Clinical trial NCT00628095: Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: rheumatoid arthritis DMARD methotrexate
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Active rheumatoid arthritis
* Incomplete response to methotrexate

Exclusion Criteria:

* Must not be on biologic therapies
* No recent infections

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
timeFrame: Week 2, 4, 8
measure: Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 2, 4, 8, 12
measure: Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 2, 4, 8, 12
measure: Number of Tender/Painful and Swollen Joints
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Physician Global Assessment (PGA) of Arthritis
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Patient's Global Assessment of Arthritis
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Patient's Global Assessment of Arthritic Pain
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
timeFrame: Baseline, Week 2, 4, 8, 12
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Incidence of Withdrawal Due to Lack of Efficacy
timeFrame: Week 2, 4, 8, 12, 14
measure: Time to Withdrawal Due to Lack of Efficacy
timeFrame: Baseline up to Week 14
Other outcomes:
measure: CE-224,535 Plasma Concentrations
timeFrame: 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
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: DeBary
country: United States
facility: Omega Research Consultants LLC
state: Florida
city: Lake Mary
country: United States
facility: Florida Arthritis Center
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, PA
state: Florida
city: Avon
country: United States
facility: American Health Network
state: Indiana
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC (Administrative Only)
state: Louisiana
city: New Orleans
country: United States
facility: George Stanley Walker, MD
state: Louisiana
city: New Orleans
country: United States
facility: Majid Abdul Jawad, MD
state: Louisiana
city: Frederick
country: United States
facility: The Arthritis and Osteoporosis Center of Maryland
state: Maryland
city: Columbia
country: United States
facility: University Physicians
state: Missouri
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Reno
country: United States
facility: Arthritis Center of Reno
state: Nevada
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Providencia
country: Chile
facility: Clínica Santa María, Sección Reumatología
state: Santiago, RM
city: Ceska Lipa
country: Czechia
facility: Revmatologicka ambulance
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital, Medicine/Rheumatology
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital, Rheumatology, Internal Medicine
city: Mexico
country: Mexico
facility: Investigadores Clinicos Asociados
state: D.f.
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne NZOZ
city: Poznan
country: Poland
facility: Zaklad Reumatologii i Immunologii Klinicznej
city: Poznan
country: Poland
facility: Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny
city: Santiago de Compostela
country: Spain
facility: Hospital Nuestra Señora de La Esperanza
state: A Coruña
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.