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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: February 25, 2008
Last updated: October 7, 2009
Last verified: October 2009
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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • ACR 20 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • DAS 28(3) crp [ Time Frame: 2,4,8, and 12 weeks ]
  • pharmacokinetics [ Time Frame: 2,4 weeks ]
  • adverse events [ Time Frame: 12 weeks ]
  • ACR 50 and 70 [ Time Frame: 2,4,8, and 12 weeks ]
  • components of ACR responses [ Time Frame: 2,4,8, and 12 weeks ]

Enrollment: 100
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: CE-224,535
500 mg po BID
Placebo Comparator: Placebo Drug: Placebo
no active ingredient


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Active rheumatoid arthritis
  • Incomplete response to methotrexate

Exclusion Criteria:

  • Must not be on biologic therapies
  • No recent infections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00628095

  Show 25 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00628095     History of Changes
Other Study ID Numbers: A6341009
Study First Received: February 25, 2008
Last Updated: October 7, 2009

Keywords provided by Pfizer:
rheumatoid arthritis DMARD methotrexate

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on September 20, 2017