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

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ClinicalTrials.gov Identifier: NCT00838565
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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 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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Placebo Drug: dose level 1 Drug: dose level 2 Drug: dose level 3 Drug: dose level 4 Phase 1

Detailed Description:
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : May 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
intravenous infusion on three consecutive months
Experimental: PF-04236921 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



Primary Outcome Measures :
  1. Safety/Tolerability of Multiple Intravenously Administered Doses of PF-04236921 [ Time Frame: 2 years ]
  2. Pharmacokinetics of PF-04236921 after Multiple Intravenously-Administered Doses [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Pharmacodynamics of PF-04236921 after Multiple Intravenously-Administered Doses [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838565


Locations
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Korea, Republic of
Pfizer Investigational Site
Incheon, Korea, Republic of, 400-711
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15706
Pfizer Investigational Site
A Coruña, Spain, 15006
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838565     History of Changes
Other Study ID Numbers: B0151002
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by Pfizer:
Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases