Switching From Adalimumab to Infliximab

Sponsor
University Hospital, Ghent
Study ID
NCT01338740
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab and Infliximab — DRUG
    Patients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab switch to Infliximab.

Study Details

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.

Key Dates

Start date
Apr 30, 2011
Status verified
Jan 2023
Primary completion
Feb 17, 2014
Completion
Feb 17, 2014

Study Design

Enrollment
21 participants (actual)

Arms

  • Arm: Switch from Adalimumab to Infliximab
    Moderately to severely active Crohn's disease patients with primary non-response or loss of response to Adalimumab, will switch to Infliximab.

Primary Outcome Measure

Assess efficacy of switching from Adalimumab to Infliximab. [ Time Frame: after 10 weeks ]

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