Feagan 2005.
Methods | Randomised, double‐blind, placebo‐controlled, 8 week induction trial involving 20 centers. Computer‐generated block randomization schedule. | |
Participants | 181 adult subjects (98M/83F) with moderately active UC (ulcerative colitis clinical score 5 to 9, with either stool frequency or rectal bleeding score at least 1, and modified Baron score of at least 2, with disease minimum 25cm from anal verge). Exclusion criteria: oral corticosteroids within 4 weeks, topical mesalamine or corticosteroids within 1 week, immunosuppressive therapy within 3 months, severe disease, abnormal WBC, platelet, AST, ALT, or creatinine, positive stool test for infectious pathogens, proteinuria. | |
Interventions | MLN02 0.5mg/kg (n=58), MLN02 2mg/kg (n=60), or placebo (n=63) intravenous infusion on day 1 and day 29. | |
Outcomes | Primary outcome measure: Clinical remission at week 6, defined as an ulcerative colitis clinical score of 0 or 1 and a modified Baron score of 0 or 1 with no evidence of rectal bleeding. Secondary outcome measures: Changes in ulcerative colitis clinical scores, Riley scores, and IBDQ scores. Proportion of subjects with clinical response (defined as a decrease of 3 or more on the Mayo score) at week 4 and 6, endoscopic remission (defined as a modified Baron score of 0) at week 4 and 6, endoscopic response (defined as a 2 or more grade improvement in the modified Baron score) at week 4 and 6. Patients were evaluated at baseline and one, two, four, and six weeks after randomization. Sigmoidoscopy was performed at weeks 0, 4 and 6. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "according to a computer generated schedule" Comment: The sequence was randomised |
Allocation concealment (selection bias) | Low risk | Centralized randomization |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Neither the investigators nor the patients were aware of the treatment assignment. The placebo was identical in appearance to MLN02." Comment: Blinding of assessors and participants was adequate. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates in the groups were 2%, 8% and 5% for the MLN02 0.5mg/kg, MLN02 2.0mg/kg and placebo groups. Quote: "No important differences were observed among the three groups in the reasons for withdrawal." |
Selective reporting (reporting bias) | Low risk | All primary and secondary outcomes were reported. |
Other bias | Low risk | No other apparent sources of bias. |