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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00838565
First received: February 4, 2009
Last updated: March 28, 2012
Last verified: March 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ]

Enrollment: 41
Study Start Date: May 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
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
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838565     History of Changes
Other Study ID Numbers: B0151002
Study First Received: February 4, 2009
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014