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. 2015 Sep 14;2015(9):CD006790. doi: 10.1002/14651858.CD006790.pub3

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)
Interventions Group 1: IFNβ‐1a 30 μg IM twice a week for 12 weeks
Group 2: placebo IM twice per week for 12 weeks
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
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