A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products
Public ClinicalTrials.gov record NCT04268771. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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®
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04268771
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Interventions
- Experimental: Arm A: DRL_RI Biological
- Arm B: Rituxan®/Mabthera® Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 8, 2020 (Actual)
- Primary completion
- Jan 26, 2022 (Actual)
- Completion
- Apr 20, 2022 (Actual)
- Last update posted
- Nov 18, 2023
2020 – 2022
United States locations
- U.S. sites
- 26
- U.S. states
- 11
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85032 | — |
| California Allergy and Asthma Medical Group - CRN - PPDS 41230 11th Street West, Suite A | Palmdale | California | 93551 | — |
| Inland Rheumatology Clinical Trials Incorporated | Upland | California | 91786 | — |
| Rheumatology Consultant of Delaware dba Delaware Arthritis | Lewes | Delaware | 19958 | — |
| MedBio Trials | Aventura | Florida | 33180 | — |
| Clinical Research of West Florida Inc - Clearwater | Clearwater | Florida | 33765 | — |
| Medical Research Center | Miami | Florida | 33144 | — |
| AppleMed Research Group, LLC | Miami | Florida | 33155 | — |
| Integral Rheumatology and Immunology Specialist, 140 Southwest 84th Avenue, Suite B | Plantation | Florida | 33324. | — |
| Vicis Clinical Research INC | Tampa | Florida | 33615 | — |
| Springfield Clinic (Clinic location) | Springfield | Illinois | 62702 | — |
| Bluegrass Community Research Inc,330 Waller Avenue, Suite 100, | Lexington | Kentucky | 40504. | — |
| Arthritis and Osteoporosis Associates | Freehold | New Jersey | 07728 | — |
| Integrative Rheumatology | Charlotte | North Carolina | 28210 | — |
| Altoona Center For Clinical Research, 175 Meadowbrook Lane, | Duncansville | Pennsylvania | 16635 | — |
| Articularis Healthcare Group, Inc dba Low Country Rheumatology | Summerville | South Carolina | 29486 | — |
| Accurate Clinical Management, LLC | Baytown | Texas | 77521 | — |
| Trinity Clinical Research LLC, 2008 East Hebron Parkway, Suites 120/114/100, | Carrollton | Texas | 75010 | — |
| 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 | — |
| Clinical Associates in Research Therapeutics of America, LLC | San Antonio | Texas | 78212 | — |
| Accurate Clinical Research, Inc. | San Antonio | Texas | 78229 | — |
| Accurate Clinical Research-League City | Texas City | Texas | 77034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04268771, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 18, 2023 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04268771 live on ClinicalTrials.gov.