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
• Trial end date: 2012-02-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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