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NCT02819726 · ClinicalTrials.gov registry record · Phase 1
PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis
A Phase 1 study, sponsored by Archigen Biotech Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 294
- Enrollment target
NCT02819726: Completed Phase 1 study, sponsored by Archigen Biotech Limited.
NCT02819726 is a Phase 1 study that has completed, run by Archigen Biotech Limited. The registered enrollment target is 294 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (390% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02819726, a Phase 1 study, has completed, sponsored by Archigen Biotech Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 294 participants
- Enrollment target
Study 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.
Primary Outcome
Pharmacokinetic endpoint: Area under the concentration-time curve from time 0 (immediately predose on Day 1) to last quantifiable concentration (AUC0-t). Geometric means by treatment (Pharmacokinetic Analysis Set).
Interventions
- BIOLOGICAL SAIT101
- BIOLOGICAL Rituxan
- BIOLOGICAL MabThera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2016-10-11 |
| Est. Completion | 2018-11-07 |
| Phase | Phase 1 |
What the finished NCT02819726 record still lists
NCT02819726 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (390% higher).
The record links to 0 conditions, and to 3 interventions - of which SAIT101 is the first listed.
NCT02819726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02819726 about?
NCT02819726 is a clinical study titled "PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis". 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.
What is the current status of trial NCT02819726?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 294 participants. The study started on 2016-10-11. Estimated completion is 2018-11-07.
What interventions are being tested in trial NCT02819726?
The interventions under investigation include: SAIT101 (BIOLOGICAL), Rituxan (BIOLOGICAL), MabThera (BIOLOGICAL).
Who is sponsoring clinical trial NCT02819726?
This trial is sponsored by Archigen Biotech Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02819726's enrollment target sits among peer trials
294 135th of 2000 higher than 1,865 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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