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NCT00838565 · ClinicalTrials.gov registry record · Phase 1
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT00838565: Completed Phase 1 study, sponsored by Pfizer.
NCT00838565 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00838565, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and u
Interventions
- DRUG Placebo
- DRUG dose level 1
- DRUG dose level 2
- DRUG dose level 3
- DRUG dose level 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-05-20 |
| Est. Completion | 2012-02-02 |
| Phase | Phase 1 |
What the finished NCT00838565 record still lists
NCT00838565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00838565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00838565 about?
NCT00838565 is a clinical study titled "Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis". This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood t...
What is the current status of trial NCT00838565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2009-05-20. Estimated completion is 2012-02-02.
What interventions are being tested in trial NCT00838565?
The interventions under investigation include: Placebo (DRUG), dose level 1 (DRUG), dose level 2 (DRUG), dose level 3 (DRUG), dose level 4 (DRUG).
Who is sponsoring clinical trial NCT00838565?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00838565's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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