Rheumatoid ArthritisPhase 3RI-01-007NCT04268771
A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products
A Phase 3 study testing Experimental: Arm A: DRL_RI and Arm B: Rituxan®/Mabthera® in people with Rheumatoid Arthritis, run by Dr. Reddy's Laboratories Limited at 26 sites in United States.
Trial summary
The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Experimental: Arm A: DRL_RI and Arm B: Rituxan®/Mabthera®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 26 sitesUnited States
- Study dates
- 8 Apr 2020to 20 Apr 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or older who have provided valid written informed consent.
- Subjects with a diagnosis of active RA who are eligible for the subsequent treatment course with US-rituximab or EU-rituximab according to the clinical judgment of the investigator.
- Documented evidence that subject has received at least 1 full course comprising two 1000 mg infusions of either US-rituximab at least 16 weeks prior to the randomization visit or EU-rituximab at least 24 weeks prior to the day of randomization visit.
- Subjects receiving a stable dose of weekly methotrexate (MTX) for at least 4 weeks prior to randomization (between 7.5 mg and 25 mg) and folic acid (at least 5 mg per week.
Who cannot join
- Subjects with RA in functional Class IV
- Subjects with human immunodeficiency virus (positive HIV1Ab or HIV2Ab), hepatitis B virus and/or hepatitis C virus infection, including those with positive results in the viral disease screening.
- Subjects with active tuberculosis. Subjects with evidence of latent TB or a history of TB must have completed treatment or have initiated treatment for at least 1 month before the first dose of study treatment (Day 1). TB testing is required only if it is required by local regulations or practice.
- Active systemic infection.
- Severely immunocompromised.
- History of severe hypersensitivity to either US-rituximab or EU-rituximab or any of its excipients requiring drug discontinuation.
Show all 21Show fewer
- Any serious illness or uncontrolled medical condition, including but not limited to severe infections, significant hepatic or renal disease, uncontrolled hypertension despite treatment (defined as blood pressure ≥160/95 mmHg), congestive heart failure (New York Heart Association [NYHA] Class III or IV), or other severe, uncontrolled cardiac disease or uncontrolled diabetes with immediate risk of acute complications.
- Any condition that in the opinion of the investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.
- Requires treatment with any biological medicinal product during the study other than the study treatment.
- Previous treatment with B-cell modulating or cell depleting biologic therapy except US-rituximab or EU-rituximab.
- Prior participation in this clinical trial or prior participation in any clinical trial with any monoclonal antibody within 12 months of screening or prior participation in any clinical trial within 3 months of screening or within 5 half-lives of the investigational drug or until the expected PD effect has returned to baseline, whichever is longer.
- Treatment with other biologic disease-modifying anti-rheumatic drugs, or Janus kinase (JAK) inhibitors administered within 12 weeks before the first dose of rituximab of the prior treatment course onwards till the date of randomization.
- Subjects with the following laboratory abnormalities:
- Subjects with screening total white blood cell count <3000/μL, platelets <100,000/μL, neutrophils <1,500/μL, or hemoglobin <8.5 g/dL
- Abnormal liver function tests such as aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >2 × upper limit of normal (ULN). A single parameter >2 × ULN can be re-checked as soon as possible, at least prior to randomization, if required as per the investigator's discretion.
- Creatinine clearance (Cockcroft \& Gault formula) of less than 50 mL/min.
- History of vaccination with live vaccines within 4 weeks of the first dose of study treatment (Day 1) or known to require live vaccines during the study.
- Lactating or pregnant female.
- Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g., barrier contraceptives, oral contraceptives, intrauterine devices, true abstinence if it allowed as per the country specific regulatory requirement [periodic abstinence {e.g., calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception], or sterilization) during treatment and for at least 12 months after the last administration of study treatment.
- For men involved in any sexual intercourse that could lead to pregnancy, subjects must agree to use 1 of the highly effective methods of birth control listed in Exclusion Criterion #16 during treatment and for at least 12 months after the last administration of study treatment.
