Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Drug: CE-224,535Drug: Placebo
- Registration Number
- NCT00628095
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Active rheumatoid arthritis
- Incomplete response to methotrexate
- Must not be on biologic therapies
- No recent infections
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active CE-224,535 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12 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).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With American College of Rheumatology 70% (ACR70) Response Week 2, 4, 8, 12 ACR70 response: compared to baseline, \>=70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% 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).
Patient's Global Assessment of Arthritis Baseline, Week 2, 4, 8, 12 Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly.
Incidence of Withdrawal Due to Lack of Efficacy Week 2, 4, 8, 12, 14 Number of participants who withrew due to lack of efficacy were reported.
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8 Week 2, 4, 8 ACR20 response: compared to baseline, \>=20% 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).
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response Week 2, 4, 8, 12 ACR50 response: compared to baseline, \>=50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% 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).
Number of Tender/Painful and Swollen Joints Baseline, Week 2, 4, 8, 12 Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Baseline, Week 2, 4, 8, 12 DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Physician Global Assessment (PGA) of Arthritis Baseline, Week 2, 4, 8, 12 Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor. This was an evaluation based on the participant's disease signs, functional capacity and physical examination.
Patient's Global Assessment of Arthritic Pain Baseline, Week 2, 4, 8, 12 Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Baseline, Week 2, 4, 8, 12 Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0= least difficulty and 3= extreme difficulty.
C-Reactive Protein (CRP) Baseline, Week 2, 4, 8, 12 The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time to Withdrawal Due to Lack of Efficacy Baseline up to Week 14
Trial Locations
- Locations (26)
University Physicians
🇺🇸Columbia, Missouri, United States
University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Arthritis Center of Reno
🇺🇸Reno, Nevada, United States
Clínica Santa María, Sección Reumatología
🇨🇱Providencia, Santiago, RM, Chile
Investigadores Clinicos Asociados
🇲🇽Mexico, D.f., Mexico
George Stanley Walker, MD
🇺🇸New Orleans, Louisiana, United States
Majid Abdul Jawad, MD
🇺🇸New Orleans, Louisiana, United States
Hospital Nuestra Señora de La Esperanza
🇪🇸Santiago de Compostela, A Coruña, Spain
Arizona Arthritis & Rheumatology Associates, P.C.
🇺🇸Mesa, Arizona, United States
Krakowskie Centrum Medyczne NZOZ
🇵🇱Krakow, Poland
Revmatologicka ambulance
🇨🇿Praha 4, Czechia
Omega Research Consultants LLC
🇺🇸DeBary, Florida, United States
Tampa Medical Group, PA
🇺🇸Tampa, Florida, United States
Florida Arthritis Center
🇺🇸Lake Mary, Florida, United States
American Health Network
🇺🇸Avon, Indiana, United States
The Arthritis and Osteoporosis Center of Maryland
🇺🇸Frederick, Maryland, United States
Arthritis Northwest
🇺🇸Spokane, Washington, United States
Revmatologicky ustav
🇨🇿Praha 2, Czechia
Inha University Hospital, Medicine/Rheumatology
🇰🇷Incheon, Korea, Republic of
Pusan National University Hospital, Rheumatology, Internal Medicine
🇰🇷Pusan, Korea, Republic of
Zaklad Reumatologii i Immunologii Klinicznej
🇵🇱Poznan, Poland
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny
🇵🇱Poznan, Poland
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Best Clinical Trials, LLC (Administrative Only)
🇺🇸New Orleans, Louisiana, United States