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NCT01851070 · ClinicalTrials.gov registry record · Phase 2
A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor
A Phase 2 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01851070: Completed Phase 2 study, sponsored by Mesoblast.
NCT01851070 is a Phase 2 study that has completed, run by Mesoblast. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851070, a Phase 2 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary objective of this study is to evaluate the safety, tolerability and feasibility of a single intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who have had an incomplete response to at least one TNF-alpha inhibitor.
Primary Outcome
To evaluate the safety, tolerability and feasibility of a single intravenous (IV) infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other oral DMARDs for at least 4 months and who have had an incomplete response to at least one course of a TNFα inhibitor. Overall safety will be based on the overall assessment of AE/SAEs, Vital Signs, Physica
Interventions
- DRUG Normal Saline
- DRUG Allogeneic Mesenchymal Precursor Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-03 |
| Phase | Phase 2 |
What the finished NCT01851070 record still lists
NCT01851070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT01851070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01851070 about?
NCT01851070 is a clinical study titled "A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor". Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary objective of this study is to evaluate the safety, tolerability and feasibility of a single intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion ...
What is the current status of trial NCT01851070?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2013-07. Estimated completion is 2017-03.
What interventions are being tested in trial NCT01851070?
The interventions under investigation include: Normal Saline (DRUG), Allogeneic Mesenchymal Precursor Cells (DRUG).
Who is sponsoring clinical trial NCT01851070?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01851070's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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