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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.
 
ClinicalTrials.gov Identifier: NCT00628095
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : October 12, 2009
Sponsor:
Information provided by:
Pfizer

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

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, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT00628095


Locations
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United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85202
United States, Florida
Pfizer Investigational Site
Debary, Florida, United States, 32713
Pfizer Investigational Site
Lake Mary, Florida, United States, 32746
Pfizer Investigational Site
Tampa, Florida, United States, 33614
United States, Indiana
Pfizer Investigational Site
Avon, Indiana, United States, 46123
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Maryland
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
United States, Missouri
Pfizer Investigational Site
Columbia, Missouri, United States, 65203
Pfizer Investigational Site
Columbia, Missouri, United States, 65212
United States, Nevada
Pfizer Investigational Site
Reno, Nevada, United States, 89502
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99204-2336
Chile
Pfizer Investigational Site
Providencia, Santiago, RM, Chile, 7530206
Czech Republic
Pfizer Investigational Site
Ceska Lipa, Czech Republic, 470 01
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Pfizer Investigational Site
Praha 4, Czech Republic, 140 00
Korea, Republic of
Pfizer Investigational Site
Incheon, Korea, Republic of, 400-711
Pfizer Investigational Site
Pusan, Korea, Republic of, 602-739
Mexico
Pfizer Investigational Site
Mexico, D.f., Mexico, 03300
Poland
Pfizer Investigational Site
Krakow, Poland, 31-501
Pfizer Investigational Site
Poznan, Poland, 60-356
Pfizer Investigational Site
Poznan, Poland, 61-545
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15705
Pfizer Investigational Site
A Coruña, Spain, 15006
Pfizer Investigational Site
Madrid, Spain, 28007
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00628095    
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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases