Oribe), Kumamoto Saishunso Country wide Hospital (S. treated with CZP 200 mg Q2W plus MTX thereafter. Patients who exhibited an ACR20 response at weeks 12 or 14 but failed to achieve an ACR20 response at week 24 were assigned to Group II (= 19) and also received CZP 200 mg Q2W plus MTX. Patients who achieved an ACR20 response at week 12 or 14 as well as at week 24 were randomized 1:1 to either CZP 200 mg Q2W plus MTX (Group III, = 93) or CZP 400 mg Q4W plus MTX (Group IV, = 92) (Figure 1). Of importance, we established this dosing schedule so that the total dose received by patients in Groups III and IV over a 1-month period was the same. Open in a separate window Figure 1. J-RAPID OLE study design. The diagram depicts the breakdown of J-RAPID DB study patients into four groups for the OLE phase of the study. *Regardless of their initial DB phase group assignment, patients who achieved an ACR20 response at weeks 12 or 14 as well as at week 24 were randomized (1:1) to either CZP 200 mg Q2W (Group III, = 93) or CZP 400 mg Q4W (Group IV, = 92). Week 0 of the OLE phase of Groups II, III and IV (J-RAPID DB phase completers: hereinafter referred to as DB completers) corresponds to week 28 of the DB phase and week 0 of the OLE phase of Group I (early escape) corresponds to week 16 of the DB phase. Patients assigned to the placebo group during the DB phase were also included in this OLE study. Discontinuation of concomitant MTX was not permitted during the OLE phase up to week 52. A change in MTX dosage was permitted after week 24 of the OLE phase, if it was not greater than the original dose (6C8 mg/week). The Quinestrol outcome of the study was the measurement of continuous efficacy and safety monitoring during long-term treatment with CZP plus MTX. Efficacy outcomes included ACR20 response rates, and changes in Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR), the Short Form-36 Health Survey (SF-36) and Pain Visual Analog Scale (VAS) from J-RAPID pre-study baseline. In addition, to measure radiographic disease progression, changes in the modified Total Sharp Score (mTSS) from OLE study entry was assessed by linear extrapolation. Comprehensive disease control (CDC) was defined by the simultaneous achievement of the following three criteria: low disease activity (DAS28-ESR 3.2), functional remission (HAQ-DI 0.5) and radiographic non-progression (yearly mTSS 0.5). Similarly, comprehensive disease remission (CDR) was defined by simultaneously achieving the following: clinical remission (DAS28-ESR 2.6), functional remission (HAQ-DI 0.5) and radiographic non-progression (yearly mTSS 0.5). To calculate CDC and CDR for overall DB completers (= 204), yearly mTSS from J-RAPID pre-study baseline (linear extrapolation, with non-responder imputation for patients with no data) was used. Safety outcomes were reported for all patients who received at least one dose of CZP in the OLE study (= 285). The study Quinestrol was conducted in accordance with the ethical principles of the Declaration of Helsinki and with the Pharmaceutical Affairs Law Standards for the Conduct of Clinical Quinestrol Trials on Drugs (Ministry of Health, Labour and Rabbit Polyclonal to HSP90A Welfare Ordinance no. 28, 27 March 1997) and related notifications. Institutional review board approval was obtained at all centers and all patients provided written informed consent. Post-hoc analyses Since the OLE study included patients who received placebo during the J-RAPID DB phase, an additional post-hoc analysis of clinical efficacy was performed on patients who received CZP in the DB phase, to observe the effects of continuous CZP treatment during the combined DB and OLE phases of the study. This data set includes patients who were originally assigned to CZP 100, 200 and 400 mg treatment groups in the DB phase and completed the DB phase (CZP-DB completers). We focused on ACR20/ACR50/ACR70 response rates, DAS28-ESR scores, HAQ-DI scores and the disease activity state (high: DAS28-ESR.
Oribe), Kumamoto Saishunso Country wide Hospital (S