{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T10:03:59Z","timestamp":1791540239208,"version":"4.3.4"},"reference-count":33,"publisher":"BMJ","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gut"],"published-print":{"date-parts":[[2007,9]]},"abstract":"<jats:p>\n                    <jats:bold>Background:<\/jats:bold>\n                    Adalimumab induced clinical remission after four weeks in patients with active Crohn\u2019s disease in the CLASSIC I trial.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Objective:<\/jats:bold>\n                    To evaluate long term efficacy and safety of adalimumab maintenance therapy in Crohn\u2019s disease in a follow-on randomised controlled trial (CLASSIC II).\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Methods:<\/jats:bold>\n                    In the preceding CLASSIC I trial, 299 patients with moderate to severe Crohn\u2019s disease naive to tumour necrosis factor antagonists received induction therapy with adalimumab 40 mg\/20 mg, 80 mg\/40 mg, or 160 mg\/80 mg, or placebo, at weeks 0 and 2. In all, 276 patients from CLASSIC I enrolled in CLASSIC II and received open-label adalimumab 40 mg at weeks 0 (week 4 of CLASSIC I) and 2; 55 patients in remission at both weeks 0 and 4 were re-randomised to adalimumab 40 mg every other week, 40 mg weekly, or placebo for 56 weeks. Patients not in remission at both weeks 0 and 4 were enrolled in an open-label arm and received adalimumab 40 mg every other week. With non-response or flare, these patients could have their dosages increased to 40 mg weekly. Patients in the randomised arm with continued non-response or disease flare could switch to open-label adalimumab 40 mg every other week and again to 40 mg weekly. The primary end point was maintenance of remission (CDAI &lt;150) in randomised patients through week 56.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Results:<\/jats:bold>\n                    Of 55 patients randomised at week 4, 79% who received adalimumab 40 mg every other week and 83% who received 40 mg weekly were in remission at week 56,\n                    <jats:italic>v<\/jats:italic>\n                    44% for placebo (p&lt;0.05). In all, 204 patients entered the open-label arm. Of these, 93 (46%) were in clinical remission at week 56. Adalimumab was generally well-tolerated in all patients.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Conclusions:<\/jats:bold>\n                    Adalimumab induced and maintained clinical remission for up to 56 weeks in patients with moderate to severe Crohn\u2019s disease naive to anti-TNF treatment.\n                  <\/jats:p>","DOI":"10.1136\/gut.2006.106781","type":"journal-article","created":{"date-parts":[[2007,2,13]],"date-time":"2007-02-13T21:49:04Z","timestamp":1171403344000},"page":"1232-1239","source":"Crossref","is-referenced-by-count":850,"title":["Adalimumab for maintenance treatment of Crohn\u2019s disease: results of the CLASSIC II trial"],"prefix":"10.1136","volume":"56","author":[{"given":"W J","family":"Sandborn","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S 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