Health Condition 1: null- Arthritis, Rheumatoid
Conditions
Interventions
Intervention1: 5 mg BID CP-690,550: Drug: CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months
Intervention2: 10 mg BID CP-690,550: Experimental: CP-690,550
Oral tablets admini
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate or have received less than or equal to 3 doses of MTX, not stopped due to related adverse events. 2.Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria. 3.Active disease as defined by both greater than equal to 6 tender or painful joints on motion and greater than equal to 6 joints swollen, and either an erythrocyte sedimentation rate (ESR) is greater than 28 mm or a C-reactive protein (CRP) concentration is greater than 7 mg/dL
Exclusion criteria
Exclusion criteria: -Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L -History of any other rheumatic autoimmune disease other than Sjogren's syndrome -No malignancy or history of malignancy -History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug -No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparison of baseline and month 6 scores of PA hand and AP foot radiographs obtained, read and scored by a central facility;2.ACR 70 responder rate; 3.Incidence and severity of adverse events and clinical laboratory abnormalities, Summary of changes in physical examination compared to baseline by patient, Mean change from baseline in vital signs (BP, heart rate, and temperature) measurements; categorical summary of absolute vital signs and vital sign changes compared to baseline by patientTimepoint: 1. comparison of baseline and month 6; 2.month 6 and all other timepoints; 3.all time points;1. Comparison of baseline and month 6 scores of PA hand and AP foot radiographs obtained, read and scored by a central facility;2.ACR 70 responder rate; 3.Incidence and severity of adverse events and clinical laboratory abnormalities, Summary of changes in physical examination compared to baseline by patient, Mean change from baseline in vital signs (BP, heart rate, and temperature) measurements; categorical summary of absolute vital signs and vital sign changes compared to baseline by patientTimepoint: 1. comparison of baseline and month 6; 2.month 6 and all other timepoints; 3.all time points;1. Comparison of baseline and month 6 scores of PA hand and AP foot radiographs obtained, read and scored by a central facility;2.ACR 70 responder rate; 3.Incidence and severity of adverse events and clinical laboratory abnormalities, Summary of changes in physical examination compared to baseline by patient, Mean change from baseline in vital signs (BP, heart rate, and temperature) measurements; categorical summary of absolute vital signs and vital sign changes compared to baseline by patientTimepoint: 1. comparison of baseline and month 6; 2.month 6 and all other timepoints; 3.all time points;1. Comparison of baseline and month 6 scores of PA hand and AP foot radiographs obtained, read and scored by a central facility;2.ACR 70 responder rate; 3.Incidence and severity of adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Period radiographs will be obtained in all patients who discontinue from this study and enroll in open-label, long-term study A3921024. Changes in joint structure seen in A3921024 will be scored using validated method, similar to that used in this study.Timepoint: all time points;ACR 20, 50, and 70 responder ratesTimepoint: all time points;Change from baseline of scores of PA hand and AP foot radiographsTimepoint: month 12, 24;DAS 28-3 (CRP) and DAS 28-4 (CRP)Timepoint: all time points;DAS 28-3 (ESR) and DAS 28-4 (ESR) at participating sites (dependent upon availability of a local laboratory that can report ESR results directly to the central laboratory, to ensure blinding of data).Timepoint: all time points;Patients who drop out of A3921069 early will have radiographs obtained at last study visit, if previous radiographs were obtained more than 3 months prior to end of study visit.Timepoint: all time points;Physical function and patient reported outcomesTimepoint: various timepoints | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Germany, Hungary, India, Malaysia, Mexico, New Zealand, Other, Peru, Philippines, Poland, Republic of Korea, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, United States of America
Contacts
Public ContactRadhika Sreedharan
Representing Pfizer Limited
Outcome results
None listed