Other Considerations

The use of concurrent medications is a significant challenge when conducting clinical trials in IBD. The question of what medications to allow and what to exclude is encountered almost universally, as it is extremely unlikely that any patient eligible for entry onto a clinical trial will not already be taking some medication. For example, the concomitant use of immunosuppressants can reduce the apparent immunogenicity of a biological therapy, thereby potentially overstating its safety profile, or in the context of a 'placebo' group, the magnitude of the 'placebo' effect may be enhanced. Still, there is no answer that is universally acceptable concerning concurrent medications and some issues will be specific to certain types of trial. In literature, allowable concurrent mediations have ranged from 5-aminosalicyclic acid (5-ASAs) only, to any medication as long as it is stable in terms of dose regimen at the time of entry into the trial and not increased during the study.

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