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

NCT ID: NCT00628095

Last Updated: 2022-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-07

Study Completion Date

2009-02-04

Brief Summary

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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

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Group Type EXPERIMENTAL

CE-224,535

Intervention Type DRUG

500 mg po BID

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

no active ingredient

Interventions

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CE-224,535

500 mg po BID

Intervention Type DRUG

Placebo

no active ingredient

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Active rheumatoid arthritis
* Incomplete response to methotrexate

Exclusion Criteria

* Must not be on biologic therapies
* No recent infections
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Arizona Arthritis & Rheumatology Associates, P.C.

Mesa, Arizona, United States

Site Status

Omega Research Consultants LLC

DeBary, Florida, United States

Site Status

Florida Arthritis Center

Lake Mary, Florida, United States

Site Status

Tampa Medical Group, PA

Tampa, Florida, United States

Site Status

American Health Network

Avon, Indiana, United States

Site Status

Best Clinical Trials, LLC (Administrative Only)

New Orleans, Louisiana, United States

Site Status

George Stanley Walker, MD

New Orleans, Louisiana, United States

Site Status

Majid Abdul Jawad, MD

New Orleans, Louisiana, United States

Site Status

The Arthritis and Osteoporosis Center of Maryland

Frederick, Maryland, United States

Site Status

University Physicians

Columbia, Missouri, United States

Site Status

University of Missouri-Columbia

Columbia, Missouri, United States

Site Status

Arthritis Center of Reno

Reno, Nevada, United States

Site Status

New Horizons Clinical Research

Cincinnati, Ohio, United States

Site Status

Arthritis Northwest

Spokane, Washington, United States

Site Status

Clínica Santa María, Sección Reumatología

Providencia, Santiago, RM, Chile

Site Status

Revmatologicka ambulance

Česká Lípa, , Czechia

Site Status

Revmatologicky ustav

Prague, , Czechia

Site Status

Revmatologicka ambulance

Prague, , Czechia

Site Status

Investigadores Clinicos Asociados

México, D.F., Mexico

Site Status

Krakowskie Centrum Medyczne NZOZ

Krakow, , Poland

Site Status

Zaklad Reumatologii i Immunologii Klinicznej

Poznan, , Poland

Site Status

Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny

Poznan, , Poland

Site Status

Inha University Hospital, Medicine/Rheumatology

Incheon, , South Korea

Site Status

Pusan National University Hospital, Rheumatology, Internal Medicine

Pusan, , South Korea

Site Status

Hospital Nuestra Señora de La Esperanza

Santiago de Compostela, A Coruña, Spain

Site Status

Complexo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Countries

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United States Chile Czechia Mexico Poland South Korea Spain

References

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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.

Reference Type DERIVED
PMID: 22382341 (View on PubMed)

Related Links

Other Identifiers

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2008-000327-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A6341009

Identifier Type: -

Identifier Source: org_study_id

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