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NCT01999192 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis
A Phase 2 study, sponsored by Biotest.
- Terminated
- Registry status
- Phase 2
- Development phase
- 321
- Enrollment target
NCT01999192: Clinical Trial Phase 2 study, sponsored by Biotest.
NCT01999192 is a Phase 2 study that was terminated before completion, run by Biotest. The registered enrollment target is 321 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999192, a Phase 2 study, was terminated before completion, sponsored by Biotest.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 321 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone. The overall study duration is 24 weeks followed by a 24 week extension phase.
Primary Outcome
The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication. The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.
Interventions
- DRUG Placebo
- DRUG Tregalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
Why NCT01999192 stopped before completion
NCT01999192 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01999192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01999192 about?
NCT01999192 is a clinical study titled "Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis". The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone. The overall study duration is 24 weeks followed by a 24 week exten...
What is the current status of trial NCT01999192?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 321 participants. The study started on 2013-10. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01999192?
The interventions under investigation include: Placebo (DRUG), Tregalizumab (DRUG).
Who is sponsoring clinical trial NCT01999192?
This trial is sponsored by Biotest, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01999192's enrollment target sits among peer trials
321 151st of 2000 higher than 1,849 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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