Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/4/2018 |
| Start Date: | May 20, 2009 |
| End Date: | February 2, 2012 |
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
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.
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.
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of
inflammation-related biomarkers.
inflammation-related biomarkers.
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
including but not limited to leflunomide, sulfasalazine, etanercept, infliximab,
adalimumab, abatacept, rituximab
- Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent
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