Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00838565
Previous Study | Return to List | Next Study

Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00838565
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Placebo Drug: dose level 1 Drug: dose level 2 Drug: dose level 3 Drug: dose level 4 Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official 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
Actual Study Start Date : May 20, 2009
Actual Primary Completion Date : February 2, 2012
Actual Study Completion Date : February 2, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838565


Locations
Layout table for location information
United States, Florida
Allergy, Asthma, Arthritis, & Lung
Daytona Beach, Florida, United States, 32114
Millennium Research
Ormond Beach, Florida, United States, 32174
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Korea, Republic of
Inha University Hospital, Medicine/Rheumatology
Incheon, Korea, Republic of, 400-711
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, Korea, Republic of, 110-744
Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center
Seoul, Korea, Republic of, 120-752
Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838565    
Other Study ID Numbers: B0151002
2009-009866-15 ( EudraCT Number )
First Posted: February 6, 2009    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: March 2018
Keywords provided by Pfizer:
Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases