Sandborn 2007.
| Study characteristics | ||
| Methods | Multicenter randomized, double‐blind, placebo‐controlled trial This study was conducted at 53 centres in Europe, the United States and Canada between August 2002 and January 2005 Intention‐to‐treat analysis performed 56‐week trial All participants had previously completed the CLASSIC I trial prior to enrolling in this study. Only those who achieved clinical remission (CDAI < 150) after induction were eligible for enrolment in this study |
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| Participants | Adults aged 18 ‐ 75 with CD who achieved remission following 4 week induction protocol in CLASSIC I were eligible for inclusion. Participants were in remission (CDAI < 150) at time of randomization (N = 55) | |
| Interventions | Participants who responded to both induction therapy and open‐label doses (adalimumab 40 mg sc) at week 0 and 2 were randomized (1:1:1) into 3 groups: adalimumab 40 mg bi‐weekly (n = 19); adalimumab 40 mg weekly (n = 18); and placebo (n = 18) | |
| Outcomes | Primary end point was the proportion of participants in clinical remission (CDAI < 150) at week 56 Secondary end points included the percentages of participants in remission at week 24; 70‐point and 100‐point clinical responses at weeks 24 and 56; changes in IBDQ total score from baseline to weeks 24 and 56; percentages of participants who completely discontinued steroids without loss of remission at weeks 24 and 56 | |
| Notes | This study was funded by a research grant from Abbott Laboratories, Abbott Park, Illinois, USA. Author conflicts of interest were not reported in the manuscript | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central randomization was performed |
| Allocation concealment (selection bias) | Low risk | Pharmacist or designate was responsible for dispensing study drug |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and investigators |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objective measurements performed to assess end points (CDAI, IBDQ) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 participants withdrew from the placebo group; 1 due to adverse events, 3 withdrew consent and 1 failed to respond. 3 participants withdrew from the adalimumab bi‐weekly group; 1 due to adverse events, 1 withdrew consent and 1 was lost to follow‐up. 2 participants withdrew from the adalimumab weekly group; 1 due to adverse events and 1 withdrew consent |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other sources of bias |