Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

Completed · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00838565

Run by

Pfizer

People needed

41

Starts

2009-05-20

Expected to finish

2012-02-02

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Rheumatoid Arthritis on a stable dose of methotrexate
• Rheumatoid Arthritis disease activity as assessed by blood tests

You may not qualify if…

• 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

Where it is running

• Allergy, Asthma, Arthritis, & Lung — Daytona Beach, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Inha University Hospital, Medicine/Rheumatology — Incheon, South Korea
• Seoul National University Hospital, Rheumatology, Internal Medicine — Seoul, South Korea
• Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center — Seoul, South Korea
• Hospital Clinico Universitario de Santiago — Santiago de Compostela, A Coruña, Spain
• Complexo Hospitalario Universitario A Coruña — A Coruña, Spain

Full record on ClinicalTrials.gov

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