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NCT04268771 · ClinicalTrials.gov registry record · Phase 3
A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products
A Phase 3 study, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
NCT04268771 is a Phase 3 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 140 participants.
The verdict
NCT04268771, a Phase 3 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
Study 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. 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.
Interventions
- BIOLOGICAL Experimental: Arm A: DRL_RI
- BIOLOGICAL Arm B: Rituxan®/Mabthera®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2020-04-08 |
| Est. Completion | 2022-04-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04268771
The ClinicalTrials.gov registry entry for NCT04268771 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Experimental: Arm A: DRL_RI is the first listed.
NCT04268771 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04268771 about?
NCT04268771 is a clinical study titled "A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products". 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 subje...
What is the current status of trial NCT04268771?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2020-04-08. Estimated completion is 2022-04-20.
What interventions are being tested in trial NCT04268771?
The interventions under investigation include: Experimental: Arm A: DRL_RI (BIOLOGICAL), Arm B: Rituxan®/Mabthera® (BIOLOGICAL).
Who is sponsoring clinical trial NCT04268771?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
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