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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628095
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : October 12, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: CE-224,535 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Drug: CE-224,535
500 mg po BID

Placebo Comparator: Placebo Drug: Placebo
no active ingredient

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00628095

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00628095     History of Changes
Other Study ID Numbers: A6341009
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
rheumatoid arthritis DMARD methotrexate

Additional relevant MeSH terms:
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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