Study Of The Safety Of CE 224,545 And Methotrexate In Pat... | NCT00446784

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

NCT00446784

Sponsor

Pfizer

Status

Completed

Last Update Posted

May 23, 2011Estimated

Enrollment

Phase

Phase 1

Conditions

Arthritis, Rheumatoid

Interventions

CE-224,535
Methotrexate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Mar 9, 2007

First Submission Date that Met QC Criteria

Mar 9, 2007

First Posted Date

Mar 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2011

Last Update Posted Date

May 23, 2011Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of adverse events throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of CE 224,535 on Days 7 and 8
Pharmacokinetics of Methotrexate on Days 1 and 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Miami	Florida	33169	United States
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring

Name	Type	Description	Arm Group Labels	Other Names
CE-224,535	Drug
Methotrexate	Drug