- Subject with serum IgG < lower limit of normal.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
MedBio Trials
Aventura, Florida, 33180
Accurate Clinical Management, LLC
Baytown, Texas, 77521
Trinity Clinical Research LLC, 2008 East Hebron Parkway, Suites 120/114/100,
Carrollton, Texas, 75010
Integrative Rheumatology
Charlotte, North Carolina, 28210
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765
Altoona Center For Clinical Research, 175 Meadowbrook Lane,
Duncansville, Pennsylvania, 16635
Arthritis and Osteoporosis Associates
Freehold, New Jersey, 07728
Abigail Neiman
Houston, Texas, 77084
Accurate Clinical Management, LLC
Houston, Texas, 77084
Laila A Hassan, MD, PA
Houston, Texas, 77084
Accurate Clinical Research-Houston, 11003 Resource Parkway, Suite 102
Houston, Texas, 77089
Houston Rheumatology & Arthritis Specialists
Katy, Texas, 77494
Rheumatology Consultant of Delaware dba Delaware Arthritis
Lewes, Delaware, 19958
Bluegrass Community Research Inc,330 Waller Avenue, Suite 100,
Lexington, Kentucky, 40504.
Medical Research Center
Miami, Florida, 33144
AppleMed Research Group, LLC
Miami, Florida, 33155
California Allergy and Asthma Medical Group - CRN - PPDS 41230 11th Street West, Suite A
Palmdale, California, 93551
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85032
Integral Rheumatology and Immunology Specialist, 140 Southwest 84th Avenue, Suite B
Plantation, Florida, 33324.
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, 78212
Accurate Clinical Research, Inc.
San Antonio, Texas, 78229
Springfield Clinic (Clinic location)
Springfield, Illinois, 62702
Articularis Healthcare Group, Inc dba Low Country Rheumatology
Summerville, South Carolina, 29486
Vicis Clinical Research INC
Tampa, Florida, 33615
Accurate Clinical Research-League City
Texas City, Texas, 77034
Inland Rheumatology Clinical Trials Incorporated
Upland, California, 91786
About this study
Official title: A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®
The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab
To assess the safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
Read the detailed description
This is a randomized, double-blind, parallel group, multicenter, Phase 3 transition study in subjects with active RA who are eligible for the subsequent treatment course with US-rituximab or EU-rituximab according to the clinical judgment of the investigator.
Subjects will then be randomized by interactive web response system (IWRS) to receive either two 1000 mg infusions of DRL_RI (Arm A) or US-rituximab/EU-rituximab (Arm B) on Day 1 and Day 15.
Subjects randomized to Arm A will receive DRL_RI and subjects randomized to Arm B will continue to receive either US-rituximab or EU-rituximab.
The study will consist of a screening period (Days -14 to 0) and a double-blind period (Day 1 to Week 12). Subjects will attend a screening visit followed by a visit at Weeks 0 (Day 1), 2, 4, 8, and 12 after randomization
It is planned that approximately 50 sites will be initiated for this study in up to 7 countries (including but not restricted to United States). There has been no randomization of patients till date for this study.
The study endpoints include:
The immunogenicity endpoint is:
- The incidence of anti-drug antibodies (ADA), including titer and neutralizing antibodies (NAb).
The primary safety endpoints are:
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
- Incidence of anaphylactic reactions, hypersensitivity reactions, and IRRs.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Experimental: Arm A: DRL_RI, Arm B: Rituxan®/Mabthera®
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Arm A: DRL_RIBiological
Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
Arm B: Rituxan®/Mabthera®Biological
Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: DRL_RI | Experimental | Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15 Receives: Biological: Experimental: Arm A: DRL_RI |
| Arm B: US-Rituximab or EU-Rituximab | Active comparator | Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled.
Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab [Rituxan] or EU-approved rituximab [MabThera]) should be the same in the prior and the randomized treatment course, respectively. Receives: Biological: Arm B: Rituxan®/Mabthera® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 1
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
Measured: ADA will be obtained before the administration of study treatment on Day 1
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 15
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 15 was reported
Measured: ADA will be obtained before the administration of study treatment on Day 15
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 4
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 4 was reported
Measured: ADA will be obtained before the administration of study treatment at Week 4
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 8
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 8 was reported
Measured: ADA will be obtained before the administration of study treatment at Week 8
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 12 Visits
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 12 visits was reported
Measured: ADA will be obtained at Week 12
Secondary outcomes (8)
Number of Subjects Reporting Anaphylactic Reactions at Dosing Time Points (Either at Week 1 or Week 3)
Number of Subjects reporting anaphylactic reactions during the study drug administration either at Week 1 or Week 3 was reported
Measured: Assessments of Anaphylactic reactions will be carried out at either Week 1 or Week 3
Number of Subjects Reporting TEAEs (Treatment Emergent Adverse Events) That Led to Study Drug Discontinuation at Either Week 1 or Week 3 Dosing Timepoint
TEAEs (Treatment emergent adverse events) which lead to study subjects discontinuation from the study drug administration at either week 1 or week 3 dosing timepoint
Measured: Assessment of AE's (Adverse Events) that led to study drug discontinuation were carried out at either week 1 or week 3 dosing timepoint
Number of Subjects Reporting SAEs (Serious Adverse Events) From Baseline (Week 1) to End of Study (Week 26)
Incidence of SAEs: SAE is defined as "Results in death, is life-threatening, Requires in-subject hospitalization or prolongs existing hospitalization, Results in persistent or significant disability/incapacity".
The measure here is only subjects reporting SAE.
Measured: Assessment of SAE's was carried out from baseline (week 1) to end of study (week 26)
Number of TEAEs Reported From Baseline (Week 1) to End of Study (Week 26)
Number of TEAEs: Treatment-emergent AE are defined as any AE occurring or worsening on or after the first dose of study medication.
Measured: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)
Number of Subjects Reporting AE From Baseline (Week 1) to End of Study (Week 26)
number of subjects reporting AE in the overall study are defined as any AE occurring or worsening after the ICF signed in the study
Measured: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)
Number of Subjects Reporting TEAEs From Baseline (Week 1) to End of Study (Week 26)
Number of subjects reporting Treatment-emergent AE (TEAEs) are defined as any AE occurring or worsening on or after the first dose of study medication.
Measured: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)
Number of Subjects Reporting Hypersensitivity Reactions at Dosing Time Points (Either at Week 1 or Week 3)
Safety assessment will be done by measuring hypersensitivity reactions at Dosing Time Points (Either at Week 1 or Week 3)
Measured: Assessments of hypersensitivity reactions either at Week 1 or Week 3
Number of Subjects Reporting Infusion-related Reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3)
Safety assessment: Number of Subjects Reporting Infusion-related reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3) was reported
Measured: Assessments of IRRs were carried out at either Week 1 or Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start8 Apr 2020
- Primary completion26 Jan 2022
- Study completion20 Apr 2022
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, parallel group, multicenter study to assess the immunogenicity and safety of transitioning subjects with rheumatoid arthritis to biosimilar rituximab (DRL\_RI) or continued treatment with Rituxan® or MabThera®
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268771
- Sponsor's protocol ID
- RI-01-007
- Acronym
- RI-01-007
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2020
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®
- ClinicalTrials.gov ID
- NCT04268771
- Acronym / sponsor ID
- RI-01-007 / RI-01-007
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab
To assess the safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
Detailed description
This is a randomized, double-blind, parallel group, multicenter, Phase 3 transition study in subjects with active RA who are eligible for the subsequent treatment course with US-rituximab or EU-rituximab according to the clinical judgment of the investigator.
Subjects will then be randomized by interactive web response system (IWRS) to receive either two 1000 mg infusions of DRL_RI (Arm A) or US-rituximab/EU-rituximab (Arm B) on Day 1 and Day 15.
Subjects randomized to Arm A will receive DRL_RI and subjects randomized to Arm B will continue to receive either US-rituximab or EU-rituximab.
The study will consist of a screening period (Days -14 to 0) and a double-blind period (Day 1 to Week 12). Subjects will attend a screening visit followed by a visit at Weeks 0 (Day 1), 2, 4, 8, and 12 after randomization
It is planned that approximately 50 sites will be initiated for this study in up to 7 countries (including but not restricted to United States). There has been no randomization of patients till date for this study.
The study endpoints include:
The immunogenicity endpoint is:
- The incidence of anti-drug antibodies (ADA), including titer and neutralizing antibodies (NAb).
