hospital | Poltava | 36011 | Ukraine |
| Vinnytsia M.I. Pyrogov Regional Clinical Hospital | Vinnytsia | 21018 | Ukraine |
| Medical Clinical Investigational Center MC LLC Health Clinic | Vinnytsia | 21029 | Ukraine |
| Communal Institution Zaporzhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council | Zaporizhzhia | 69600 | Ukraine |
Rituxan® 500 mg/50 mL solution in a single-use vial. On Day 1, all randomized patients were received one dose of 1000 mg of assigned study drug as a slow IV infusion. The second infusion was administered on Day 15. |
| FG002 | MabThera® (EU Approved Reference Medicinal Product) | MabThera® 500 mg/50 mL solution in a single-use vial. On Day 1, all randomized patients were received one dose of 1000 mg of assigned study drug as a slow IV infusion. The second infusion was administered on Day 15. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Recovery and Follow-up |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DRL- Rituximab-DRL_RI | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
| BG001 | Rituxan® (US Licensed Reference Product): RP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
| BG002 | MabThera® (EU Approved Reference Medicinal Product): RMP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Disease Activity Score-C Reactive Protein (DAS28-CRP) | Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. | All patients who receive at least one dose of study drug and provide at least the baseline (pre-infusion of infusion and one post-baseline assessment of PD endpoints will be included in the PD population. Patients with relevant protocol deviations thought to affect the evaluations of PD endpoints will not be included in the PD population. | Mean | Standard Deviation | Score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-Time Curve From Time 0 to 336 Hours (AUC0-336) Post First Dose | PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose. | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=218 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*h/ml | 2 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Primary | AUC0-∞ Over the Entire Course of Therapy (2 Doses) From Day 1 Through Week 16. | PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose. | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=212 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*h/ml | 16 weeks |
| |||||||||||||||||||||||||||||||||
| Primary | Area Under Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) (Second Dose). | PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=220 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*h/ml | 16 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) After First Dose | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) ,and 168 hours (post-EOI). | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=218. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/ml | 2 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) After Second Dose | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI),6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), and 336 hours post EOI. | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=224 | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/ml | 2 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Cmax (Tmax) After First Dose. | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , and 168 hours (post-EOI). | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=218 | Posted | Median | Full Range | Hours | 2 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Cmax (Tmax) After Second Dose | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , and 168 hours (post-EOI). | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=224 | Posted | Median | Full Range | Hours | 2 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution (Vz) | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion. | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=230 | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 24 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Systemic Clearance (CL) | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion. | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=230 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/day | 24 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Terminal Half-life (t1/2) | Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion. | Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=230 | Posted | Geometric Mean | Geometric Coefficient of Variation | h | 24 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Disease Activity Score-C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Weeks 4 | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 4 weeks minus baseline value). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in DAS28-CRP From Baseline Per Unit Time at 8 Weeks. | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 8 weeks minus baseline value). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in DAS28-CRP From Baseline Per Unit Time at Week 12. | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 12 weeks minus baseline value). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Disease Activity Score- C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Week 16. | In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 16 weeks minus baseline value). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With B-cell Counts 20% Below the Lower Limit of Normal | The time to depletion and repletion of peripheral blood cell counts (determined by CD19+ cell counts) as well as the B-cell counts at selected time points (taking into consideration the patient baseline count) were used to assess the PD of the study drugs. | Posted | Number | Percentage of participants | 48 hours |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Peripheral B-cell Counts Depletion at Week 16. | Analysis of the PD parameter peripheral B-Cell count was performed by evaluating the 95% CI for the difference between treatment arms in the percentage of patients with B-cell depletion at 48 hours after dose 1, Week 16, and at Week 24. Percentage of patients with B-cell repletion at each evaluation time is also reported and descriptively compared. | Posted | Number | percentage of participants | 16 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Peripheral B-cell Counts Depletion at Week 24. | Analysis of the PD parameter peripheral B-Cell count was performed by evaluating the 95% CI for the difference between treatment arms in the percentage of patients with B-cell depletion at 48 hours after dose 1, Week 16, and at Week 24. Percentage of patients with B-cell repletion at each evaluation time is also reported and descriptively compared. | Posted | Number | percentage of participants | 24 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With ACR20 at Week 24 | Percentage of the patients with at least 20% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model. | Posted | Number | Percentage of participants | 24 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With ACR50 at Week 24 | Percentage of the patients with at least 50% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted Response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model. | Posted | Number | Percentage of participants | 24 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With ACR70 Response at Week 24 | Percentage of the patients with at least 70% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted Response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model. | Posted | Number | Percentage of participants | 24 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HAQ-DI at Week 24. | The health assessment questionnaire disability index (HAQ-DI) was assessed at Week 24. The disability assessment component of the HAQ, the HAQ-DI, assessed a patient's level of functional ability and included questions about fine movements of the upper extremities, locomotor activities of the lower extremities, and activities that involved both upper and lower extremities. There were 20 questions in 8 categories of functioning which represented a comprehensive set of functional activities-dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asked over the past week "Were you able to" perform a particular task. The patient's responses were made on a scale from 0 (no disability) to 3 (completely disabled). Each category contained at least 2 specific component questions. Physical function was measured using the HAQ-DI Scores, which range from 0-3, with lower scores reflecting better physical function and thus, less disability. | Posted | Geometric Mean | Standard Deviation | score on a scale | 24 weeks |
