EUCTR2019-003662-40-DE进行中（未招募）1 期
Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED
niversitätsklinikum Erlangen0 个研究点目标入组 82 人开始时间: 2019年10月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
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
- •1. Age: 18-80 years
- •2. Male or female
- •3. Subject is mentally able to understand the nature and content of the clinical trial and to follow the instructions of the study staff
- •4. Existence of a written informed consent
- •5. Diagnosis of chronic inflammatory bowel disease with indication for initial treatment with adalimumab in subjects with moderate to high grade disease activity and clinically insufficient response to or contraindication for systematic therapy with corticosteroids and/ or immunosuppressants, as defined below:
- •Current diagnosis of moderate to severe, ulcerative colitis with a total Mayo score of =6 (endoscopic subscore of =2) that has been confirmed in accordance with the current guidelines of the DGVS and ECCO and has been in existence for at least 3 months.
- •Current diagnosis of a moderate to severe active M. Crohn with a Harvey-Bradshaw index of =8 months, which has been confirmed in accordance with the current guidelines of the DGVS and ECCO and has been in existence for at least 3 months.
- •insufficient response or intolerance to conventional therapy (including oral 5-ASA supplements, oral glucocorticoids, azathiopurine, 6-mercaptopurine or methothrexate)
- •6. If concomitant therapy is necessary, then under the following conditions:
- •a. Systemic therapy with glucocorticoids: stable dosage for at least two weeks before screening
- •b. MMX budesonide (9 mg/day), stable osage for 4 weeks before screening
- •c. 5-aminosalicylates: stable dosage for at least two weeks and initiated for at least 8 weeks before screening
- •d. Immunosuppressants (except ciclosporin A and tacrolimus): therapy for at least three months and stable dosage for at least four weeks before screening
- •7. Existence of endoscopic diagnostics taking into account the individual infestation pattern of the patient. The last endoscopic findings may have been collected no more than 12 weeks before the screening.
- •8. Female participants of child bearing potential must also meet at least one of the following criteria:
- •- menopause (at least 12 months of natural amenorrhea or six months of amenorrhea with serum-FSH >40mU/ml) or
- •- condition after ovarectomy or hysterectomy on both sides for at least six weeks before the screening date (visit 1, day -7-6 days) or
- •- Regular, correct and reliable use of a method of contraception with a failure rate of 1% per year (e.g. implants, depot syringes, intrauterine pessar, hormonal spirals) or
- •- partner's vasectomy.
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Known contraindications for adalimumab therapy:
- •- Known hypersensitivity to any of the ingredients of the investigational medicinal product or to medicinal products with a similar chemical structure
- •- Moderate to severe heart failure (NYHA III/IV).
- •- Active tuberculosis.
- •- Severe acute infection including sepsis.
- •- Acute opportunistic infections including invasive fungal infections.
- •2. Acute or chronic infection with hepatitis B
- •3. Known demyelinating diseases of the central and peripheral nervous system (e.g. multiple sclerosis, Guillain-Barré syndrome)
- •4. Malignant disease (active malignancy under ongoing oncological therapy or a recent malignancy with moderate to high risk of recurrence within the last 5 years prior to screening)
- •5. The existence of another serious disease which, at the discretion of the investigator would result in a disproportionate risk to the patient concerned
- •6. Pregnancy and lactation
- •7. Administration of other anti-TNF-Ak therapies, ustekinumab, vedolizumab or tofacitinib within the last 4 weeks prior to study inclusion
- •8. Administration of ciclosporin A or tacrolimus within the last 8 weeks prior to study inclusion in a non-stable dose
- •9. Therapy with Anakinra or Abatacept
- •10. Planned surgical intervention during the study period such as colectomy, installation of an ileo-anal pouche, an ileorectostomy or an ileostoma
- •11. Persons who are dependent or employed by the sponsor or investigator.
- •12. Planned longer stay outside the region, which prevents compliance with the visit plan.
- •13. Participation in another clinical trial or administration of an unauthorised active substance within the last 4 weeks prior to the screening date.
研究者
相似试验
进行中（未招募）
不适用
Prospective, single-arm, single-center, open-label trial to investigate the tolerability of NT 201 and quality of life of patients in the treatment of blepharospasm with shortened injection intervalsBlepharospasmMedDRA version: 9.1Level: LLTClassification code 10005159Term: BlepharospasmEUCTR2007-000697-23-DEMerz Pharmaceuticals GmbH58
进行中（未招募）
不适用
Prospective, single-arm, multi-center, open-label study to investigate the efficacy and tolerability of the once daily [OD] memantine treatmentDementia of Alzheimer’s Type [DAT] in patients with Mini Mental State Examination [MMSE] < 20MedDRA version: 10.0Level: LLTClassification code 10012271Term: <Manually entered code. Term in E.1.1>EUCTR2006-003616-21-ATMerz Pharmaceuticals GmbH119
进行中（未招募）
不适用
Prospective, single-arm, multi-center, open-label study to investigate the efficacy and tolerability of the once daily [OD] memantine treatmentEUCTR2006-003616-21-DEMerz Pharmaceuticals GmbH119
进行中（未招募）
不适用
Prospective, single-arm, multi-center, open-label study to investigate the potential to reduce concomitant antipsychotics use in subjects with moderate dementia of Alzheimer’s type [DAT] treated with memantine - MemAPDementia of Alzheimer’s Type [DAT] in subjects with Mini Mental State Examination [MMSE] score 10-19 and Global Deterioration Scale [GDS] score 3-5 and antipsychotics medication during the last 3 months (at least intake at 5 days/week)MedDRA version: 10.1Level: LLTClassification code 10012271Term: <Manually entered code. Term in E.1.1>EUCTR2007-004489-41-DEMerz Pharmaceuticals GmbH
进行中（未招募）
1 期
An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsEUCTR2018-002821-45-DEActelion Pharmaceuticals Ltd111