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NCT03976102 · ClinicalTrials.gov registry record · Phase 3
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
A Phase 3 study, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 317
- Enrollment target
NCT03976102 is a Phase 3 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 317 participants.
The verdict
NCT03976102, a Phase 3 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 317 participants
- Enrollment target
Study Summary
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL). Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity. The study will compare the safety and efficacy of DRL\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
Interventions
- BIOLOGICAL DRL_RI (Proposed rituximab biosimilar)
- OTHER MabThera®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2023-02-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03976102
The ClinicalTrials.gov registry entry for NCT03976102 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 317 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 DRL_RI (Proposed rituximab biosimilar) is the first listed.
NCT03976102 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03976102 about?
NCT03976102 is a clinical study titled "Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma". The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL). Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) ...
What is the current status of trial NCT03976102?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 317 participants. The study started on 2019-05-15. Estimated completion is 2023-02-27.
What interventions are being tested in trial NCT03976102?
The interventions under investigation include: DRL_RI (Proposed rituximab biosimilar) (BIOLOGICAL), MabThera® (OTHER).
Who is sponsoring clinical trial NCT03976102?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
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