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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NCT00838565

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Study Location
Allergy, Asthma, Arthritis, & Lung
Daytona Beach, Florida, 32114, United States
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Contact
1-800-718-1021
Cli[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Rheumatoid Arthritis on a stable dose of methotrexate

- Rheumatoid Arthritis disease activity as assessed by blood tests

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
Official Title  ICMJE Phase 1, 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
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.
Detailed Description Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2012)		41
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2009)		40
Actual Study Completion Date  ICMJE February 2, 2012
Actual Primary Completion Date February 2, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838565
Other Study ID Numbers  ICMJE B0151002
2009-009866-15 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2018

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