Mannon 2010.
Methods | Double‐blind, multicenter, randomised, placebo‐controlled trial (Biogen Trial) | |
Participants | 123 patients (18‐65 year old) with moderate to severe UC (modified Mayo Score 6‐13) Group 1: n=62, M:F = 43:19, median age = 41.1 yrs (21‐64); Group 2: n=61, M:F = 35:26, median age = 41.0 yrs (20‐65) |
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Interventions | Group 1: IFNβ‐1a 30 μg IM twice a week for 12 weeks Group 2: placebo IM twice per week for 12 weeks |
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Outcomes | Primary endpoint: clinical response at week 8, defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore of 0 or 1 Secondary endpoints: safety and tolerability of IFNb and the percentage of subjects with a decrease in the Short Clinical Activity Index (SCCAI) score of ≥3 points at week 8 |
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Notes | It is a conference abstract publication, efforts to locate the full journal article in the literature and to contact the trial lead author were unsuccessful | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not described in the publication |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double blind (subject, caregiver) ‐ based on information published on clinicaltrials.gov; trial ID: NCT00616434 |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 123 enrolled patients were included in the intention to treat (ITT) population, 61 in placebo and 62 in IFNβ. 6/62 (9.68%) patients in the IFNβ‐1a 30 μg treatment group and 8/61 (13.1%) patients in the placebo group did not complete the study |
Selective reporting (reporting bias) | Low risk | Pre‐defined outcomes were reported |
Other bias | Low risk | No other issues were identified |