The primary safety endpoints are:
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
- Incidence of anaphylactic reactions, hypersensitivity reactions, and IRRs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, parallel group, multicenter study to assess the immunogenicity and safety of transitioning subjects with rheumatoid arthritis to biosimilar rituximab (DRL_RI) or continued treatment with Rituxan® or MabThera®
| Arm | Type | Receives |
|---|---|---|
| Arm A: DRL_RI | Experimental | Biological: Experimental: Arm A: DRL_RISubjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15 |
| Arm B: US-Rituximab or EU-Rituximab | Active comparator | Biological: Arm B: Rituxan®/Mabthera®Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled. Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab [Rituxan] or EU-approved rituximab [MabThera]) should be the same in the prior and the randomized treatment course, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects aged 18 years or older who have provided valid written informed consent.
- Subjects with a diagnosis of active RA who are eligible for the subsequent treatment course with US-rituximab or EU-rituximab according to the clinical judgment of the investigator.
- Documented evidence that subject has received at least 1 full course comprising two 1000 mg infusions of either US-rituximab at least 16 weeks prior to the randomization visit or EU-rituximab at least 24 weeks prior to the day of randomization visit.
- Subjects receiving a stable dose of weekly methotrexate (MTX) for at least 4 weeks prior to randomization (between 7.5 mg and 25 mg) and folic acid (at least 5 mg per week.
Key exclusion criteria (21 listed)
- Subjects with RA in functional Class IV
- Subjects with human immunodeficiency virus (positive HIV1Ab or HIV2Ab), hepatitis B virus and/or hepatitis C virus infection, including those with positive results in the viral disease screening.
- Subjects with active tuberculosis. Subjects with evidence of latent TB or a history of TB must have completed treatment or have initiated treatment for at least 1 month before the first dose of study treatment (Day 1). TB testing is required only if it is required by local regulations or practice.
- Active systemic infection.
- Severely immunocompromised.
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 |
|---|---|---|
| Experimental: Arm A: DRL_RIProposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion | Biological | Arm A: DRL_RI |
| Arm B: Rituxan®/Mabthera®Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion | Biological | Arm B: US-Rituximab or EU-Rituximab |
Primary outcome
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 1
Time frame: ADA will be obtained before the administration of study treatment on Day 1
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 15
Time frame: ADA will be obtained before the administration of study treatment on Day 15
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 15 was reported
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 4
Time frame: ADA will be obtained before the administration of study treatment at Week 4
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 4 was reported
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 8
Time frame: ADA will be obtained before the administration of study treatment at Week 8
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 8 was reported
Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 12 Visits
Time frame: ADA will be obtained at Week 12
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 12 visits was reported
8 secondary outcomes
Number of Subjects Reporting Anaphylactic Reactions at Dosing Time Points (Either at Week 1 or Week 3)
Time frame: Assessments of Anaphylactic reactions will be carried out at either Week 1 or Week 3
Number of Subjects Reporting TEAEs (Treatment Emergent Adverse Events) That Led to Study Drug Discontinuation at Either Week 1 or Week 3 Dosing Timepoint
Time frame: Assessment of AE's (Adverse Events) that led to study drug discontinuation were carried out at either week 1 or week 3 dosing timepoint
Number of Subjects Reporting SAEs (Serious Adverse Events) From Baseline (Week 1) to End of Study (Week 26)
Time frame: Assessment of SAE's was carried out from baseline (week 1) to end of study (week 26)
Number of TEAEs Reported From Baseline (Week 1) to End of Study (Week 26)
Time frame: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)
Number of Subjects Reporting AE From Baseline (Week 1) to End of Study (Week 26)
Time frame: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)
Number of Subjects Reporting TEAEs From Baseline (Week 1) to End of Study (Week 26)
Time frame: Assessment of AE's will be carried out from baseline (week 1) to end of study (week 26)
Number of Subjects Reporting Hypersensitivity Reactions at Dosing Time Points (Either at Week 1 or Week 3)
Time frame: Assessments of hypersensitivity reactions either at Week 1 or Week 3
Number of Subjects Reporting Infusion-related Reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3)
Time frame: Assessments of IRRs were carried out at either Week 1 or Week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Arm A: DRL_RI and Arm B: Rituxan®/Mabthera® in people with Rheumatoid Arthritis, run by Dr. Reddy's Laboratories Limited at 26 sites in United States.
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 4 inclusion and 21 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Nov 2023). 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?
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 1 (time frame: ADA will be obtained before the administration of study treatment on Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.