14 CLINICAL STUDIES
14.1 Crohn's Disease
The efficacy and safety of CIMZIA were assessed in two double-blind, randomized, placebo-controlled studies in patients aged 18 years and older with moderately to severely active Crohn's disease, as defined by a Crohn's Disease Activity Index (CDAI1) of 220 to 450 points, inclusive. CIMZIA was administered subcutaneously at a dose of 400 mg in both studies. Stable concomitant medications for Crohn's disease were permitted.
Study CD1
Study CD1 was a randomized placebo-controlled study in 662 patients with active Crohn's disease. CIMZIA or placebo was administered at Weeks 0, 2, and 4 and then every four weeks to Week 24. Assessments were done at Weeks 6 and 26. Clinical response was defined as at least a 100-point reduction in CDAI score compared to baseline, and clinical remission was defined as an absolute CDAI score of 150 points or lower.
The results for Study CD1 are provided in Table 2. At Week 6, the proportion of clinical responders was statistically significantly greater for CIMZIA-treated patients compared to controls. The difference in clinical remission rates was not statistically significant at Week 6. The difference in the proportion of patients who were in clinical response at both Weeks 6 and 26 was also statistically significant, demonstrating maintenance of clinical response.
Table 2 Study CD1 – Clinical Response and Remission, Overall Study Population Timepoint % Response or Remission (95% CI)
Placebo
(N = 328) CIMZIA 400 mg
(N = 331)
*
Clinical response is defined as decrease in CDAI of at least 100 points, and clinical remission is defined as CDAI ≤ 150 points
†
p-value < 0.05 logistic regression test
Week 6
Clinical Response* 27% (22%, 32%) 35% (30%, 40%)†
Clinical Remission* 17% (13%, 22%) 22% (17%, 26%)
Week 26
Clinical Response 27% (22%, 31%) 37% (32%, 42%)†
Clinical Remission 18% (14%, 22%) 29% (25%, 34%)†
Both Weeks 6 & 26 
Clinical Response 16% (12%, 20%) 23% (18%, 28%)†
Clinical Remission 10% (7%, 13%) 14% (11%, 18%)
Study CD2
Study CD2 was a randomized treatment-withdrawal study in patients with active Crohn's disease. All patients who entered the study were dosed initially with CIMZIA 400 mg at Weeks 0, 2, and 4 and then assessed for clinical response at Week 6 (as defined by at least a 100-point reduction in CDAI score). At Week 6, a group of 428 clinical responders was randomized to receive either CIMZIA 400 mg or placebo, every four weeks starting at Week 8, as maintenance therapy through Week 24. Non-responders at Week 6 were withdrawn from the study. Final eva luation was based on the CDAI score at Week 26. Patients who withdrew or who received rescue therapy were considered not to be in clinical response. Three randomized responders received no study injections, and were excluded from the ITT analysis.
The results for clinical response and remission are shown in Table 3. At Week 26, a statistically significantly greater proportion of Week 6 responders were in clinical response and in clinical remission in the CIMZIA-treated group compared to the group treated w