Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00628095

Purpose

CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: CE-224,535 Drug: Placebo	Phase II Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CE-224,535, An Antagonist Of The P2x7 Receptor, In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate

Further study details as provided by Pfizer:

Primary Outcome Measures:

ACR 20 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DAS 28(3) crp [ Time Frame: 2,4,8, and 12 weeks ] [ Designated as safety issue: No ]
pharmacokinetics [ Time Frame: 2,4 weeks ] [ Designated as safety issue: No ]
adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
ACR 50 and 70 [ Time Frame: 2,4,8, and 12 weeks ] [ Designated as safety issue: No ]
components of ACR responses [ Time Frame: 2,4,8, and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	Drug: CE-224,535 500 mg po BID
Placebo: Placebo Comparator	Drug: Placebo no active ingredient

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active rheumatoid arthritis
Incomplete response to methotrexate

Exclusion Criteria:

Must not be on biologic therapies
No recent infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628095

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 25 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6341009
Study First Received:	February 25, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00628095
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

rheumatoid arthritis DMARD methotrexate

Study placed in the following topic categories:

Folic Acid
Signs and Symptoms
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009