Sandborn 2003.
| Methods | Randomised, double‐blind, placebo‐controlled, dose‐escalation trial comparing repifermin (keratinocyte growth factor‐2) to placebo (N = 88) | |
| Participants | Adult patients 18 years or older with mildly to moderately active UC (MCS 3‐10) despite treatment with oral 5‐ASA, corticosteroids, AZA and/or 6‐MP | |
| Interventions | Group 1: placebo (n = 28) Group 2: repifermin 1 lg/kg (n = 11) Group 3: repifermin 5 lg/kg (n = 11) Group 4: repifermin 1 lg/kg (n = 12) Group 5: repifermin 25 lg/kg (n = 12) Group 6: repifermin 50 lg/kg (n = 14) |
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| Outcomes | Primary outcomes (safety): adverse events at each visit; laboratory abnormalities; and the frequency of anti‐repifermin antibodies at baseline and week 6 (and at month 6 in patients positive for antirepifermin antibody at week 6) Primary outcome (efficacy): clinical remission Secondary outcomes (efficacy): (i) clinical response (improvement in MCS > 3 points); (ii) clinical response (improvement in MCS > 2 points) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The randomisation schedule was generated by a statistician at Human Genome Sciences Inc. (Rockville, MD, USA) |
| Allocation concealment (selection bias) | Low risk | Sealed randomisation envelopes were provided by the study statistician and maintained in the pharmacy or a secure drug storage facility at each site; treatment allocation was available to the study pharmacist or nurse responsible for preparing the drug, but not to other study personnel |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Repifermin and placebo had a similar clear and colourless appearance |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐outs were balanced across treatment groups with similar reasons for withdrawal |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | The study appears to be free of other sources of bias |