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Completed

NCT Number: NCT00838565

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 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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inha University Hospital, Medicine/Rheumatology, Incheon, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

intravenous infusion on three consecutive months

Dose level 1

Drug

intravenous infusion on three consecutive months

dose level 2

Drug

intravenous infusion on three consecutive months

Dose level 3

Drug

intravenous infusion on three consecutive months

dose level 4

Drug

intravenous infusion on 3 consecutive months

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)

    An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

  2. Number of Participants With Positive Anti-drug Antibodies Response

    Time frame: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)

  3. Maximum Observed Serum Concentration (Cmax): Day 1

    Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

  4. Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1

    Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

  5. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1

    Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

    AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

  6. Maximum Observed Serum Concentration (Cmax): Day 28

    Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

  7. Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28

    Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose

  8. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28

    Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

    AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

  9. Maximum Observed Serum Concentration (Cmax): Day 56

    Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

  10. Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56

    Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

  11. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56

    Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

    AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

  12. Serum Decay Half-Life (t1/2): Day 56

    Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

    Serum decay half-life is the time measured for the serum concentration to decrease by one half.

Other outcomes

  1. Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation

    Time frame: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra sensitive assay. A decrease in the level of CRP indicates reduction in inflammation.

  2. Change From Baseline in Log CRP Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624

    Time frame: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

  3. Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation

    Time frame: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation

  4. Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624

    Time frame: Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624

    Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 6, 2009
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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