NL-OMON52502招募中2 期
Tofacitinib: salvage therapy for patients with RCDII - a pilot study - TOF-RCDII
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult patients >= 18 years old
- •2. Given informed consent
- •3. Diagnosis of RCDII
- •4. Total adherence to a gluten-free diet (GFD) 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: adequate contraception, up to 4 weeks
- •after final dose.
- •7. Laboratory values:
- •a) Total WBC > 0.75 x 109/L (i.e. > 750/mm3)
- •b) Hemoglobin > 5.5 mmol/L (i.e. 8.86 g/dL)
- •c) Absolute neutrophil count > 1 x 109 / 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
- •9. Willingness and ability to comply with study procedures.
- •10. Willingness to return for all scheduled follow-up visits.
排除标准
- •1. Diagnosis of RCDI, EATL
- •2. Presence of any of the following diagnosis:
- •a) Severe infection prior to screening (e.g. those requiring hospitalization of
- •parenteral antimicrobial therapy or opportunistic infections. Specific
- •attention for treatment with ketoconazol or fluconazole (as well CYP3A4
- •metabolizers)).
- •b) Active tuberculosis (TBC)
- •c) Untreated or inadequately treated latent TBC
- •d) History within 3 years of opportunistic infections typical of those seen in
- •immunocomprised patients, such as systemic candida infection; disseminated
- •herpes zoster.
- •e) Severe liver insufficiency (Child Pugh Score 10-15).
- •3. Positive Hep B or Hep C test results at the time of screening.
- •4. Vaccination with live, attenuated vaccines (such as varicella zoster
- •vaccine, yellow fever or 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 immunosuppressant) 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.
- •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).
- •i. Specific attention for risk factors for pulmonary embolism, such as:
- •use of hormonal contraception, heart failure, previous venous thromboembolism,
- •hereditary coagulation disorder, malignancy, patients who get major surgery.
- •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
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