NCT04268771

A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

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®

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 incidence of anti-drug antibodies (ADA), including titer and neutralizing antibodies (NAb). The primary safety endpoints are: * Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). * Incidence of anaphylactic reactions, hypersensitivity reactions, and IRRs.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Experimental: Arm A: DRL_RI	Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
BIOLOGICAL	Arm B: Rituxan®/Mabthera®	Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion

Timeline

• Start date: 2020-04-08
• Primary completion: 2022-01-26
• Completion: 2022-04-20
• First posted: 2020-02-13
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study