Status:
COMPLETED
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 tolerabilit...
Detailed Description
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.
Eligibility Criteria
Inclusion
- Rheumatoid Arthritis on a stable dose of methotrexate
- Rheumatoid Arthritis disease activity as assessed by blood tests
Exclusion
- 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
Key Trial Info
Start Date :
May 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00838565
Start Date
May 20 2009
End Date
February 2 2012
Last Update
November 2 2018
Active Locations (8)
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1
Allergy, Asthma, Arthritis, & Lung
Daytona Beach, Florida, United States, 32114
2
Millennium Research
Ormond Beach, Florida, United States, 32174
3
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
4
Inha University Hospital, Medicine/Rheumatology
Incheon, South Korea, 400-711