Methotrexate in chronic active Crohn's disease: a double-blind, randomized, Israeli multicenter trial

Am J Gastroenterol. 1997 Dec;92(12):2203-9.


Background: At present only one large controlled study has indicated that parenteral methotrexate may be effective in chronic active Crohn's disease (CD).

Aim: To evaluate the effectiveness of oral methotrexate in chronic steroid-dependent CD.

Patients: Patients with active CD, who have received steroids and/or immunosuppressives for at least 4 months during the preceding 12 months and with a current Harvey-Bradshaw index of > or = 7 were studied.

Methods: Methotrexate (12.5 mg weekly) or 6-mercaptopurine (50 mg daily), or placebo were given during the 9 months of the trial in addition to steroids and 5-aminosalicylic acid as clinically indicated.

Results: Eighty-four patients were included (methotrexate, 26 patients; 6-mercaptopurine, 32 patients; placebo, 26 patients). The proportion of patients entering first remission as well as the proportions of patients relapsing after first remission were not significantly different between the groups. The mean Harvey-Bradshaw index and the mean monthly steroid dose were also similar. However, when each patient was evaluated as his or her own control, the reduction in steroid dose, the general well being, and the reduction in abdominal pain were significantly better in the methotrexate treated patients.

Conclusions: Methotrexate at a weekly oral dose of 12.5 mg was found to be moderately better than 6-mercaptopurine and placebo in patients with chronic active CD.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Pain / prevention & control
  • Administration, Oral
  • Adolescent
  • Adrenal Cortex Hormones / administration & dosage
  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / therapeutic use*
  • Chronic Disease
  • Crohn Disease / drug therapy*
  • Double-Blind Method
  • Evaluation Studies as Topic
  • Female
  • Follow-Up Studies
  • Health Status
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / therapeutic use
  • Israel
  • Male
  • Mercaptopurine / administration & dosage
  • Mercaptopurine / therapeutic use
  • Mesalamine / administration & dosage
  • Mesalamine / therapeutic use
  • Methotrexate / administration & dosage
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Placebos
  • Recurrence
  • Remission Induction
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Anti-Inflammatory Agents, Non-Steroidal
  • Antirheumatic Agents
  • Immunosuppressive Agents
  • Placebos
  • Mesalamine
  • Mercaptopurine
  • Methotrexate