Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy of switching to Infliximab in patients with loss of response or primary non-response to Adalimumab. Even in rheumatology, where switching between all classes of anti-TNFα biologicals is common practice, there are no scientific data on switching from humanized to chimeric anti-TNFα antibodies. The purpose of this study is to document the efficacy of such a switch and to identify the possible predictive factors for success. If treatment with Adalimumab fails (despite optimal dose and interval) and the treating physician therefore decided to switch to infliximab, the patient may be enrolled in this observational study. At regular intervals (every Remicade), the patient will be clinically re-evaluated. The disease activity score will be calculated: Crohn's disease activity index (CDAI). At regular intervals, the results of interim blood tests will be documented (3x). The succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken for determination of antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab (week 0) and Infliximab (week 10, 26 and 52) will be determined. For this study there is no specific therapy change. The study wants only to document the results of a therapy switch that, in current clinical practice, is made by the treating physician.
Study Type
OBSERVATIONAL
Enrollment
21
Patients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab switch to Infliximab.
Sint-Augustinus
Antwerp, Belgium
UZ Antwerpen
Antwerp, Belgium
Imelda Hospital
Bonheiden, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
ULB université libre (erasme)
Brussels, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
University Hospital Ghent
Ghent, Belgium
Virga Jesse hospital
Hasselt, Belgium
AZ Groeninge
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
...and 6 more locations
Assess efficacy of switching from Adalimumab to Infliximab.
The primary objective of the study is to assess the efficacy of switching to Infliximab for the induction of clinical remission in subjects with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab. The proportion of subjects achieving clinical remission at week 10 after 3 infusions of Infliximab (week 0, 2 and 6). Clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 or less.
Time frame: after 10 weeks
induction of clinical response
To assess the efficacy of switching from Adalimumab to Infliximab for the induction of clinical response. The proportion of subjects with clinical response (at least 70 point decrease in Crohn's Disease Activity Index (CDAI)) at week 10.
Time frame: after 10 weeks
induction of strong clinical response
To assess the efficacy of switching from Adalimumab to Infliximab for the induction of strong clinical response. The proportion of subjects with strong clinical response (at least 100 point decrease in CDAI) at week 10.
Time frame: after 10 weeks
Sustained Clinical Response
To assess the efficacy of switching from Adalimumab to Infliximab to achieve sustained clinical response, treating with maintenance Infliximab infusions. The proportion of subjects with sustained clinical response (at least 100 and 70 point decrease in CDAI) at weeks 26 and 52.
Time frame: after 26 and 52 weeks
Sustained Clinical Remission
To assess the efficacy of switching from Adalimumab to Infliximab to achieve sustained clinical remission, treating with maintenance Infliximab infusions. The proportion of subjects with sustained clinical remission (CDAI 150 or less) at weeks 26 and 52.
Time frame: after 26 and 52 weeks
Induction and maintenance of steroid-free remission.
To assess the efficacy of switching from Adalimumab to Infliximab for the induction and maintenance of steroid-free remission. The proportion of subjects with steroid-free remission (CDAI 150 or less) at weeks 10, 26 and 52.
Time frame: after 10, 26 and 52 weeks
Sustained clinical remission without need for Infliximab therapy optimization.
To assess the efficacy of switching from Adalimumab to Infliximab to achieve sustained clinical remission, treating with maintenance Infliximab infusions, without the need for Infliximab therapy optimization (interval shortening or dose increase). The proportion of subjects with sustained clinical remission (CDAI 150 or less) at weeks 26 and 52, without the need for Infliximab therapy optimization (interval shortening or dose increase).
Time frame: after 26 and 52 weeks
Treatment failure
To assess the treatment failure of switching from Adalimumab to Infliximab. The proportion of patients with treatment failure. Failure is defined as cessation of Infliximab due to intolerance or insufficient efficacy despite therapy optimization or the start or dose increase of any other Crohn's disease medication during the study (including corticosteroids, immunosuppressants and 5-aminosalicylic acid (5-ASA) analogues).
Time frame: during 52 weeks
Tolerance and safety for switching from Adalimumab to Infliximab.
Adverse events/Serious adverse events will be analysed. Hematology and biochemistry will be analysed at weeks 10, 26 and 52.
Time frame: After 10, 26 and 52 weeks.
Serological factors associated with switching from Adalimumab to Infliximab.
* C-Reactive Protein (CRP) at screening, weeks 10, 26 and 52. * Antibodies to Adalimumab at baseline, weeks 10, 26 and 52. * Trough level of Adalimumab at baseline. * Antibodies to Infliximab at weeks 10, 26 and 52. * Trough level of Infliximab at weeks 10, 26 and 52.
Time frame: after 10, 26 and 52 weeks
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