EUCTR2006-003146-41-DE进行中（未招募）不适用
A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD
Charité-Universitätsmedizin Berlin; Department of Rheumatology and Clinical Immunology0 个研究点开始时间: 2006年11月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Each patient must meet all of the following inclusion criteria to be enrolled into this study:
- •- Patients with definite RA referring to the ACR Classification Criteria of 1987 up to 1 year after first RA symptoms
- •- Age 18 to 70 years
- •- Has active disease at the time of randomization as indicated by 6 from 68 tender and 6 from 66 swollen joints and at least one of the following two criteria: Westergren erythrocyte sedimentation rate (ESR) ¸ 28 mm/hour od C-reactive protein (CRP) levels > 1.0 mg/dl.
- •- Has morning stiffness > 30 min.
- •- No current or prior therapy with DMARDs or biologics.
- •- NSAIDs and corticosteroids treatment has to be stable 2 weeks prior to
- •screening and during the trial with maximal · 10 mg/d prednisoloneequivalent.
- •- Is capable of understanding and signing an informed consent form
- •- Is able and willing to self-inject study drug or have a designee who can do so
- •- Is able and willing to take oral medication
- •- Is able to store injectable test article at 2± C to 8± C
- •- Sexually active women participating in the study must use a medically acceptable form of contraception for women. This includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- •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
- •Patients meeting any following exclusion criteria are not to be enrolled in
- •this study:
- •- Has significant concurrent medical diseases including cancer or a history of cancer (other than resected cutaneous basal and squamous cell carcinoma, in situ cervical cancer) in the last 5 years
- •- Has uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, other rheumatologic diseases than RA, or central nervous systems demyelinating events suggestive or multiple sclerosis
- •- Received anti-CD4, diphtheria interleukin-2 fusion protein, antiinterleukin- 6, rituximab or other immunsuppressive biologic before screening, and treatment with such agents if there are persistent signs of immunosuppression (with a subsequent abnormal absolute T-cell count) at screening count.
- •- Received any live (attenuated) vaccines within 4 weeks of screening visit.
- •- Received intra-articular corticosteroid injection within 4 weeks of screening.
- •- Received bolus intramuscular/intravenous treatment with corticosteroids (>10 mg prednisone or equivalent) within 4 weeks of screening visit
- •- Is taking > 10 mg/d prednisone or equivalent
- •- Has a history of confirmed blood dyscrasias
- •- Has a significant active infection or any underlying diseases that could predispose subjects to infections (e.g. history of recurring infections, leg ulcers, advanced or poorly controlled diabetes)
- •- Has active infection with Hep A, B, C virus, tuberculosis, chronic infections, latent tuberculosis (has to be excluded by Chest x-ray and PPD-Test according to Mendel-Mantoux); In case of latent tuberculosis isoniazid 300 mg for 10 months, starting 1 month prior to treatment is obligatory
- •- Has renal disease (creatine level > 175 ¹mol/L) or a history of known liver cirrhosis, fibrosis
- •- Has an abnormal liver function (AST, GGT, ALT ¸ 2 x upper limit of normal)
- •- Has a history of psychiatric disease that would interfere with the ability to comply with the study protocol.
- •- Is pregnant or breast-feeding
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