ACTRN12621001098820
Recruiting
未知
Modulating Cardiovascular Risk in Inflammatory Bowel Disease Patients.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fiona Stanley Hospital
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For IBD Patients:
- •1\.A diagnosis of Ulcerative Colitis or Crohn’s Disease that has been diagnosed as per definition criteria no sooner than 12 weeks prior to baseline, and;
- •a.Requires the commencement of an anti\-TNFa agent.
- •b.And has failed no more than one prior biologic
- •c.Has a CDAI of 300 or Partial Mayo Score of 6, as per Medicare guidelines for re\-imbursement of biologic and a Faecal Calprotectin level of greater than 250 and/or a CRP
- •greater than 10\.
- •d.Is on a dose of less than 10mg of prednisolone and equivalent at baseline.
- •e.Is eligible by Medicare PBS criteria to commence a biologic.
- •For Healthy Controls:
- •1People who do not have IBD or another inflammatory disease (such as rheumatoid arthritis).
Exclusion Criteria
- •For IBD Patients:
- •1\.Contraindication to biologic therapy, such as an active, serious infection or malignancy.
- •2\.CDAI of less than 300 or Partial Mayo Score less than 6\.
- •3\.Fibro\-stenotic disease confirmed on endoscopy or imaging.
- •4\.Any live vaccinations prior to randomisation.
- •5\.Concurrent use of a second biologic or small molecule (e.g., JAK inhibitor).
- •6\.Prior failure of 2 of more biologics
- •7\.For ulcerative colitis patients, a diagnosis of acute severe ulcerative colitis (ASUC).
- •For All Patients (Healthy Controls and IBD):
- •1\.eGFR less than 30
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)Rheumatoid Arthritis and Systemic Lupus ErythematosusTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2014-005418-45-SEChristine Bengtsson
Completed
Phase 2
Inflammatory response and cardiac muscle damage markers in pediatric cardiac surgery: effect of two cardioplegia solutions Del Nido” and blood cardioplegia”Tetralogy of Fallot, Congenital Heart Diseases.Ventricular septal defect with pulmonary stenosis or atresia, dextroposition of aorta and hypertrophy of right ventricle.IRCT2016042627617N1Vice chancellor for research, ?Administrative building, Rajaei cardiovascular and medical center30
Completed
Not Applicable
Vascular Inflammation in Patients at Risk for Atherosclerotic Diseasearteriosclerosisatherosclerosis10047066NL-OMON36115Academisch Medisch Centrum80
Completed
Not Applicable
General Risk factors And iNflammatory Determinants in younger PAtients with copd: the GRANDPA studyNL-OMON52605Franciscus Ziekenhuis90
Completed
Not Applicable
Effect of ibuprofen + caffeine administration on the reduction of dental sensitivity from in-office bleachingRBR-48c9xtniversidade Estadual de Ponta Grossa - UEPG