Active Crohn's Disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 18 year or older; 2) Active Crohn’s Disease Activity (CDAI) Score >200 to 450; 3) The diagnosis of IBD and distribution of disease will have been confirmed during the course of their diagnostic investigations including endoscopic and histological parameters compatible with this diagnosis; 4) The participant must be able to fully understand patient information sheet and sign an informed consent form; 5) Patients must be on a stable dose of the following medications prior to inclusion. Patients will be required to be established on a stable dose of corticosteroids of 20mg or less daily for at least 2 weeks prior to enrolment. Patients will also be required to be on a stable doses of immunosuppressants or 5-aminosalicylates as follows: 5-aminosalicylates (=4 weeks) and thiopurines (=8 weeks). No other biological agents must have been administered within 8 weeks of enrolment. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients unable to give informed written consent; 2) Co-existence of any other chronic inflammatory condition e.g. rheumatoid arthritis; 3) Failure to meet above inclusion criteria medication regimen as described in the inclusion criteria. 4) Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity (e.g. Primary hyperparathyroidism); 5) Diagnosis of any of the followwing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy,active TB, sarcoidosis or lymphoma or other granbulomatous disease; 6) Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab); 7) Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L; 8) Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to Infliximab in the induction of remission in active Crohn's Disease.;Secondary Objective: Demonstration of the ability of vitamin D to improve symptoms and inflammatory markers in active Crohn's Disease.;Primary end point(s): Primary Efficacy Endpoint: Clinical Remission at end of week 4 based on CDAI score <150 | — |
Countries
United Kingdom
Outcome results
None listed