Rheumatoid ArthritisPhase 1/2NCT02296775
Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis
A Phase 1/2 study testing DRL_RI, Rituxan and MabThera in people with Rheumatoid Arthritis, run by Dr. Reddy's Laboratories Limited at 28 sites in 2 countries.
Trial summary
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®). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- DRL_RI, Rituxan and MabThera
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Nov 2014to 5 Oct 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 18 to 65 years of age
- Diagnosis of RA, according to ACR criteria (1987), of at least 6 months duration
- At randomization, tender joint count ≥ 6 and swollen joint count ≥ 6
- Evidence of at least moderate disease activity
- Patients receiving oral or parenteral MTX with a dose of 15 to 25 mg per week when given alone or 10 to 25 mg per week in combination with additional non-biologic DMARD(s) for at least 6 months and on stable dose for at least 3 months
- Patients must be on a stable dose of folic acid or equivalent (≥5 mg per week)
- Chest X-ray not suggestive of any lung infections including pulmonary tuberculosis (TB)
- Contraception required per protocol
Who cannot join
- Prior therapy with
- Rituximab, abatacept, tocilizumab, anakinra or an agent/antibody targeting CD20, CD19 or B cells
- Tumor necrosis factor (TNF) alfa antagonists or other biologic DMARDs
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
India21 sites
Shalby Hospitals
Ahmedabad, Gujarat, 380015
Chanre Rheumatology & Immunology Center & Research
Bangalore, Karnataka, 560079
Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd
Hubli, Karnataka, 5880021
Gurunank Care Hospital
Hyderabad, Andhra Pradesh, 500020
Care Hospitals
Hyderabad, Andhra Pradesh, 500034
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
Shri Nidaan Hospital & Hope Fertility Centre
Jaipur, Rajasthan, 302006
King George's Medical University
Lucknow, Uttar Pradesh, 226018
Dayanand Medical College & Hosptial
Ludhiana, Punjab, 141001
Apollo Specialty Hosptials
Madurai, Tamil Nadu, 625020
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Mumbai, Maharashtra, 400053
Jagadguru Sri Shivarathreeshwara Hospital
Mysore, Karnataka, 570004
Maulana Azad Medical College & Associated Lok Nayak Hospitals
New Delhi, National Capital Territory of Delhi, 110002
lndraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, 411001
Deennath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Oyster & Pearl Hospital
Pune, Maharashtra, 411005
lnamdar Multispeciality Hospital
Pune, Maharashtra, 411040
Krishna Institute of Medical Sciences Ltd.
Secunderabad, Andhra Pradesh, 500003
Yashoda Hospital
Secunderabad, Andhra Predesh, 500003
Government Medical College & New Civil Hospital
Surat, Gujarat, 395001
Ukraine7 sites
Communal Healthcare Institution Kharkiv City Clinical Hospital #8
Kharkiv, 61176
State Institution National Scientific Center Acad. Strazhesko Institute of Cardiology of National Academy of Medical Science
Kyiv, 03680
State Institution D.F. Chebotariov Institute of Gerontology of NAMS of Ukraine
Kyiv, 04114
M.V. Sklifosovskyi Poltava Regional Clinical Hospital
Poltava, 36011
Vinnytsia M.I. Pyrogov Regional Clinical Hospital
Vinnytsia, 21018
Medical Clinical Investigational Center MC LLC Health Clinic
Vinnytsia, 21029
Communal Institution Zaporzhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhya, 69600
About this study
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
- Conditions
- Rheumatoid Arthritis
- Being tested
- DRL_RI, Rituxan, MabThera
- Keywords
- Rheumatoid arthritis, Rituximab, Pharmacokinetics
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRL_RIBiological
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
RituxanBiological
Also called Rituximab
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
MabTheraBiological
Also called Rituximab
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
| Study group | Role | What they receive |
|---|---|---|
| DRL_RI | Experimental | Not described Receives: Biological: DRL_RI |
| Rituxan | Active comparator | Not described Receives: Biological: Rituxan |
| MabThera | Active comparator | Not described Receives: Biological: MabThera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 16 weeks
Secondary outcomes (18)
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).
