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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

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
History of Changes

February 4, 2009
March 28, 2012
May 2009
February 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00838565 on ClinicalTrials.gov Archive Site
Pharmacodynamics of PF-04236921 after Multiple Intravenously-Administered Doses [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
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

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.

Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Rheumatoid Arthritis
  • Drug: Placebo
    intravenous infusion on three consecutive months
  • 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
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-04236921
    Interventions:
    • Drug: dose level 1
    • Drug: dose level 2
    • Drug: dose level 3
    • Drug: dose level 4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Korea, Republic of,   Spain
 
NCT00838565
B0151002
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP