| Exclusion Criteria: | 1) The subject has a significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring antibiotics; clinically significant cardiac disease (class III or IV of the New York Heart Association classification);^39 unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; (continues in next exclusion criteria)
2) (Continued from exclusion #1) uncontrolled hypertension (systolic blood pressure >160 mm Hg, diastolic BP > 100 mmHg, found on two consecutive measurements separated by a 1-week period) despite two anti-hypertensive medications; clinically significant cardiac arrhythmia; or uncontrolled diabetes.
3) The subject has known or tests positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
4) The subject has evidence of central nervous system (CNS) metastasis.
5) The subject has received monoclonal antibodies within 6 weeks of study entry.
6) The subject is pregnant (confirmed by beta human chorionic gonadotrophin [betaHCG]) or lactating.
7) Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone), including but not limited to the following, will be excluded: pharmacologic doses of systemic steroids except as used to treat or prevent an infusion or allergic reaction to KW-0761 (topical steroids, inhalation steroids and replacement doses of systemic steroids are permitted); (continues in exclusion 8).
8) (continued from exclusion #7) methotrexate; azathioprine; intravenous immunoglobulin; cyclophosphamide; cyclosporine; mycophenolate; infliximab; etanercept; leflunomide; adalimumab; abatacept; rituximab; anakinra; interferon-alpha; interferon-beta; IL-2 and natalizumab. Subjects on any of the foregoing agents within 4 weeks of their first dose of KW-0761 are also excluded.
9) The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.
10) The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
11) Subjects with active herpes simplex or herpes zoster. Subjects with a history of herpes zoster who have had an outbreak within the last year will also be excluded. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, should continue to take the prescribed medication for the duration of the study.
12) Subjects with known autoimmune diseases, including, but not limited to the following, will be excluded: multiple sclerosis; Grave's disease; vasculitis; systemic lupus erythematosis; rheumatoid arthritis; systemic sclerosis; myasthenia gravis; ankylosing spondilitis; Wegener's granulomatosis; ulcerative colitis; Crohn's disease; psoriasis requiring systemic therapy; pemphigus; temporal arteritis; uveitis; dermatomyositis; Sjogren's syndrome; (continues in exclusion 13)
13) (Continued from exclusion # 12) Goodpasture's syndrome; interstitial pneumonitis; interstitial nephritis; and Henoch-Schoenlein purpura. Subjects with a history of any of these disorders will also be excluded. Subjects with Hashimoto's thyroiditis controlled with medication are eligible for enrollment. |