Reinisch 2011.
| Methods | Randomized, double blind, placebo‐controlled induction study in 94 centers across North America and Europe (ULTRA 1) | |
| Participants | Anti‐tumor necrosis factor (anti‐TNF)‐naïve patients with moderately to severely active UC (Mayo score > 6 points and endoscopic subscore > 2 points) despite treatment with corticosteroids and/or immunosuppressants 186 patients were randomized under the first protocol; after the protocol was amended there were 576 patients randomized |
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| Interventions | 1:1 treatment with subcutaneous adalimumab (160 mg at Week 0, 80 mg at Week 2, and 40 mg at Weeks 4 and 6) or placebo At the request of European regulatory authorities the protocol was amended ("Amendment 3") and a second induction group was added (80 mg at Week 0, 40 mg at Weeks 2, 4 and 6) |
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| Outcomes | HRQL was measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) and Mental and Physical Component Summary (MCS and PCS) scores of the Short Form 36 Health Survey (SF‐36) | |
| Notes | NCT00385736 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central randomization was performed using a scheme developed by the study sponsor Patients were randomized to adalimumab induction (ADA 160/80) or placebo (1:1 ratio, original protocol), or one of two adalimumab induction doses (ADA160/80 or ADA 80/40) or placebo (1:1:1 ratio, after study was amended) |
| Allocation concealment (selection bias) | Low risk | Centralized treatment allocation |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Patients, study site personnel, study investigators, and the study sponsor were blinded to treatment assignment throughout the study" The study drug and placebo were administered subcutaneously using pre‐filled syringes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described in methods |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Since Amendment 3 added a second adalimumab dose group, patients enrolled before the amendment were not included in the primary analysis (intention‐to‐treat) Patients randomized under the original protocol and all of the amendments were included in a second population, intention‐to‐treat‐ The safety population included all patients who received at least one dose of study drug or placebo |
| Selective reporting (reporting bias) | Low risk | Results of all patients and outcomes are reported in the text |
| Other bias | Low risk | No other apparent sources of bias |