NCT00550355

Brief Summary

This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
8 countries

25 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

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 14, 2009

Status Verified

July 1, 2009

Enrollment Period

1.8 years

First QC Date

October 25, 2007

Last Update Submit

July 13, 2009

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (4)

  • Clinical safety laboratories

    16 weeks

  • Vital signs

    16 weeks

  • ECG

    16 weeks

  • Incidence and severity of adverse events

    16 weeks

Secondary Outcomes (2)

  • Pharmacokinetic

    16 weeks

  • Pharmacodynamic

    16 weeks

Study Arms (4)

1

EXPERIMENTAL
Drug: PD 0360324

2

EXPERIMENTAL
Drug: PD 0360324

3

EXPERIMENTAL
Drug: PD 0360324

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PD 0360324DRUG

3 doses of PD 0360324 (Dose level 1) administered over 12 weeks

1
PlaceboDRUG

3 doses of Placebo administered over 12 weeks

4

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of RA for at least 6 months based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. The dose of methotrexate must be stable for at least 6 weeks prior to enrollment.
  • Females of childbearing potential are required to simultaneously use 2 effective contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical cap) with spermicide. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures

You may not qualify if:

  • Diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies); or a non-inflammatory arthritis or musculoskeletal condition (eg, osteoarthritis, fibromyalgia) that, in the investigator's opinion, may interfere with clinical assessments.
  • Evidence of active or latent infection with Mycobacterium tuberculosis (TB).
  • Use of etanercept, anakinra, or oral DMARDs with the exception of methotrexate, within the 4 weeks prior to enrollment. Use of biological DMARDs within the 8 (adalimumab or infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. Use of oral corticosteroids, acetaminophen, NSAIDs, and opioids are permitted within the dose ranges defined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Pfizer Investigational Site

Peoria, Arizona, 85381, United States

Location

Pfizer Investigational Site

Daytona Beach, Florida, 32114, United States

Location

Pfizer Investigational Site

Port Orange, Florida, 32127, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Pfizer Investigational Site

Frederick, Maryland, 21702, United States

Location

Pfizer Investigational Site

Lansing, Michigan, 48910-8595, United States

Location

Pfizer Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Buenos Aires, C1013AAR, Argentina

Location

Pfizer Investigational Site

Pleven, 5800, Bulgaria

Location

Pfizer Investigational Site

Sofia, 1606, Bulgaria

Location

Pfizer Investigational Site

Sofia, 1612, Bulgaria

Location

Pfizer Investigational Site

Brno, 656 91, Czechia

Location

Pfizer Investigational Site

Prague, 140 59, Czechia

Location

Pfizer Investigational Site

México, D.F., 06700, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico City, 14050, Mexico

Location

Pfizer Investigational Site

Bialystok, 15-461, Poland

Location

Pfizer Investigational Site

Bialystok, 15-875, Poland

Location

Pfizer Investigational Site

Krakow, 31-201, Poland

Location

Pfizer Investigational Site

Krakow, 31-752, Poland

Location

Pfizer Investigational Site

Warsaw, 02-637, Poland

Location

Pfizer Investigational Site

Wroclaw, 51-124, Poland

Location

Pfizer Investigational Site

Piešťany, 921 01, Slovakia

Location

Pfizer Investigational Site

Santiago de Compostela, A CORUÑA, 15705, Spain

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 29, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 14, 2009

Record last verified: 2009-07

Locations

US(9)CZ(2)ES(1)AR(1)SL(1)ME(2)BU(3)PL(6)