NCT00152386已完成3 期
A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 950
- 试验地点
- 75
- 主要终点
- To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
研究概览
简要总结
Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, aged at least 18 years old at the Screening visit.
- •A clear chest X-ray within 3 months prior to Baseline visit.
- •A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
- •Active RA disease at Screening and Baseline as defined by:
- •≥9 tender joints.
- •≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
- •≥30 mm/hour ESR (Westergren), or
- •CRP >15 mg/L.
- •Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly.
- •Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.
排除标准
- •A diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis.
- •A secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.
- •A history of an infected joint prosthesis at any time with prosthesis still in situ.
- •Does not meet exclusionary concomitant medication criteria.
- •A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
- •Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
研究组 & 干预措施
未命名试验
干预措施: Certolizumab pegol (CDP870) (Drug)
结局指标
主要结局
To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
次要结局
- Change from Baseline in mTSS at week 24, Change from Baseline in HAQ-DI at weeks 24 and 52, ACR20 responder rate at week 52, ACR50 and ACR70 responder rate at weeks 24 and 52
研究者
研究点 (75)
Loading locations...
相似试验
已完成
3 期
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With DermatomyositisDermatomyositisNCT05437263Priovant Therapeutics, Inc.241
已完成
3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With IvacaftorCystic FibrosisNCT02347657Vertex Pharmaceuticals Incorporated510
撤回
3 期
A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label ExtensionAlzheimer's DiseaseNCT04187547Cerecin
招募中
3 期
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACSAcute Coronary SyndromeNCT05918861DalCor Pharmaceuticals2,000
终止
3 期
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial FibrillationParoxysmal Atrial FibrillationNCT05039359InCarda Therapeutics, Inc.54