EUCTR2018-003162-13-IT进行中（未招募）1 期
A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •Age = 18 years
- •Signed and dated informed consent
- •RA diagnosis according to ACR/EULAR 2010 criteria
- •Disease onset within 3 years
- •Tofacitinib oral therapy required due to synthetic or biologic DMARD
- •failure/intolerance according to EULAR recommendations
- •Glucocorticoid daily dose stable for at least 3 months and = 5 mg/day of
- •prednisolone equivalent.
- •Unregarding ACPA status (both positive and negative included).
- •Wash out from previous biologic agent = 3 half lives of the biologic agent and at
- •least 3 months.
- •women of childbearing age must have a negative urine pregnancy test within 7 days
- •before beginning treatment and they will be informed of the need of an efficacy
- •contraceptive method during the administration and after 4 weeks from the last dose of
- •tofacitinib
- •patients must be negative to screening exam for latent infections ( HIV, HCV, HBV,
- •quantiferon, chest x-rays)
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Other rheumatic diagnosis other than RA
- •Bone diseases other than osteoporosis
- •Severe liver or kidney disease
- •Not-controlled endocrine disease
- •Contraindication to tofacitinib (concomitant recurrent or chronic infections,
- •tumor in the previous 5 years)
- •Previous treatment with other biologic agents within 3 months or 3 half lives of
- •the last one
- •Concomitant (or before 12 months, except for zoledronate that is before 24
- •months) treatment with bisphosphonate, strontium ranelate, teriparatide, selective
- •estrogen receptor modulators (SERM) or denosumab.
- •Intra-articular injections at MCPs or MTPs in the 3 months before.
- •Pregnancy or breast feeding status
- •Prisoners or subjects who are compulsory detained
研究者
相似试验
招募中
不适用
effect of biochemical markers of bone turnover for treating and predicting fracture risk risk of metabolic bone diseaseosteoporosisJPRN-UMIN000008979Osaka City University Graduate School of Medicine400
招募中
不适用
effect of biochemical markers of bone turnover for predicting fracture risk and changes of the bone mineral density in a long-term cohort studyosteopeniaJPRN-UMIN000008977Osaka City University Graduate School of Medicine300
进行中（未招募）
1 期
Bone turnover markers as predictors of treatment break outcomeMedDRA version: 19.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859OsteoporosisEUCTR2016-003110-27-DKBente Lomholt Langdahl, Dept. of Endocrinology and Internal Medicine, Aarhus University Hospital140
已完成
不适用
Measurement of biochemical markers of bone turnover in patients with bilateral sagittal split osteotomybone specific markers in urine and serum10005959NL-OMON36318niversitair Medisch Centrum Groningen20
招募中
不适用
examination of bone turnover markers in spinal fusion surgerydegenerative lumbar spinal diseasesJPRN-UMIN000036285Hakodate Central General Hospital100