CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 41 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00838565
NCT00838565Phase 1Completed

Phase 1, Randomized, Patient And Investigator-blind, Placebo-controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of Pf-04236921 In Patients With Rheumatoid Arthritis Receiving Methotrexate

Pfizer·interventional·Posted Feb 6, 2009·Updated Nov 2, 2018

In Brief

A Phase 1 clinical trial evaluating Placebo, dose level 1, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 41 participants across 8 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea, Spain, United States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2009
Enrollment StartMay 20, 2009
Primary CompletionFeb 2, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.4 years ago

Interventions

Placebodrug

intravenous infusion on three consecutive months

dose level 1drug

intravenous infusion on three consecutive months

dose level 2drug

intravenous infusion on three consecutive months

dose level 3drug

intravenous infusion on three consecutive months

dose level 4drug

intravenous infusion on 3 consecutive months