NCT00838565

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started May 2009

Longer than P75 for phase_1 rheumatoid-arthritis

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2012

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

March 1, 2018

Enrollment Period

2.7 years

First QC Date

February 4, 2009

Results QC Date

August 8, 2017

Last Update Submit

March 12, 2018

Conditions

Rheumatoid Arthritis

Keywords

Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921

Outcome Measures

Primary Outcomes (12)

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

    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.

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

  • Number of Participants With Positive Anti-drug Antibodies Response

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

  • Maximum Observed Serum Concentration (Cmax): Day 1

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

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

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

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

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

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

  • Maximum Observed Serum Concentration (Cmax): Day 28

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

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

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

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

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

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

  • Maximum Observed Serum Concentration (Cmax): Day 56

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

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

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

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

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

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

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

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

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

Other Outcomes (4)

  • 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

    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

  • 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

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

  • 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

    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

  • +1 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

PF-04236921

EXPERIMENTAL
Drug: dose level 1Drug: dose level 2Drug: dose level 3Drug: dose level 4

Interventions

PlaceboDRUG

intravenous infusion on three consecutive months

Placebo
dose level 1DRUG

intravenous infusion on three consecutive months

PF-04236921
dose level 2DRUG

intravenous infusion on three consecutive months

PF-04236921
dose level 3DRUG

intravenous infusion on three consecutive months

PF-04236921
dose level 4DRUG

intravenous infusion on 3 consecutive months

PF-04236921

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid Arthritis on a stable dose of methotrexate
  • Rheumatoid Arthritis disease activity as assessed by blood tests

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Allergy, Asthma, Arthritis, & Lung

Daytona Beach, Florida, 32114, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Inha University Hospital, Medicine/Rheumatology

Incheon, 400-711, South Korea

Location

Seoul National University Hospital, Rheumatology, Internal Medicine

Seoul, 110-744, South Korea

Location

Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center

Seoul, 120-752, South Korea

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29776017DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 6, 2009

Study Start

May 20, 2009

Primary Completion

February 2, 2012

Study Completion

February 2, 2012

Last Updated

November 2, 2018

Results First Posted

November 2, 2018

Record last verified: 2018-03

Locations

ES(2)US(3)KR(3)