Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PF-04236921 in Patients With Rheumatoid Arthritis

This study is not yet open for participant recruitment.

Verified by Pfizer, May 2009

First Received: February 4, 2009 Last Updated: May 1, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00838565

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Placebo Drug: dose level 1 Drug: dose level 2 Drug: dose level 3 Drug: dose level 4	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title:	Phase I, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety/Tolerability of Multiple Intravenously Administered Doses of PF-04236921 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Pharmacokinetics of PF-04236921 after Multiple Intravenously-Administered Doses [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamics of PF-04236921 after Multiple Intravenously-Administered Doses [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo intravenous infusion on three consecutive months
PF-04236921: Experimental	Drug: dose level 1 intravenous infusion on three consecutive months Drug: dose level 2 intravenous infusion on three consecutive months Drug: dose level 3 intravenous infusion on three consecutive months Drug: dose level 4 intravenous infusion on 3 consecutive months

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838565

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0151002
Study First Received:	February 4, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00838565 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 06, 2009