Controlled trial of antimycobacterial therapy in Crohn's disease. Clofazimine versus placebo

Dig Dis Sci. 1991 Apr;36(4):449-53. doi: 10.1007/BF01298873.


In order to study the effect of clofazimine, a powerful antimycobacterial and antiinflammatory agent, 49 patients with active Crohn's disease were randomized to either corticosteroids plus clofazimine 100 mg daily (N = 25) or to steroids and matching placebo (N = 24). A total of 28 patients (58%) went into disease remission (clofazimine 16, placebo 12; P = NS) with a fall in disease activity score from 10.5 +/- 4.4 to 3.3 +/- 3.5. Patients were treated for a further eight months with clofazimine or placebo and 18 of 28 maintained their remission and completed the study (clofazimine 12, placebo 6; P = NS). Side effects were minor and consisted of skin rash and increased pigmentation. Clofazimine as a solitary antimycobacterial agent appears ineffective in inducing remission in Crohn's disease but may have a role in either disease maintenance or combination chemotherapy.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Clofazimine / adverse effects
  • Clofazimine / therapeutic use*
  • Crohn Disease / drug therapy*
  • Double-Blind Method
  • Drug Evaluation
  • Female
  • Humans
  • Male
  • Middle Aged
  • Recurrence
  • Remission Induction


  • Clofazimine