A Phase 3 interventional study of Experimental: Arm A: DRL_RI and Arm B: Rituxan®/Mabthera® in Rheumatoid Arthritis, sponsored by Dr. Reddy's Laboratories Limited. Completed at 26 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Dr. Reddy's Laboratories Limited · Phase 3, Interventional, and Treatment
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.
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 primary safety endpoints are:
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 140 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Dr. Reddy's Laboratories Limited is the lead sponsor of 224 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA;
Subjects with the following laboratory abnormalities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: Experimental: Arm A: DRL_RI
Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled. 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.
Biological: Arm B: Rituxan®/Mabthera®
Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
Drug page: Rituximab
Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 1
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: ADA will be obtained at Week 12
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
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
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
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)
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.
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)
Number of TEAEs: Treatment-emergent AE are defined as any AE occurring or worsening on or after the first dose of study medication.
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)
number of subjects reporting AE in the overall study are defined as any AE occurring or worsening after the ICF signed in the study
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)
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.
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)
Safety assessment will be done by measuring 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)
Safety assessment: Number of Subjects Reporting Infusion-related reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3) was reported
Time frame: Assessments of IRRs were carried out at either Week 1 or Week 3
| Milestone | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Started | 70 | 70 |
| Completed | 66 | 68 |
| Not completed | 4 | 2 |
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 1 | 3 | 1 |
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 15 was reported
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects With Positive Anti-Drug Antibodies (ADA) on Day 15 | 1 | 0 |
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 4 was reported
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 4 | 0 | 0 |
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 8 was reported
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 8 | 1 | 0 |
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 12 visits was reported
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects With Positive Anti-Drug Antibodies (ADA) at Week 12 Visits | 1 | 2 |
Number of Subjects reporting anaphylactic reactions during the study drug administration either at Week 1 or Week 3 was reported
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects Reporting Anaphylactic Reactions at Dosing Time Points (Either at Week 1 or Week 3) | 0 | 0 |
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
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects Reporting TEAEs (Treatment Emergent Adverse Events) That Led to Study Drug Discontinuation at Either Week 1 or Week 3 Dosing Timepoint | 1 | 1 |
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.
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects Reporting SAEs (Serious Adverse Events) From Baseline (Week 1) to End of Study (Week 26) | 4 | 2 |
Number of TEAEs: Treatment-emergent AE are defined as any AE occurring or worsening on or after the first dose of study medication.
| Number of events | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of TEAEs Reported From Baseline (Week 1) to End of Study (Week 26) | 35 | 54 |
number of subjects reporting AE in the overall study are defined as any AE occurring or worsening after the ICF signed in the study
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects Reporting AE From Baseline (Week 1) to End of Study (Week 26) | 24 | 27 |
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.
| Participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects Reporting TEAEs From Baseline (Week 1) to End of Study (Week 26) | 24 | 27 |
Safety assessment will be done by measuring hypersensitivity reactions at Dosing Time Points (Either at Week 1 or Week 3)
| participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects Reporting Hypersensitivity Reactions at Dosing Time Points (Either at Week 1 or Week 3) | 0 | 1 |
Safety assessment: Number of Subjects Reporting Infusion-related reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3) was reported
| participants | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| Number of Subjects Reporting Infusion-related Reactions (IRRs) at Dosing Time Points (Either at Week 1 or Week 3) | 2 | 0 |
Collected over Till week 26. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: DRL_RI | 4/70 (5.7%) | 4/70 (5.7%) | 3/70 (4.3%) |
| Arm B: US-Rituximab or EU-Rituximab | 2/70 (2.9%) | 2/70 (2.9%) | 17/70 (24.3%) |
| Event | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| COVID-19 PneumoniaInfections and infestations | 2/70 | 0/70 |
| Myocardial InfarctionCardiac disorders | 1/70 | 0/70 |
| Intestinal resectionSurgical and medical procedures | 1/70 | 0/70 |
| Embolic strokeNervous system disorders | 0/70 | 1/70 |
| EnteritisGastrointestinal disorders | 0/70 | 1/70 |
| CystitisInfections and infestations | 0/70 | 1/70 |
| EmpyemaInfections and infestations | 0/70 | 1/70 |
| Septic ShockInfections and infestations | 0/70 | 1/70 |
| Event | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab |
|---|---|---|
| HeadacheNervous system disorders | 0/70 | 5/70 |
| DiarrhoeaGastrointestinal disorders | 2/70 | 5/70 |
| COVID-19Infections and infestations | 1/70 | 4/70 |
| NasopharyngitisInfections and infestations | 0/70 | 3/70 |
Baseline analysis population include all the randomized study Participants
| Age, Categorical(Participants) | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 47 | 39 | 86 |
| >=65 years | 23 | 31 | 54 |
| Sex: Female, Male(Participants) | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab | Total |
|---|---|---|---|
| Female | 54 | 61 | 115 |
| Male | 16 | 09 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 5 | 12 |
| Not Hispanic or Latino | 60 | 64 | 124 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 69 | 70 | 139 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab | Total |
|---|---|---|---|
| United States | 23 | 22 | 45 |
| Europe | 47 | 48 | 95 |
| Time from prior rituximab(months) | Arm A: DRL_RI | Arm B: US-Rituximab or EU-Rituximab | Total |
|---|---|---|---|
| Mean | 7.5 ± 2.65 | 7.6 ± 2.85 | 7.6 ± 2.77 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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