NL-OMON37109撤回3 期
A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability, and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- TEVA Pharma
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged 18-80 years (inclusive) at screening.
- •2. Rheumatoid arthritis for at least 6 months, as defined by the Revised Criteria ACR 1987 (adult onset RA).
- •3. Severe, active, seropositive (plasma RF level of at least 20 IU/mL and/or ACPA/anti-CCP positive) disease as defined by the following, revealed in screening tests:
- •Active disease defined as presence of at least 8 swollen and 8 tender joints (at the screening visit).
- •A serum CRP level of >=15 mg/L (>=1.5 mg/dL) and/or an ESR (Westergren method) of >=28 mm per hour at screening.
- •4. Inadequate response or intolerance DMARDs other than MTX and/or TNFi therapies (1 or more).
- •5. Treatment with MTX (10 to 25 mg/week) for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dosage that will remain stable throughout the study period
- •(up to Week 48).
- •6. Willing and able to provide written informed consent prior to performing study procedures.
- •7. Women or men of reproductive potential must use (or have his/her partner use) effective contraceptive methods starting from screening and until 12 months following the last infusion (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner*s vasectomy or double-barrier method [condom or diaphragm with spermicide]).
排除标准
- •1. Documented rheumatic autoimmune disease or inflammatory joint disease other than RA (eg, psoriatic arthritis or ankylosing spondylitis).
- •2. Significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty*s syndrome) or American Rheumatism Association (ARA) functional class IV disease.
- •3. Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins.
- •4. Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy or clinically significant infection, at screening and/or at Day 1 (baseline), or a history of recurring or
- •chronic infections or with underlying conditions that may, according to the Investigator*s judgment, further predispose subjects to serious infection.
- •5. Known immunodeficiency syndrome, including total immunoglobulins (IgG, IgA and IgM) lower than the lower limit of normal (LLN).
- •6. Positive human immunodeficiency virus (HIV) serology (in case of positive result an additional HIV RNA test should be performed), positive hepatitis B surface antigen or positive
- •hepatitis C antigen (in case of positive result an additional hepatitis C virus [HCV] RNA test should be performed).
- •7. History of cancer in the past 5 years prior to screening (except basal-cell carcinoma of the skin that has been excised).
- •8. Immunization with live viral vaccines less than 4 weeks prior to Day 1 (baseline) and/or planned live viral vaccination during the core study period and/or the anticipated B cell depletion period.
- •9. Use of oral/intravenous/intramuscular systemic corticosteroids
- •Oral corticosteroids at a dose higher than 10 mg prednisone daily (or an equivalent dose of other oral steroids) within the 4 weeks prior to screening and between screening and Day 1
- •Oral corticosteroids at a dose equal to or lower than 10 mg prednisone daily (or an equivalent dose of other oral steroids) that were not kept at a stable dose within 4 weeks prior to screening and between screening and Day 1 (baseline).
- •Use of intravenous/intramuscular/intra-articular or parenteral glucocorticoids <4 weeks prior to screening.
- •10. Use of any cytotoxic therapies and immunosuppressants, (except for allowed dosage of MTX) or other DMARDs within the 4 weeks prior to screening or between screening and Day 1
- •(baseline).
- •11. Prior use of MabThera (rituximab) and/or participation in a previous clinical trial with the investigational study drug TL011.
- •12. Use of TNFi and any other biological agent for the treatment of autoimmune diseases less than 8 weeks prior to Day 1 (baseline) or use of etanercept and anakinra less than 4 weeks prior to Day 1.
- •13. Participation in a previous clinical trial and/or use of an investigational drug within 90 days of screening.
- •14. Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation based on the Investigator*s judgment. Conditions may include cardiovascular disease (including severe heart failure of New York Heart Association [NYHA] class IV or severe, uncontrolled cardiac disease) pulmonary, hepatic, renal, or neurological disease as determined by medical history, physical examination, laboratory tests, chest X-ray, or ECG.
- •15. Likely to be non-compliant or uncooperative during the study in
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A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-005021-48-BGTeva Pharmaceutical Industries544