None listed
Conditions
Interventions
Group 1 Type of group
CP-690,550 5 mg PO BID open label
Group 2 Type of group
CP-690,550 10 mg PO BID open label
may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Evidence of an informed consent document signed and dated personally, indicating that the patient (or his legal representative) has been informed of all relevant aspects of the trial. • The patient must have at least the recognized legal age of consent or provide their written consent along with the consent signed by their recognized legal representative. • In the opinion of the researcher, the patient must have sufficient data on AR disease activity to justify the use of CP-690,550 as DMARD. • Previously, the patient must have completed a participation in a randomized qualification study of CP-690,550 for the treatment of RA or required the early suspension of treatment in a randomized qualification study for some reason other than a serious adverse event related to CP-690,550 with the clinical approval of the Pfizer study. • No evidence of Mycobacterium tuberculosis (TB) infection active, latent or improperly treated.
Exclusion criteria
Exclusion criteria: • Evidence of hematopoietic disorder or a hemoglobin level <9 gm / dL or hematocrit <30% at the selection visit or in the 3 months prior to the baseline visit. • Absolute leukocyte count (RL) <3.0x10 ^ 9 / L (<3,000 / mm ^ 3) or absolute neutrophil count <1.2 x10 ^ 9 / L (<1,200 / mm ^) at the selection visit or in the 3 months prior to baseline • Thrombocytopenia, defined by a platelet count <100 x 10 ^ 9 / L (<100,000 / mm ^ 3) at the selection visit or in the 3 months prior to baseline. • Estimated creatinine clearance <40 mL / hr using the Cockroft Gault equation (see Appendix D) in the selection visit. • Total bilirubin, AST or ALT greater than 1.5 times the upper limit of normal at the selection visit. • Pregnant or nursing woman. • Current or recent history of kidney, liver, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease clinically significant and uncontrolled. • History of any other autoimmune rheumatic disease, apart from Sjogren´s syndrome. • History of infected joint prosthesis at any time, with the prosthesis still in situ. • History of lymphoproliferative disorder such as lymphoproliferative disorder related to Epstein Barr virus (EBV), history of lymphoma, leukemia or signs and symptoms suggestive of current lymphatic disease • History of recurrent herpes zoster (more than one episode) or disseminated herpes zoster (a single episode) or disseminated herpes simplex (a single episode). • Patient with any infection that requires hospitalization, parenteral antimicrobial therapy or that the investigator considers opportunistic) in the 6 months prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each. Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell Measure:Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Timepoints:Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug ; Outcome name:Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114. Measure:The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Timepoints:Includes AEs for every visit and up to 999 days after last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subjects Global Assessment of Arthritis, Physicians Global Assessment of Arthritis, Subjects Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables. Measure:Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses Timepoints:Every visit until study completion ; Outcome name:Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula. The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of 5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission. Measure:Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 Timepoints:Every visit until study completion ; Outcome name:Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduct | — |
Countries
Argentina, Australia, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Finland, France, Germany, Greece, Hungaria, India, Ireland, Italy, Ivory Coast, Korea South, Malasya, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactMartin Nizama
PFIZER S.A.
Outcome results
None listed