Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis (RA) Subjects Who Are Sub-Optimal Responders to Etanercept 50 mg Once Weekly (QW)
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The purpose of this study objective will be to evaluate the efficacy and safety of etanercept 50 mg BIW in RA subjects who showed a sub-optimal response to standard dose etanercept (50 mg QW) and concomitant methotrexate therapy.
A Multi-center, Randomized, Double-Blind, Active-Controlled Study Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis Subjects Who Are Sub-optimal Responders to Etanercept 50 mg Once Weekly (QW)
Study Start Date :
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Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
Secondary Outcome Measures :
Proportion of subjects who achieve American College of Rheumatology (ACR) 20, 50, and 70 responses at Weeks 12 and 24
Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria at Week 24 and the proportion achieving clinical remission (DAS28<2.6) at Weeks 12 and 24
Changes from baseline with respect to the DAS28 score and ACR score (including HAQ) criteria at Weeks 12 and 24
Changes from baseline in patient-reported outcomes as measured by the SF-36 at Weeks 12 and 24
Proportion of etanercept 50mg BIW responders at Week 12 who mantain a clinical improvement with etanercept 50mg QW (defined as no DAS28 increase of greater than 0.6 from Week 12) at Week 24
Safety (SAEs and AEs) in three study periods (4-week open label run-in period, 12-week double blinded period A, and 12-week open-label period B)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of Rheumatoid Arthritis
RA with a disease duration > 6 months
Current and prior but continuous etanercept (50 mg weekly) treatment for at least 5 months prior to screening
Subjects must be receiving methotrexate (MTX) at a stable dose > 15 mg/week at least 4 weeks prior to screening
Sub-optimal response to etanercept defined by the presence of the following criteria (based on 28 joint count) at screening: 5 or more swollen joints and 5 or more tender joints
Subjects who are currently receiving oral corticosteroids must be on a dose equivalent to prednisone less than or equal to 10 mg/day at screening
Subjects who are currently receiving non-steroidal anti-inflammatory drugs (NSAIDs), must be on a stable dose for at least 2 weeks prior to screening
Subjects who are currently receiving DMARD therapy (including sulfasalazine, hydroxy-chloroquine and leflunomide), must be on a stable dose for at least 4 weeks prior to screening
Nursing mothers, female subjects planning on becoming pregnant, or male subjects planning a pregnancy with their spouse/partner while in the study
ACR functional class IV
Receipt of any investigational drug or biologic within 4 weeks of study drug initiation
Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
History of alcohol or drug abuse within 12 months of screening visit
Severe comorbidities including: History of cancer (other than resected cutaneous basal and squamous cell carcinoma, and in situ cervical cancer) within 5 years of screening visit. Documentation of disease-free state since treatment required; Diagnosis of Class III or IV congestive heart failure (CHF) or myocardial infarction (MI) within 12 months of screening; Unstable or stable angina pectoris; Uncontrolled hypertension (defined as systolic blood pressure measurement of greater than 180 mm Hg or a diastolic blood pressure of greater than 110 mm Hg); Oxygen-dependent pulmonary disease; Known HIV-positive status or other immunodeficiency syndromes; Chronic hepatitis B (HbsAg) or C (HCV); Systemic lupus erythematosus (SLE); CNS demyelinating events suggestive of multiple sclerosis; Presence of active infection or any underlying diseases that could predispose subjects to infection (e.g., history of recurrent infections, non-healing leg ulcers, advanced or poorly controlled diabetes); Active or prior history of tuberculosis (or known exposure).