Schreiber 2005.
| Methods | Randomized, double‐blind, placebo‐controlled, multicenter trial | |
| Participants | Adult patients (18‐75 years) with active Crohn's disease (CDAI: 220‐450) (N = 292) | |
| Interventions | Subcutaneous administration at week 0, 4, and 8 Group 1: Placebo (n = 73) Group 2: 100 mg of certolizumab pegol (n = 74) Group 3: 200 mg of certolizumab pegol (n = 72) Group 4: 400 mg of certolizumab pegol (n = 73) |
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| Outcomes | Primary outcome: Clinical response (> 100 points CDAI decrease) or remission (CDAI ≤ 150) at week 12 Secondary outcomes: 1. Clinical response or remission at weeks 2, 4, 6, 8, and 10 2. Remission at weeks 2, 4, 6, 8, 10, and 12 |
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| Notes | This study was conducted between February 2001 and March 2002 The follow‐up period was 20 weeks Funding source was Celltech R&D, Ltd (now UCB Inc). Additional support was provided by the German Federal Ministry for Education and Research Competence Network “Inflammatory Bowel Disease" Authors were from 5 countries: Germany, Belgium, Canada, UK, and Denmark Conflict of interest was reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Centralized randomization schemes with randomization code were used |
| Allocation concealment (selection bias) | Low risk | Centralized randomization schemes with randomization code were used |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The color or viscosity was different between Certolizumab pegol and placebo although patients received the treatment from independent healthcare workers |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Full blinding to the patients were not possible, and outcomes were based on a daily diary of their symptoms |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The number of patients with lost to follow‐up was only one in each group |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported |
| Other bias | Low risk | The study appears to be free of other sources of bias |