- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00838565
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
March 12, 2018 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Incheon, Korea, Republic of, 400-711
- Inha University Hospital, Medicine/Rheumatology
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital, Rheumatology, Internal Medicine
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Seoul, Korea, Republic of, 120-752
- Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center
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A Coruña, Spain, 15006
- Complexo Hospitalario Universitario A Coruña
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A Coruña
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Santiago de Compostela, A Coruña, Spain, 15706
- Hospital Clínico Universitario de Santiago
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Florida
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Daytona Beach, Florida, United States, 32114
- Allergy, Asthma, Arthritis, & Lung
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Ormond Beach, Florida, United States, 32174
- Millennium Research
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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intravenous infusion on three consecutive months
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Experimental: PF-04236921
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intravenous infusion on three consecutive months
intravenous infusion on three consecutive months
intravenous infusion on three consecutive months
intravenous infusion on 3 consecutive months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
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Number of Participants With Positive Anti-drug Antibodies Response
Time Frame: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
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Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
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Maximum Observed Serum Concentration (Cmax): Day 1
Time Frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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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
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Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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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
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AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
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Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
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Maximum Observed Serum Concentration (Cmax): Day 28
Time Frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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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
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Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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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
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AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
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Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
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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
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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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
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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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
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AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
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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
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Serum decay half-life is the time measured for the serum concentration to decrease by one half.
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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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
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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
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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.
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Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
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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
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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
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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
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Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method.
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Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2009
Primary Completion (Actual)
February 2, 2012
Study Completion (Actual)
February 2, 2012
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 6, 2009
Study Record Updates
Last Update Posted (Actual)
November 2, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B0151002
- 2009-009866-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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