EUCTR2007-007539-14-PL进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
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.Provision of informed consent (including PK subset consent, as applicable).
- •2.Male or female aged 18 or over.
- •Note: Women of child-bearing potential may be included only if highly effective contraception is in place (see Section 3.3.4 and Appendix K) and patients are fully aware of the information relating to the potential for reprotoxicity as detailed in the informed consent form. Males who are involved in the study must agree to abstain from procreative sex during the study and for 12 weeks after the last dose of study medication.
- •3.Diagnosis of RA after the age of 16 according to the revised (1987) criteria of the American College of Rheumatology (see Appendix E).
- •4.Have active RA defined as:
- •-=4 swollen joints and =6 tender/painful joints
- •and either:
- •ESR =28 mm/h or, CRP =10 mg/L.
- •5.At least one of the following:
- •-Documented history of positive rheumatoid factor
- •-Current presence of rheumatoid factor
- •-Baseline radiographic erosion
- •-Presence of serum anti-cyclic citrullinated peptide antibodies (anti-CCP).
- •6.Oral or subcutaneous or intramuscular methotrexate for at least 6 months prior to randomisation. The dose and means of administering methotrexate must have been stable between 5 mg and 25 mg per week for at least 6 weeks prior to randomisation.
- •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
- •1.Pregnant or lactating females
- •2.Any systemic inflammatory condition in addition to RA that may interfere with the interpretation of the outcome data (examples include but are not limited to polymyalgia rheumatica, giant cell [including temporal] arteritis, reactive arthritis).
- •3.Current chronic pain disorders, including fibromyalgia and chronic fatigue syndromes.
- •4.American College of Rheumatology functional class IV (see Appendix F) or wheelchair/bed-bound.
- •5.Patient unable to comply with the local approved product information for etanercept. Note: any patients randomised to receive etanercept will be confirmed as negative for LTBI prior to initiation of treatment. If the patient has had a negative TB test in the month prior to Visit 1, the result of that test will stand and the test does not need to be repeated. Patients who have a positive test result should be discontinued, see Section 3.3.5.1).
- •Note: Where a local label is not available, then the label applicable to the supplied drug will apply.
- •6.Patients who have previously failed to respond to treatment with more than 1 biological agent.
- •7.Patients who in the opinion of the investigator have active TB as defined by clinical history and/or chest X-ray.
- •8.Patients who fail to comply with or are unlikely to stay compliant with the restrictions on prior and concomitant medication usage as provided in Section 3.7.
- •9.Clinical or biochemical evidence of active infection with hepatitis B or hepatitis C (carriers ie, those with positive serology but no evidence of active disease may be included).
- •10.Values of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin >2 x upper limit of normal (ULN) at Visit 1.
- •Note: If a potential patient has liver function only marginally outside these limits (as judged by the investigator), the patient may at the investigator’s discretion be brought back to study centre and retested not less than 2 weeks later and may be enrolled in the trial if the test(s) is then within the prescribed limit.
- •11.History of excessive alcohol consumption or chronic alcohol induced disease.
- •12.Patients who, in the opinion of the investigator, are at increased risk of ventricular arrhythmias, as suggested by (but not limited to):
- •-QTc at enrolment >450 ms, persistent on 2 repeated ECG recordings 30 minutes apart (subject to cardiological review if clinical doubt over machine calculated value)
- •-Other clinically significant ECG abnormality suggestive of clinically important underlying cardiovascular disease, including previous myocardial infarction; lack of sinus rhythm (ventricular ectopics allowed unless previously documented to be >100 per hour)
- •-Personal or familial history of long QT syndrome
- •-Personal history of clinical coronary heart disease (including angina) or congestive heart failure
- •-Clinical history of non-sustained or sustained ventricular tachycardia
- •-Visit 1 potassium outside normal range (subject to repeat if haemolysis etc, is suspected). Hypokalaemia may be treated if clinically indicated by potassium supplementation and patients may be included provided this is adequately corrected within the allowed screening period
- •-Patients with a clinically significant left ventricular hypertrophy, as determined by ECG, ie, V1/2 + V5/6 =35 mm
- •-Patients with brady-tachy syndrome that is not under satisfactory control
- •-Patients who, in the opinion of the investigator, have a history of clinically significant valvular heart disease.
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