ISRCTN36745608已完成不适用
A controlled randomised double-blind multicentre study comparing two therapy strategies in disease modifying anti-rheumatic drug-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 versus methotrexate monotherapy
Charité - University Medicine Berlin (Germany)0 个研究点目标入组 180 人开始时间: 2006年8月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
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
- 性别
- All
入选标准
- •Each patient must meet all of the following inclusion criteria to be enrolled into this study:
- •1. Patients with definite RA referring to the American College of Rheumatology (ACR) Classification Criteria of 1987 up to one year after first RA symptoms
- •2. Aged 18 to 70 years
- •3. Has active disease at the time of randomisation as indicated by: six from 68 tender and six from 66 swollen joints and at least one of the following two criteria:
- •3.1. Westergren erythrocyte sedimentation rate (ESR) of 28 mm/hour
- •3.2. C-reactive protein (CRP) levels more than 1.0 mg/dl
- •4. Has morning stiffness for longer than 30 minutes
- •5. No current or prior therapy with Disease Modifying Anti-Rheumatic Drugs (DMARDs) or biologics
- •6. Non steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids treatment has to be stable two weeks prior to screening and during the trial with maximal less than or equal to 10 mg/d prednisolone equivalent
- •7. Is capable of understanding and signing an informed consent form
- •8. Is able and willing to self-inject study drug or have a designee who can do so
- •9. Is able and willing to take oral medication
- •10. Is able to store injectable test article at 2°C to 8°C
- •11. 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
排除标准
- •Patients meeting any following exclusion criteria are not to be enrolled in this study:
- •1. 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 five years
- •2. 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
- •3. Received anti-CD4, diphtheria interleukin-2 fusion protein, anti-interleukin-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
- •4. Received any live (attenuated) vaccines within four weeks of screening visit
- •5. Received intra-articular corticosteroid injection within four weeks of screening
- •6. Received bolus intramuscular/intravenous treatment with corticosteroids
- •(more than 10 mg prednisone or equivalent) within four weeks of screening visit
- •7. Is taking more than 10 mg/d prednisone or equivalent
- •8. Has a history of confirmed blood dyscrasias
- •9. 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)
- •10. Has active infection with Hepatitis A, B or C virus, tuberculosis, chronic infections, latent tuberculosis (has to be excluded by Chest X-ray and Purified Protein Derivative [PPD] Test according to Mendel-Mantoux), in case of latent tuberculosis
- •isoniazid 300 mg for ten months, starting one month prior to treatment is obligatory
- •11. Has renal disease (creatine level more than 175 µmol/L) or a history of known liver cirrhosis, fibrosis
- •12. Has an abnormal liver function (aspartate aminotransferase [AST], gamma-glutamyl transpeptidase [GGT], alanine aminotransferase [ALT] two times the upper limit of normal [ULN])
- •13. Has a history of psychiatric disease that would interfere with the ability to comply with the study protocol
- •14. Is pregnant or breast-feeding
研究者
相似试验
已完成
不适用
A double-blind multi-centre randomised controlled trial to investigate the effectiveness of methylprednisolone injections in the treatment of Morton's neuromaMorton's neuromaNervous System DiseasesMononeuropathies of lower limbISRCTN13668166Queen Margaret University (UK)150
已完成
4 期
An intervention study to determine if a longer duration of antibiotics (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised for pneumoniaPneumonia in childrenRespiratory - Other respiratory disorders / diseasesInfection - Studies of infection and infectious agentsPublic Health - Other public healthACTRN12616000046404Menzies School of Health Research324
招募中
3 期
Preventing recurrent acute lower respiratory infections in young Indigenous children using long-term, once-weekly azithromycin: a multicentre randomised controlled trialAcute lower respiratory infection in childrenRespiratory - Other respiratory disorders / diseasesInfection - Other infectious diseasesACTRN12619000456156Menzies School of Health Research160
尚未招募
2 期
idocaine (lignocaine) for Neuropathic Cancer Pain – Feasibility study (LiCPain)europathic Cancer PainACTRN12617000747325niversity of Technology Sydney36
进行中（未招募）
1 期
A multicentre double-blind randomised controlled trial to assess the clinical- and cost-effectiveness of facet- joint injections in selected patients with non-specific low back pain: A feasibility study.on-specific low back pain of more than three months' durationEUCTR2014-003187-20-GBBarts Health NHS Trust16