Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
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
2 other identifiers
interventional
100
7 countries
27
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 4, 2008
CompletedStudy Start
First participant enrolled
April 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2009
CompletedResults Posted
Study results publicly available
April 4, 2022
CompletedApril 4, 2022
March 1, 2022
10 months
February 25, 2008
January 26, 2022
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Week 12
Secondary Outcomes (12)
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
Week 2, 4, 8
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 2, 4, 8, 12
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 2, 4, 8, 12
Number of Tender/Painful and Swollen Joints
Baseline, Week 2, 4, 8, 12
Physician Global Assessment (PGA) of Arthritis
Baseline, Week 2, 4, 8, 12
- +7 more secondary outcomes
Other Outcomes (1)
CE-224,535 Plasma Concentrations
0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4
Study Arms (2)
Active
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Active rheumatoid arthritis
- Incomplete response to methotrexate
You may not qualify if:
- Must not be on biologic therapies
- No recent infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Arizona Arthritis & Rheumatology Associates, P.C.
Mesa, Arizona, 85202, United States
Omega Research Consultants LLC
DeBary, Florida, 32713, United States
Florida Arthritis Center
Lake Mary, Florida, 32746, United States
Tampa Medical Group, PA
Tampa, Florida, 33614, United States
American Health Network
Avon, Indiana, 46123, United States
Best Clinical Trials, LLC (Administrative Only)
New Orleans, Louisiana, 70115, United States
George Stanley Walker, MD
New Orleans, Louisiana, 70115, United States
Majid Abdul Jawad, MD
New Orleans, Louisiana, 70115, United States
The Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, 21702, United States
University Physicians
Columbia, Missouri, 65203, United States
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Arthritis Northwest
Spokane, Washington, 99204-2336, United States
Clínica Santa María, Sección Reumatología
Providencia, Santiago, RM, 7530206, Chile
Revmatologicka ambulance
Česká Lípa, 470 01, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
Revmatologicka ambulance
Prague, 140 00, Czechia
Investigadores Clinicos Asociados
México, D.F., 03300, Mexico
Krakowskie Centrum Medyczne NZOZ
Krakow, 31-501, Poland
Zaklad Reumatologii i Immunologii Klinicznej
Poznan, 60-356, Poland
Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny
Poznan, 61-545, Poland
Inha University Hospital, Medicine/Rheumatology
Incheon, 400-711, South Korea
Pusan National University Hospital, Rheumatology, Internal Medicine
Pusan, 602-739, South Korea
Hospital Nuestra Señora de La Esperanza
Santiago de Compostela, A Coruña, 15705, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Related Publications (1)
Stock TC, Bloom BJ, Wei N, Ishaq S, Park W, Wang X, Gupta P, Mebus CA. Efficacy and safety of CE-224,535, an antagonist of P2X7 receptor, in treatment of patients with rheumatoid arthritis inadequately controlled by methotrexate. J Rheumatol. 2012 Apr;39(4):720-7. doi: 10.3899/jrheum.110874. Epub 2012 Mar 1.
PMID: 22382341DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 4, 2008
Study Start
April 7, 2008
Primary Completion
February 4, 2009
Study Completion
February 4, 2009
Last Updated
April 4, 2022
Results First Posted
April 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.