Table 1.
Primary and secondary aims of TARGET-IBD
| Primary aims | • Evaluate IBD treatment regimens being used in clinical practice |
| • Examine outcomes of biosimilar use, including nonmedical switches from originator biologic, reverse switches back to the originator, and cross-switches between biosimilars | |
| • Examine populations underrepresented in phase III clinical trials | |
| • Evaluate optimal duration, timing, sequence, and combination of IBD therapy(ies) to achieve clinical response and clinical remission | |
| • Evaluate endoscopic outcomes | |
| • Estimate adverse event frequency and severity and describe management practices | |
| • Evaluate outcomes related to enrollment in, utilization of, and satisfaction with patient support programs | |
| Secondary aims | • Describe response rates and safety in special populations |
| • Evaluate drug–drug interactions | |
| • Evaluate health outcomes and durability of clinical response/clinical remission and time to relapse/treatment failure | |
| • Evaluate optimal dosing of therapy (eg, escalation of dosing of biologics) | |
| • Determine predictors of treatment response | |
| • Evaluate outcomes and durability of clinical response specifically among those with extraintestinal manifestations | |
| • Evaluate corticosteroid use | |
| • Evaluate malignancies | |
| • Evaluate opportunistic infections | |
| • Evaluate paradoxical reactions to therapies | |
| • Evaluate PROs measures | |
| • Evaluate surgeries and hospitalizations |