Measured: 2 weeks
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296775
- Sponsor's protocol ID
- RI-01-003
- Status last verified
- Dec 2019
- First submitted
- 18 Nov 2014
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32052313
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02296775
- Acronym / sponsor ID
- RI-01-003
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Rituximab, Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DRL_RI | Experimental | Biological: DRL_RI |
| Rituxan | Active comparator | Biological: Rituxan |
| MabThera | Active comparator | Biological: MabThera |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients, 18 to 65 years of age
- Diagnosis of RA, according to ACR criteria (1987), of at least 6 months duration
- At randomization, tender joint count ≥ 6 and swollen joint count ≥ 6
- Evidence of at least moderate disease activity
- Patients receiving oral or parenteral MTX with a dose of 15 to 25 mg per week when given alone or 10 to 25 mg per week in combination with additional non-biologic DMARD(s) for at least 6 months and on stable dose for at least 3 months
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRL_RITwo 1000 mg intravenous infusions, one each on Day 1 and Day 15 | Biological | DRL_RI |
| RituxanAlso: RituximabTwo 1000 mg intravenous infusions, one each on Day 1 and Day 15 | Biological | Rituxan |
| MabTheraAlso: RituximabTwo 1000 mg intravenous infusions, one each on Day 1 and Day 15 | Biological | MabThera |
Primary outcome
Area Under the Concentration-Time Curve From Time 0 to 336 Hours (AUC0-336) Post First Dose
Time frame: 2 weeks
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.
AUC0-∞ Over the Entire Course of Therapy (2 Doses) From Day 1 Through Week 16.
Time frame: 16 weeks
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.
Area Under Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) (Second Dose).
Time frame: 16 weeks
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
18 secondary outcomes
Maximum Plasma Concentration (Cmax) After First Dose
Time frame: 2 weeks
Maximum Plasma Concentration (Cmax) After Second Dose
Time frame: 2 weeks
Time to Cmax (Tmax) After First Dose.
Time frame: 2 weeks
Time to Cmax (Tmax) After Second Dose
Time frame: 2 weeks
Volume of Distribution (Vz)
Time frame: 24 weeks
Systemic Clearance (CL)
Time frame: 24 weeks
Terminal Half-life (t1/2)
Time frame: 24 weeks
Mean Change in Disease Activity Score-C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Weeks 4
Time frame: Baseline and 4 weeks
Mean Change in DAS28-CRP From Baseline Per Unit Time at 8 Weeks.
Time frame: Baseline and 8 weeks
Mean Change in DAS28-CRP From Baseline Per Unit Time at Week 12.
Time frame: Baseline and 12 weeks
Mean Change in Disease Activity Score- C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Week 16.
Time frame: Baseline and 16 weeks
Percentage of Patients With B-cell Counts 20% Below the Lower Limit of Normal
Time frame: 48 hours
Percentage of Patients With Peripheral B-cell Counts Depletion at Week 16.
Time frame: 16 weeks
Percentage of Patients With Peripheral B-cell Counts Depletion at Week 24.
Time frame: 24 weeks
Percentage of Patients With ACR20 at Week 24
Time frame: 24 weeks
Percentage of Patients With ACR50 at Week 24
Time frame: 24 weeks
Percentage of Patients With ACR70 Response at Week 24
Time frame: 24 weeks
Change From Baseline in HAQ-DI at Week 24.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32052313Haridas 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.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DRL_RI, Rituxan and MabThera in people with Rheumatoid Arthritis, run by Dr. Reddy's Laboratories Limited at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in India, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve From Time 0 to 336 Hours (AUC0-336) Post First Dose (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.