|
Baseline up to end of the study (52 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DRL- Rituximab-DRL_RI | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. | 2 | 91 | 3 | 91 | 60 | 91 |
| EG001 | Rituxan® (US Licensed Reference Product): RP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. | 0 | 92 | 5 | 92 | 58 | 92 |
| EG002 | MabThera® (EU Approved Reference Medicinal Product): RMP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. | 0 | 93 | 10 | 93 | 66 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| H1N1 Influenza | Infections and infestations | Systematic Assessment |
| ||
| Penumonia | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Femoral neck fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Forearm fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Febile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Sudden death | General disorders | Systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
| ||
| Spinal cord compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Nasopharyngitis | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Pneumonia | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Acute sinusitis | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Bacteriuria | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Body tinea | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Fungal infection | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Fungal skin infection | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Gastroenteritis | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| H1N1 influenza | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Herpes simplex | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Oral candidiasis | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Pyelonephritis chronic | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Skin infection | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Tonsillitis | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Varicella | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Viral infection | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Vulvovaginitis | Infections and infestations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Nausea | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Gastritis | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Vomiting | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Acid peptic disease | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Aphthous ulcer | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Constipation | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Gingival pain | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Hyperchlorhydia | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Toothache | Gastrointestinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Alanine aminotransferase increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Lymphocyte count decreased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Aspartate aminotransferase increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Hepatic enzyme increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Blood creatnine increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Blood urine present | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| C-reactive protein increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Neutrophil count decreased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Neutrophil count increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Platelet count decreased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Transaminases increased | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| White blood cells urine positive | Investigations | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Trismus | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Wrist deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Pyrexia | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Feeling hot | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Generalized oedema | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Injection site haemorrhage | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Malaise | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Non-cardiac chest pain | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Pain | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Sudden death | General disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Choking sensation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | All AE's are listed as TEAE's for this study |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | All AEs are listed as TEAEs for this study. |
| |
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study. |
| |
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Forearm fracture | Injury, poisoning and procedural complications | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Injury | Injury, poisoning and procedural complications | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Headache | Nervous system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Cervicobrachial syndrome | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Angina pectoris | Cardiac disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Trachycardia | Cardiac disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Ocular hyperaemia | Eye disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Dry eye | Eye disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Eye irritation | Eye disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Hypertension | Vascular disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Thrombophlebitis | Vascular disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Insomnia | Psychiatric disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Anxiety | Psychiatric disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Vertigo | Ear and labyrinth disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Haematuria | Renal and urinary disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
| |
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment | All AEs are listed as TEAEs for this study |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ankit Ranpura, MD (Associate Director- Clinical Development) | Dr. Reddy's Laboratories Ltd, Biologics Survey No. 47, Bachupally Village, Bachupally Mandal, Medchal Malkajgiri District Telangana, India - 500 090 | 040 4464 4000 | ankitr@drreddys.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
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| India |
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|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
|
|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
|
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|
|
|
|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
|
|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
|
|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
|
|
| OG002 | MabThera® (EU Approved Reference Medicinal Product): RMP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
|
| OG002 | MabThera® (EU Approved Reference Medicinal Product): RMP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
|
| OG002 | MabThera® (EU Approved Reference Medicinal Product): RMP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
|
| OG002 | MabThera® (EU Approved Reference Medicinal Product): RMP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
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|
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|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
|
On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
|
| OG002 | MabThera® (EU Approved Reference Medicinal Product): RMP | On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen. |
|
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