For the same comparison on a qualitative variable, the chi square

For the same comparison on a qualitative variable, the chi square or Fisher exact test was used. The rates of patients achieving the var ious ACR response variables after 12 weeks of treatment are presented in terms of number and percent age of patients. Patients were assigned to either 3 or 6 mg kg per day treatment groups Compound C based upon a randomisation sched ule generated for packaging and labelling by the Inhibitors,Modulators,Libraries Biostatistics Section of AB Science. Individual treatment doses to be administered were supplied in sealed envelopes to be opened by the investigator at the time of inclusion. Patients received Inhibitors,Modulators,Libraries the treatment from the investigator on an open basis. Due to the relatively high patient dropout rate of this study, analysis was conducted on two different datasets, one with an imputation of missing values according to the last observation carried forward methodology and the other in the absence of Inhibitors,Modulators,Libraries data imputation.

Analysis for efficacy was performed on a modified intention to treat population and per protocol popu lation. The ITT population was defined as those patients who had received at least one dose of masitinib and who had undergone Inhibitors,Modulators,Libraries at least one post baseline assessment of efficacy. The PP population was defined as a subgroup of the ITT pop ulation that in addition had presented no major protocol devi ations and had completed at least 28 days of treatment exposure. Results Baseline characteristics and participant flow Between December 2004 and March 2006, a total of 43 patients were enrolled in the study.

Participants were ran domly assigned to one of two initial treatment groups, receiv ing a masitinib dosage of either 3 mg kg per day or 6 mg kg per day. Of these, 27 43 patients Inhibitors,Modulators,Libraries com pleted the study, with 21 43 patients entering the studys extension phase. Of the 16 patients who http://www.selleckchem.com/products/Tipifarnib(R115777).html withdrew before completion of the 12 week study period, occurrence of an AE was cited as the primary cause of discontinuation. Participant baseline characteristics, disposition and dosing history are presented in Table 1 according to the randomised dose ranging treatment groups. Baseline values of several efficacy parameters were higher in the 6 mg kg per day group compared with the 3 mg kg per day group, for example, DAS28 was, respectively, 7. 1 versus 6. 1 , CRP was 62 versus 26 mg litre, swollen joint count was 22. 1 versus 15. 3, previ ous anti TNFwas 67% versus 36% and Health Assessment Questionnaire score was 2. 2 versus 1. 9. Hence, the 6 mg kg per day initial dosage arm had a higher baseline of disease severity. Three patients were excluded from the randomised population due to lack of efficacy data following baseline, thus, according to our ITT population definition, the resulting ITT population was n 40.

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