To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with *standard of care* IFX…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients in corticosteroid-free remission (no steroids beyond
week 26), with endoscopic healing at week 54 and without surgery for the full
year.
Secondary outcome
- proportion of patients with sustained remission from week 14 on wards
- proportion of patients with sustained steroid free remission from week 14
onwards
- proportion of patients with sustained IFX levels > 3 µg/ml
- clinical (CDAI) laboratory (hsCRP, Fecal calprotectin) and endoscopic status
at all visits beyond week 14
- adverse events
- total use of drug
- need for resection
- new fistula or abscesses
- pharmaco-economic evaluation
Background summary
The development of infliximab (IFX), a monoclonal antibody targeting tumor
necrosis factor (TNF) has been a major advance in the treatment of Crohn's
disease. Clinical benefit has been demonstrated in both luminal and fistulizing
Crohn's disease.
Further research has focused on the optimal use of IFX and its potential to
induce mucosal healing. Several trials reported that mucosal healing was
associated with persistent measurable IFX trough levels in both CD and UC.
Based on this data, is has become clear that successful lFX treatment in CD
probably depends on persistent and sufficient IFX trough levels in the serum of
these patients. The 'ideal' trough level, however, has yet to be determined. It
may well be that the optimal threshold is highly individual, perhaps depending
on the inflammatory burden.
Study objective
To investigate whether sustained trough levels of IFX can be achieved using IFX
trough level measurements and adjustment of dosing based upon these levels by
means of two different standardized algorithms in comparison with *standard of
care* IFX treatment and its effects on clinical and endoscopic outcomes.
Study design
Multicenter, prospective, randomized study.
Intervention
Tailored treatment with infliximab.
Study burden and risks
The most common side effects of infliximab include somewhat higher
susceptibility to infections, mild to moderate skin reactions, fatigue and
arthralgia. These side effects are usually transient.
Side effects of colonoscopies include some abdominal discomfort and, extremely
rarely, perforation.
Blood drawing can cause discomfort, bruising or local pain.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years,
Active CD (CDAI>220) and signs of active inflammation as evidenced by elevated serum hsCRP levels (>5 mg/L) and/or elevated fecal calprotectin levels (>250 mcg/g) AND endoscopically visible ulcers,
Patients naïve to biologics with indication for starting anti-TNF therapy in accordance with national reimbursement criteria,
Exclusion criteria
Absence of endoscopically visible ulcers,
Prior use of biologic therapies,
Previous intolerance to azathioprine leading to drug discontinuation
Indication for immediate surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-003038-14-NL |
| CCMO | NL38609.018.11 |