EUCTR2006-001550-27-DE进行中（未招募）不适用
A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 293
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
- •Cooperative male or non-pregnant, non-lactating female patients at least 18 years of age. Who signed an informed consent before the initiation of any study procedure. Diagnosis of RA classified by ACR 1987 revised criteria (Appendix 3) and with symptoms for at least 3 months before randomization. Functional status class I, II or III classified according to the ACR 1991 revised criteria. Patients treated with MTX at the maximum tolerated and stable dose of =7.5 and =25 mg/week for
- •at least 12 weeks before randomization. Patients who failed any DMARDs (including biologic agents and any DMARD used in combination with MTX) will be allowed. For patients with previous treatment with biological therapy, the following wash-out periods are required before randomization: 3 days for Kineret® (anakinra) – with a terminal half-life of 4 to 6 hours (s.c. route). 4 weeks for Enbrel® (etanercept) – with a terminal half-life of 102 ± 30 hours (s.c. route). 8 weeks for Remicade® (infliximab) – with a terminal half-life of 8.0-9.5 days (i.v. infusion). 12 weeks for Humira® (adalimumab) – with a terminal half-life of 10-20 days (average 2
- •weeks) (s.c. route). 12 weeks for Orencia® (abatacept) – with a terminal half-life of 13.1 (8-25) days (i.v. infusion). 26 weeks for any other biologic – or 10 half-life, which ever is longer. Patients taking systemic corticosteroids have to be on a stable dose of =10 mg/d prednisone or equivalent for at least 4 weeks before randomization. Patients who are regularly using NSAIDs or COX-2 inhibitors or paracetamol/ acetaminophen as part of their RA therapy must be on a stable dose for at least 4 weeks before randomization. Pts taking NSAIDs or COX-2 inhibitors or paracetamol/ acetaminophen PRN within 2 wks before randomization have to stop their medication at least 24 hours before an ACR visit. Patients taking folic acid supplementation have to be on stable dose for at least 4 weeks before randomization. All current vaccinations, especially influenza and pneumococcal as clinically indicated. Weight =45 kg and BMI <34.0. Women of non-child-bearing potential (WOCBP), defined as all women physiologically not capable of becoming pregnant and females who are neither pregnant (ß-hCG serum pregnancy test negative) nor lactating, and are either: surgically sterilized (tubal ligation or hysterectomy), postmenopausal for at least 24 months past last natural menses, postmenopausal with last natural menses in the past 24 months, and with an FSH >40 IU/L and serum estradiol <18 pg/ml, or with an FSH =40 IU/L and serum estradiol =18 pg/ml, and using an acceptable form of birth control, will be eligible.
- •At baseline (Visit3)
- •1. Disease activity criteria of =6 out of 28 tender joints and =6 out of 28 swollen joints.
- •One of the following must also be present:
- •2. a) High sensivity C-reactive protein (hsCRP) concentration =10 mg/L
- •b) ESR =28 mm/1st hr
- •a) + b) are based on screening (SCR) values
- •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. History of hypersensitivity to study drug or to molecules with similar structures. Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization. Current use of DMARDs other than MTX. DMARDs include but are not limited to: biologic agents, thiolates (D-penicillamine, thiopronine), sulfasalazine, gold compounds, antimalarials, cyclosporine
- •A, azathioprine, leflunomide, and alkylating agents such as cyclophosphamide. If a patient has been discontinued from DMARDs, the patient should be off the agent for at least 4 weeks, except leflunomide which is 8 weeks. Patients with evidence of active pulmonary disease (e.g. tuberculosis, fungal diseases). Donation or loss of 400 mL or more of blood within 8 weeks before dosing. Who have had a live vaccination within 12 weeks before randomization, or are planning to have one during the study and not willing/able to postpone until study completion. With bacterial, fungal or viral infections at the time of enrollment, including patients with
- •evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. History of a positive purified protein derivative (PPD) of tuberculin skin test without action being taken such as documentation of prior BCG (bacille Calmette Guerin) immunization or the completion of a course of adequate chemoprophylaxis for tuberculosis with a negative chest X-ray. Patients requiring administration of antibiotics against latent tuberculosis, e.g., isoniazide(course of antibiotic therapy started prior to entering the study should not be prematurely terminated to alow inclusion in the study). Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty’s syndrome. With significant medical problems, including but not limited to the following: uncontrolled hypertension (=160/95 mmHg), congestive heart failure [New York Heart Association status of class III or IV (see Appendix 10)], type-I-diabetes (well controlled type-II-diabetes is allowed even when requiring insulin), thyroid disease (unless the patient is taking a stable dose of thyroid hormone for at least 12 weeks) before randomization. Other rheumatic diseases that could confound the evaluation of efficacy, including but not limited to primary fibromyalgia, ankylosing spondylitis, Lyme disease, adult JRA, systemic lupus erythematosus, gout and pseudo gout, vasculitis, psoriatic arthritis, reactive arthritis, primary Sjoegren’s Syndrome, and Behcet’s Syndrome. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol. History of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell carcinoma or squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, colon polyps with non-invasive malignancy that have been removed). Use of any investigational drug other than RA therapy and/or devices at the time of randomization, or within 30 days or 5 half- lives of randomization, whichever is longer.
研究者
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