Trials / Completed
CompletedNCT02819726
PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis
A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (RA)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 294 (actual)
- Sponsor
- Archigen Biotech Limited · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A randomised, double blind, parallel group, multicentre study yo compare the pharmacokinetics, pharmacokinetics, safety and efficacy of SAIT101 versus MabThera® versus Rituxan® in patients with rheumatoid arthritis.
Detailed description
This is a randomized, double-blind, parallel group, multicenter study to compare the pharmacokinetics (PK), pharmacodynamics (PD), safety, efficacy, tolerability, and immunogenicity of SAIT101 (biosimilar rituximab) versus MabThera® versus Rituxan® in patients with rheumatoid arthritis (RA). This study will take place globally across approximately 75 study centers in order to randomize approximately 282 patients. The study consists of Part A from baseline for PK and efficacy analysis, followed by Part B from Week 24 to 52 for safety follow-up in which collects transition data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SAIT101 | 1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible patients. |
| BIOLOGICAL | MabThera | 1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible patients. |
| BIOLOGICAL | Rituxan | 1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible patients. |
Timeline
- Start date
- 2016-10-11
- Primary completion
- 2018-04-30
- Completion
- 2018-11-07
- First posted
- 2016-06-30
- Last updated
- 2020-02-17
- Results posted
- 2020-02-17
Locations
75 sites across 11 countries: United States, Bosnia and Herzegovina, Bulgaria, Czechia, Germany, Hungary, India, Mexico, Poland, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02819726. Inclusion in this directory is not an endorsement.