EUCTR2018-001678-10-NL进行中（未招募）1 期
Tofacitinib: salvage therapy for patients with RCDII - a pilot study - TOF-RCDII
VU Medical Center0 个研究点目标入组 5 人开始时间: 2019年2月20日最近更新:
适应症
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
- 5
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. Adult patients = 18 years old
- •2. Given informed consent
- •3. Diagnosis of RCDII
- •4. Total adherence to a glutenfree diet for at least 6 consecutive months prior to screening. Subjects must also agree to make no changes to their current GFD for the duration of study participation.
- •5. Anti-tissue transglutaminase (IgA and IgG) at screening < 2x the diagnostic level for celiac disease (weak positive or negative)
- •6. In case of female fertile patients: negative serum pregnancy test prior to study enrollment; adequate contraception, up to 4 weeks after final dose.
- •7. Laboratory values:
- •a) Total WBC > 0.75 x 10^9/L (i.e. > 750/mm3)
- •n) Hemoglobin > 5.5 mmol/L (i.e. 8.86 g/dL)
- •c) Absolute neutrophil count > 1 x 10^9 / L (i.e. > 1000 cells/mm3.)
- •d) Estimated eGFR > 30mL/min/1.73m2 using the Cockcroft-Gault equation.
- •e) Platelets > 50 x 109/L (i.e. 50000/mm3)
- •8. PET/CT-scan without signs of abnormalities suggestive for EATL within 3 months.
- •9. Willingness and ability to comply with study procedures.
- •10. Willingness to return for all scheduled follow-up visits.
- •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 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Diagnosis of RCDI, EATL
- •2. Presence of any of the following diagnosis:
- •a) Active acute infections, which require systemic treatments (specific attention for treatment with ketoconazol or fluconazole (as well CYP3A4 metabolizers).
- •b) Severe infection prior to screening
- •c) Active tuberculosis (TBC) (as confirmed in PET/CT-scan; chest radiography)
- •d) Untreated or inadequately treated latent TB (as confirmed with a positive IGRA test (QuantiFERON-TB Gold Plus test)).
- •- NB. Subjects are permitted to enroll in study after = 4 months treatment with rifampicine)
- •e) History within 3 years of opportunistic infections typical of those seen in immunocomprised patients, such as systemic candida infection.
- •f) Severe liver insufficiency (Child Pugh Score 10-15)
- •3. Positive Hep B, Hep C or HIV test results at the time of screening.
- •4. Vaccination with live, attenuated vaccines (such as varicella zoster vaccine, yellow fever, oral typhoid vaccine) within 2 weeks before start of tofacitinib.
- •5. History of significant immune suppression:
- •a) BMT therapy less than 6 months prior to baseline
- •b) Potent systemic immune suppressants (e.g., azathioprine, within specified time periods per drug type) prior to baseline.
- •6. Subjects receiving moderate/potent CYP3A inducers or inhibitors in the specified time periods prior to the first dose of study drug:
- •- Moderate/potent CYP3A inducers, within 28 days of 5 half-lives, whichever is longer, prior to first dose of study drug;
- •- Moderate/potent CYP3A inhibitors, within 7 days or 5 half-lives, whichever is longer, prior to first dose of study drug.
- •i. NB.Topical (including skin or mucous membranes) application of antimicriobial and antifungal medications is permitted.
- •7. Screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results.
- •8. History or presence of clinically significant disease that in the opinion of the investigator would confound the subject’s participation and follow-up in the clinical trial or put the subject at unnecessary risk (e.g. uncontrolled cardiac diseases, uncontrolled/chronic pulmonary, renal, endocrine, hematological, gastrointestinal, immunologic, dermatological, neurological or psychiatric dysfunction).
- •9. History of drug or alcohol abuse that would interfere with the ability to comply with the study protocol.
- •10. History of clinically significant hypersensitivity to the study drug or to any of the excipients
- •11. Females who are pregnant, becoming pregnant or are currently breastfeeding.
- •12. Participation in any other investigational drug study in the past 30 days/5 half-lives.
- •13. Any additional reason which would endanger safety of the subject for participation in this study, in the opinion of the investigator.
研究者
相似试验
招募中
2 期
Tofacitinib: salvage therapy for patients with RCDII - a pilot studygluten intolerancerefractory celiac disease type II1002532110017969NL-OMON52502Vrije Universiteit Medisch Centrum4
招募中
不适用
Research with the drug tofacitinib for patients with refractory celiac disease type II<p>Refractory Celiac Disease type IIRCDIIRefractaire Coeliakie type II</p>NL-OMON25125Amsterdam UMC, location VU University Medical Center5
已完成
2 期
Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approachinflammation of the pouch reservoir10017969PouchitisNL-OMON52963Academisch Medisch Centrum13
进行中（未招募）
1 期
Treatment of refractory pouchitis with tofacitinibEUCTR2020-002695-12-NLAmsterdam UMC, location AMC12
尚未招募
不适用
Treatment of chronic, recurrent and/or antibiotic refractory pouchitis with tofacitinibNL-OMON23800Amsterdam UMC, location AMC12