Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA

Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom0 个研究点目标入组 72 人开始时间: 2010年2月18日最近更新: 2012年9月3日

试验速览

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•Inclusion Criteria for the Open-label Period (Period 1):
•Subject must meet all of the following conditions in order to be enrolled in the study:
•1. Men and women have a diagnosis of RA based on the ACR Revised Criteria for RA.
•2. Subject has a current DAS28 =3.2.
•3. Subject is currently receiving treatment with sc ETN, either 25 mg BW or 50 mg QW, for a minimum of 14 months at baseline
•4. Subject is currently receiving oral, sc or im MTX, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.
•Inclusion Criteria for the Double-Blind Randomized Period (Period 2)
•1. Subject has completed open-label period 1 and has had DAS28 = 3.2 at all visits during period 1 and at randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 67
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Exclusion Criteria for the Open-Label Period (Period 1)
•1· Subject has earlier had an attempt of discontinuing ETN for reasons of remission or LDA state.
•2. Subject has received any disease-modifying anti-rheumatic drug (DMARD), other than MTX, a dose of prednisone (or equivalent) >7.5 mg/day or has received ia, iv, im, or sc corticosteroid within one month before baseline.
•Exclusion Criteria for the Double-Blind Randomized Period 2
•1. Subject has used prohibited concomitant medication in period 1 or has not attended all visits in Period 1.
•For additional criteria, see protocol

发起方

Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom