EUCTR2011-001342-15-LT进行中（未招募）不适用
A 36-week open-label extension study of CACZ885H2361 on the safety and tolerability of canakinumab 150 mg s.c. pre-filled syringe (PFS) in treating acute gouty arthritis flares in frequently flaring patients - H2361E1
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
- 350
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
- •- Signed written informed consent before any study procedure is performed.
- •- Completion of the core study CACZ885H2361 up to and including the End of Study visit (Visit 8) having fulfilled the entry criteria, completed the study and with acceptable compliance (no protocol deviations).
- •- Patients remain with unchanged significant clinical medical history from entry to completion of the core study CACZ885H2361.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- If entering in this extension study would be considered inappropriate by the treating physician.
- •- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
- •- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partner has been sterilized by vasectomy or other means. Women are
- •considered post menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor
- •symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal
- •litigation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child
- •bearing potential, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
- •a. Use of oral, injected or implanted hormonal methods of contraception
- •b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- •c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
- •d. Total abstinence or male/female sterilization
- •- No additional exclusions may be applied by the investigator, in order to ensure that the study
- •population will be representative of all eligible patients.
研究者
相似试验
进行中（未招募）
不适用
ong-term safety and tolerability of Canakinumab Prefilled Syringes in frequently flaring acute gouty arthritis patientsEvaluate the long-term safety, tolerability and immunogenicity of canakinumab 150 mg s.c. administered as pre-filled syringe (PFS).MedDRA version: 14.0Level: LLTClassification code 10018628Term: Gout acuteSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-001342-15-HUovartis Services AG350
进行中（未招募）
不适用
ong-term safety and tolerability of Canakinumab Prefilled Syringes in frequently flaring acute gouty arthritis patientsEvaluate the long-term safety, tolerability and immunogenicity of canakinumab 150 mg s.c. administered as pre-filled syringe (PFS).MedDRA version: 14.0Level: LLTClassification code 10018628Term: Gout acuteSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-001342-15-DEovartis Services AG360
进行中（未招募）
不适用
An open-label extension study of CACZ885H2356E1 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective - H2356E2Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffectiveMedDRA version: 12.1Level: LLTClassification code 10018627Term: GoutEUCTR2010-019559-23-SEovartis Pharma Services AG200
进行中（未招募）
不适用
An open-label extension study of CACZ885H2356E1 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective - H2356E2Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffectiveMedDRA version: 12.1Level: LLTClassification code 10018627Term: GoutEUCTR2010-019559-23-DEovartis Pharma Services AG200
进行中（未招募）
不适用
/AEUCTR2010-019559-23-LVovartis Pharma Services AG200