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NCT01261403 · ClinicalTrials.gov registry record · Phase 2
Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis
A Phase 2 study, sponsored by Celularity Incorporated.
- Terminated
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01261403: Clinical Trial Phase 2 study, sponsored by Celularity Incorporated.
NCT01261403 is a Phase 2 study that was terminated before completion, run by Celularity Incorporated. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261403, a Phase 2 study, was terminated before completion, sponsored by Celularity Incorporated.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the safety and efficacy of 2 dose groups (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary objectives of the study are to determine the clinical response at defined visit intervals, determine the time to flare of RA symptoms and to quantify changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6.
Primary Outcome
A participant is a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]) o Patient's global assessment of disease activity (measured on a 100 mm VAS) o Physician's global assessment of disease activity (measured on a 100 mm VAS) o P
Interventions
- BIOLOGICAL PDA001
- DRUG Vehicle Controlled Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
Why NCT01261403 stopped before completion
NCT01261403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which PDA001 is the first listed.
NCT01261403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01261403 about?
NCT01261403 is a clinical study titled "Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis". The primary objective of the study is to assess the safety and efficacy of 2 dose groups (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary objectives of the study are to determine the clinical response at defined visit intervals, determine the time to flare ...
What is the current status of trial NCT01261403?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-12. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01261403?
The interventions under investigation include: PDA001 (BIOLOGICAL), Vehicle Controlled Placebo (DRUG).
Who is sponsoring clinical trial NCT01261403?
This trial is sponsored by Celularity Incorporated, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01261403's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 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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