Crohn's disease (CD)
Conditions
Interventions
LDN induction therapy 4.5 mg once daily or placebo orally for 12 weeks followed by open label maintenance therapy of 4.5 mg LDN once daily during one year.
Sponsors
ZonMW
Eligibility
Inclusion criteria
Inclusion criteria: - Age 18 or older; must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures. - Diagnosis of Crohn’s disease =3 months before screening. - Objective evidence of inflammation at baseline as defined by endoscopy with mucosal ulcers in the ileum or colon or both, and a SES-CD score of 3-15. - Concurrent therapies with stable doses of azathioprine, mercaptopurine, MTX or steroids (prednisolone =30 mg/dl or budesonide =9 mg per day) are permitted. Tapering of corticosteroids is mandatory.
Exclusion criteria
Exclusion criteria: - Current use of i.v. corticosteroids. - Imminent need for in-hospital treatment. - Pregnancy or lactation. - Previous or current treatment with investigational drug; current or past treatment within 6 months prior to randomization with a biological agent. - Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp. - Other significant illnesses that may interfere with the study, stricture causing obstructive symptoms, or fistulising disease complicated by infection, - Opiates use or drugs and/or alcohol abuse. - Concomitant use of TNA alpha antagonist, Integrin antagonist, Interleukin antagonist, Cyclosporine, thalidomide, tacrolimus and any JAK inhibitors. Wash out period mandatory.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic remission at week 12 defined as SES-CD =4 and ulcerated surface subscore =1 in all five segments | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patient in steroid free clinical remission - Response defined by a decrease in HBI of =3 points compared to baseline and endoscopic response defined as a reduction of SES-CD score by =50% vs baseline at week 12 - Changes in laboratory measures of inflammation (CRP, fecal calprotectin) from baseline at week 12,24 and 52 - Adverse events at every visit - Response at week 24 and 52 (HBI) - Endoscopic remission and response at week 52 - Quality of life, fatigue, anxiety, depression, sleepdisturbance, healthcare costs, workdisability | — |
Contacts
Public ContactProf. dr. C.J. vd Woude
Erasmus MC
Outcome results
None listed