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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: Completed Phase 3 study, sponsored by Dr. Reddy's Laboratories Limited.
NCT04268771 is a Phase 3 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 140 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
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 |
What the finished NCT04268771 record still lists
NCT04268771 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Experimental: Arm A: DRL_RI is the first listed.
NCT04268771 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04268771's enrollment target sits among peer trials
140 1565th of 2000 higher than 424 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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