Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550355
• Other study ID #: A6261002
• Status: Completed
• Phase: Phase 1
• First received: October 25, 2007
• Last updated: July 13, 2009
• Start date: August 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

• Contact your local site for more inclusion criteria.

Exclusion Criteria:

• 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 your local site for more inclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
• PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
• PD 0360324
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
• Placebo
3 doses of Placebo administered over 12 weeks

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Bulgaria	Pfizer Investigational Site	Pleven
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Praha 4
Mexico	Pfizer Investigational Site	Mexico	D.f.
Mexico	Pfizer Investigational Site	Mexico	DF
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wroclaw
Slovakia	Pfizer Investigational Site	Piestany
Spain	Pfizer Investigational Site	Santiago de Compostela	A Coruña
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Frederick	Maryland
United States	Pfizer Investigational Site	Lansing	Michigan
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Peoria	Arizona
United States	Pfizer Investigational Site	Port Orange	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Czech Republic,  Mexico,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical safety laboratories		16 weeks	Yes
Primary	Vital signs		16 weeks	Yes
Primary	ECG		16 weeks	Yes
Primary	Incidence and severity of adverse events		16 weeks	Yes
Secondary	Pharmacokinetic		16 weeks	No
Secondary	Pharmacodynamic		16 weeks	No

External Links

•   To obtain contact information for a study center near you, click here.