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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00446784
• Collaborator: (none)
• Enrollment: 20
• Locations: 5
• Duration (Months): 4
• Patients Per Site: 4
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: CE-224,535; Drug: Methotrexate	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of adverse events throughout the study []

Secondary Outcome Measures

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

2. Pharmacokinetics of Methotrexate on Days 1 and 8 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Miami	Florida	United States	33169
2	Pfizer Investigational Site	Ocala	Florida	United States	34471
3	Pfizer Investigational Site	Ocala	Florida	United States	34474
4	Pfizer Investigational Site	Kalamazoo	Michigan	United States	49007
5	Pfizer Investigational Site	Ducansville	Pennsylvania	United States	16635

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00446784
• Other Study ID Numbers: A6341006
• First Posted: Mar 13, 2007
• Last Update Posted: May 23, 2011
• Last Verified: May 1, 2011

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Methotrexate

Study Results

No Results Posted as of May 23, 2011