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Completed

NCT Number: NCT00446784

Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients with rheumatoid arthritis
  • Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)

Exclusion criteria

  • History of chronic infectious disease such as genitourinary, pulmonary or sinus infections.
  • Any current or known malignancy or history of malignancy within the previous 5 years
  • Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study

Treatment and study plan

CE-224,535

Drug

methotrexate

Drug

Primary outcomes

  1. Incidence and severity of adverse events throughout the study

Secondary outcomes

  1. Pharmacokinetics of CE 224,535 on Days 7 and 8

  2. Pharmacokinetics of Methotrexate on Days 1 and 8

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 13, 2007
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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