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

Ran Oren, Menachem Moshkowitz, Shmuel Odes, Stuart Becker, Daniel Keter, Itamar Pomeranz, Chaim Shirin, Ilan Reisfeld, Efrat Broide, Alexandra Lavy, Alexander Fich, Rami Eliakim, Julian Patz, Yael Villa, Nadir Arber, Tuvia Gilat*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Background: At present only one large controlled study has indicated that patenteral 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 ≥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.

Original languageEnglish
Pages (from-to)2203-2209
Number of pages7
JournalAmerican Journal of Gastroenterology
Issue number12 SUPPL.
StatePublished - Dec 1997


Dive into the research topics of 'Methotrexate in chronic active Crohn's disease: A double-blind, randomized, Israeli multicenter trial'. Together they form a unique fingerprint.

Cite this