Crohn's disease
Conditions
Interventions
Group 1: Patients with prior immunogenic secondary loss of response to IV infliximab and active Crohn’s disease (HBI = 5), for whom subcutaneous CT-P13 is clinically indicated.
Sponsors
TU Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Planned initiation of subcutaneous infliximab (CT-P13) as part of routine clinical care Active Crohn's disease (Harvey Bradshaw Index = 5) Diagnosis of Crohn's disease = 3 months Previous treatment with intravenous infliximab and documented immunogenic failure (defined as infliximab levels < 3 µg/ml with concurrent detection of anti-drug antibodies) and secondary loss of efficacy
Exclusion criteria
Exclusion criteria: Age <18 years Contraindications to subcutaneous infliximab Primary failure of intravenous infliximab or secondary, non-immunogenic failure of intravenous infliximab Patients who are currently receiving intravenous infliximab or have received it within the last 16 weeks Previous treatment with subcutaneous infliximab History of allergic reaction to intravenous infliximab Patients with a stoma or pouch Patients who are to be initiated on additional thiopurine or methotrexate therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of clinical remission at week 26: Crohn's disease: HBI = 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission (HBI = 4) at weeks 4, 8, 16, 26, and 52 Clinical response (HBI decrease of =3 points or achievement of remission as defined above) at weeks 4, 8, 16, 26, and 52 Clinical, steroid-free, and surgery-free remission at weeks 4, 8, 16, 26, and 52 Safety profile (adverse events) Quality of life (sIBDQ and IBD Disk) at weeks 4, 8, 16, 26, and 52 Therapeutic drug monitoring: Infliximab serum concentrations and antidrug antibodies at baseline and weeks 4, 8, 16, 26, and 52 | — |
Countries
Germany
Outcome results
None listed