NL-OMON23800Not yet recruitingNot Applicable
Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach
Amsterdam UMC, location AMC0 sites12 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1)Subject must be at least 18 years of age.
- •2)Subject has a history of an IPAA for UC, all stages completed at least 6 months prior to day one of the start of the study.
- •3)Subject has chronic, recurrent and/or antibiotic refractory pouchitis, defined as a PDAI = 7 , with either
- •a)= 2 recurrent pouchitis episodes within 1 year prior to screening, necessitating treatment with antibiotics or other prescription, or;
- •b)Requiring maintenance antibiotic therapy for = 4 weeks to maintain clinical remission and a history of at least two attempts in the last 24 months to stop this therapy, resulting in a relapse of the pouchitis episodes.
- •4)Female subjects of childbearing potential, defined as biologically capable of having children and is sexually active, must agree to use a highly effective method of contraception throughout the study and for at least 4 weeks after the last dose of assigned treatment.
- •5)Female subjects of childbearing potential must have a negative pregnancy test prior to enrolment in the study.
- •6)Written informed consent must be obtained and documented.
Exclusion Criteria
- •1)Pouchitis due to surgery related conditions (such as an abscess, fistula, or sinus of the pouch).
- •2)Absence of a previous pelvic MRI to assess secondary causes of pouchitis.
- •3)Irritable pouch syndrome (symptoms without evidence of inflammation on endoscopy and histology).
- •4)Mechanical complications of the pouch (e.g. pouch stricture or pouch fistula).
- •5)Crohn’s disease of the pouch.
- •6)Patients with signs of severe systemic inflammation (at least two of the following symptoms: temperature > 38.5 °C, tachycardia > 100 bpm (after rehydration), systolic blood pressure < 100 mmHg).
- •7)Diverting ileostomy.
- •8)Chronic treatment for pouchitis with antibiotics. All antibiotics should be discontinued 4 weeks prior to baseline.
- •9)Positive stool sample for C. difficile, enteric pathogens, pathogenic ova or parasites at screening.
- •10)Subjects with clinically significant infections currently or within 6 months of baseline (e.g., those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), a history of any infection requiring antimicrobial therapy within 2 weeks of baseline, or a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
- •11)Active herpes zoster infection or history of disseminated zoster infection.
- •12)Evidence of an active infection during screening, or known history of chronic HBV, HCV, HIV infection, or if subject is immunodeficient.
- •13)Active or latent infection with Mycobacterium tuberculosis (TB), regardless of treatment history.
- •14)Subjects who have been vaccinated with live or attenuated vaccine within 6 weeks of baseline or scheduled to receive these vaccines during study period or within 6 weeks after last dose of study medication. Subjects with history of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), history of lymphoma, leukaemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
- •15)Subjects with a history of pulmonary embolism and/or deep venous thrombosis.
- •16)Subjects with malignancies or a history of malignancies, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
- •17)Subjects with a history of bowel surgery within 6 months prior to baseline.
- •18)Subjects with significant trauma or major surgery within 4 weeks of screening visit.
- •19)Subjects likely to require any type of surgery during the study period.
- •20)Subjects with the following laboratory values at screening:
- •a)Hemoglobin levels <5.5 mmol/L or hematocrit <30%.
- •b)An absolute white blood cell (WBC) count of <3.0 x 109/L (<3000/mm3) or absolute neutrophil count of <1.2 x 109/L (<1200/mm3), or an absolute lymphocyte count of <0.5 x 109/L (<500/mm3).
- •c)Thrombocytopenia, as defined by a platelet count <100 x 109/L (<100,000/mm3).
- •d)Subjects with estimated GFR <50 ml/min.
- •e)Subjects with total bilirubin, AST or ALT more than 1.5 times the upper limit of normal.
- •21)Subjects with evidence of or suspected liver disease i.e., liver injury due to methotrexate or primary sclerosing cholangitis.
- •22)Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including uncontrolled hyperchol
Investigators
Similar Trials
Completed
Phase 2
Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approachinflammation of the pouch reservoir10017969PouchitisNL-OMON52963Academisch Medisch Centrum13
Active, not recruiting
Phase 1
Treatment of refractory pouchitis with tofacitinibEUCTR2020-002695-12-NLAmsterdam UMC, location AMC12
Recruiting
Phase 4
A study to assess the efficacy of tofacitinib for the treatment of chronic pouchitis in adultsChronic pouchitisInflammatory and Immune System - Autoimmune diseasesOral and Gastrointestinal - Inflammatory bowel diseaseACTRN12621000173897Pfizer Australia120
Active, not recruiting
Phase 1
Research with the drug tofacitinib for patients with refractory celiac disease type IIRefractory celiac disease type IIEUCTR2018-001678-10-NLVU Medical Center5
Recruiting
Phase 2
Tofacitinib: salvage therapy for patients with RCDII - a pilot studygluten intolerancerefractory celiac disease type II1002532110017969NL-OMON52502Vrije Universiteit Medisch Centrum4