| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00838565 | Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis | PHASE1 | COMPLETED | 41 | — | — | May 20, 2009 | Feb 2, 2012 | Nov 2, 2018 | 8 | United States, South Korea +1 |
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 up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| PF-04236921 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | intravenous infusion on three consecutive months |
| dose level 1 | DRUG | intravenous infusion on three consecutive months |
| dose level 2 | DRUG | intravenous infusion on three consecutive months |
| dose level 3 | DRUG | intravenous infusion on three consecutive months |
| dose level 4 | DRUG | intravenous infusion on 3 consecutive months |
Inclusion Criteria: * Rheumatoid Arthritis on a stable dose of methotrexate * Rheumatoid Arthritis disease activity as assessed by blood tests Exclusion Criteria: * Serious or uncontrolled medical conditions * Current or recent treatment with disease-modifying drugs other than methotrexate includ...