NL-OMON36644撤回不适用
A PHASE I/II, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY, WITH A SINGLE ASCENDING DOSE PART FOLLOWED BY A MULTIPLE ASCENDING DOSE PART, EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF INTRAVENOUS ALX-0061 IN PATIENTS WITH RHEUMATOID ARTHRITIS - ALX-0061 phase I/II, SAD and MAD study in RA patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Ablynx
- 入组人数
- 10
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. Gender: male and female
- •2. Age: 18-80 years, inclusive
- •3. Body mass index (BMI): <35.0 kg/m2
- •4. Diagnosed with RA according to the 2010 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria for at least 6 months prior to randomization
- •5. Inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) (including methotrexate [MTX]). Treatment with MTX for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dose, that will remain stable throughout the study period
- •6. DAS28 ><= 2.4
排除标准
- •1. A documented history of an autoimmune disease other than RA (other than secondary Sjögren*s syndrome)
- •2. Functional class IV by ACR classification
- •3. Any new/additional biologic DMARD therapy, cytotoxic drugs and immunosuppressants within four weeks prior to screening, and between screening and Day 1 with the exception of ALX-0061
- •4. Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray
- •5. Female patients who are pregnant during the study, or are breastfeeding
- •6. History of anaphylactic reactions to protein therapeutics
- •7. Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the SAD part of this study and who are eligible to participate in the MAD part
- •8. Donation of more than 300 mL of blood within 60 days prior to drug administration
- •9. Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for non-melanoma skin cancer or resected carcinoma in situ
- •10. Any current or recent (within 4 weeks prior to first dose) signs or symptoms of infection that requires parenteral antibiotic administration, any known active viral infection (hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]) that would impair the participation in the study
- •11. Major surgery (including joint surgery) within 8 weeks prior to screening and hospitalization for a clinically relevant event within the 4 weeks prior to screening
- •12. Any other disease, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications
- •13. Administration of a live, attenuated vaccine within 1 month before dosing with ALX-0061, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
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