EUCTR2005-002660-29-HU进行中（未招募）不适用
A Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1] Women and men who are 18 to 75 years of age.
- •[2] Women must not be at risk to become pregnant during study participation.
- •[3] Diagnosis of RA according to the American Rheumatism Association (ARA) 1988 Revised Criteria for the Classification of RA.
- •[4] Regular use of MTX (7.5 mg to 25 mg weekly) for at least 3 months (with stable doses for at least 2 months) at the time of study entry. Additional oral DMARDs are allowed, but not required.
- •[5] Active RA disease as defined by the following:
- •- Presence of =3 swollen joints based on 28 diarthrodial joint assessment AND
- •- Presence of =3 tender joints based on 28 diarthrodial joint assessment
- •- Presence of =6 swollen joints based on 66 diarthrodial joint assessment (=5 of which must be among those included in the 28 joint count), AND
- •- CRP measurement >2x upper limit of normal (ULN) (0.574 mg/dL), AND
- •- At least one of the following two criteria:
- •---- =6 tender joints based on 68 diarthrodial joint assessment (=5 of which must be among those included in the 28 joint count)
- •---- =45 minutes of early morning stiffness
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[12] History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data.
- •[16] Evidence of systemic conditions associated with inflammation other than RA.
- •[17] History of insulin-requiring diabetes mellitus.
- •[18] Frequent exacerbations of asthma or chronic obstructive pulmonary disease.
- •[19] History of respiratory infection within two weeks of study entry or a history of serious bacterial infections within two months of study entry.
- •[20] Prior exposure to these agents within the following timeframe:
- •- Anakinra (Kineret ® ) within 4 weeks of enrollment
- •- Etanercept (Enbrel ® ) within 4 weeks of enrollment
- •- Adalimumab (Humira ® ) within 8 weeks of enrollment
- •- Infliximab (Remicade ® ) within 8 weeks of enrollment
- •- Regeneron IL-1 Trap within 8 weeks of enrollment
- •- AMG108 (Anti-IL-1 receptor type 1 [IL-1R1] antibody) within 16 weeks of enrollment.
- •[21] In the judgment of the investigator, history of an inadequate therapeutic response to an adequate trial (at least one month) of a biologic agent targeting either IL-1 or TNF (Part B only).
- •[22] Prior use of therapies targeting B cells within the past one year (such as Lymphostat B, LY2127399, rituximab [Rituxan ™] or cyclophosphamide [Cytoxan ® ]) unless the investigator determines that the patient’s B cell counts have recovered.
- •[23] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication, or within 60 days of the time of study entry for any RA experimental agent.
- •[24] Use of any other biologic therapy for RA not specified by the protocol (for example, abatacept, anti-IL-6 receptor antibody, or anti-IL-15 antibody) within 5 half-lives of the last dose of the biologic agent (minimum 60 days).
- •[25] Prior serious systemic allergic reactions to biologic therapy.
- •[26] Use of other DMARDs other than MTX, hydroxychloroquine and sulfasalazine, in the 8 weeks prior to entry into this study (12 weeks for leflunomide).
- •[27] Received a live vaccination (for example, FluMist ®) within 3 months of study entry, or who are anticipated to receive live vaccines during the time period of participation in this study.
- •[28] Hemoglobin <10.0 g/dL.
- •[30] Liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) >1.2X ULN. The AST and ALT may be repeated once if the initial result exceeds this limit, and the lesser value accepted if it meets this criterion.
- •[31] Evidence of hepatitis C and/or positive hepatitis C antibody.
- •[32] Evidence of hepatitis B and/or positive hepatitis B surface antigen.
- •[33] Evidence of human immunodeficiency virus (HIV) and/or positive test for antibodies to HIV.
- •[34] Evidence of tuberculosis (TB) as documented by positive tuberculin skin test (either history of past positive or screening tuberculin skin test >5 mm), medical history or chest radiograph. Study participants must have a screening purified protein derivative (PPD) test performed at screening and will be excluded if positive.
- •[35] Women who are pregnant or become pregnant during the study, or are breast-feeding.
研究者
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