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NCT01878123 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
A Phase 1 study of Rheumatoid Arthritis, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT01878123: Completed Phase 1 study of Rheumatoid Arthritis, sponsored by MedImmune.
NCT01878123 is a Phase 1 study of Rheumatoid Arthritis that has completed, run by MedImmune. The registered enrollment target is 26 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01878123, a Phase 1 study of Rheumatoid Arthritis, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.
Primary Outcome
Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL AMP-110
Study Locations (3)
Alabama
- Pinnacle Research Group, LLC - Anniston
Pennsylvania
- Altoona Center for Clinical Research - Duncansville
Texas
- Metroplex Clinical Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01878123 record still lists
NCT01878123 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 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01878123 reports a single indexed study location in Alabama, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT01878123 about?
NCT01878123 is a clinical study titled "Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis". This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.
What is the current status of trial NCT01878123?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-04. Estimated completion is 2014-07.
What conditions does trial NCT01878123 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT01878123?
The interventions under investigation include: Placebo (OTHER), AMP-110 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01878123?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01878123 being conducted?
This trial has 3 study locations across Alabama, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rheumatoid Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01878123's enrollment target sits among peer trials
26 168th of 197 higher than 29 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis 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.
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