To gain insights in the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and maintenance treatment.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Drug level of golimumab at several time points.
Secondary outcome
Development of anti-drug antibodies, fecal calprotectin, fecal golimumab drug
levels, serum CRP, albumin level, SCCAI, IBDQ, SF-36 and endoscopies at
different time points.
Background summary
Golimumab was recently registered for moderate to severe ulcerative colitis in
patients failing conventional treatment (5-aminosalicylates, corticosteroids
and/or immunomodulators, such as azathioprine and 6-mercaptopurine) or are
intolerant for such therapies. The efficacy and safety has been demonstrated in
clinical trials, but experience in daily clinical practice is lacking. Although
golimumab is a new treatment option for patients with moderate to severe
ulcerative colitis, there are still many patients who do not respond or have
loss of response to golimumab. Importantly, clinical efficacy during induction
and maintenance therapy seems to correlate with golimumab trough levels.
Patients in the higher serum concentration quartiles had more favourable
outcomes versus patients in the lower quartiles. This exposure * effect
relationship needs further research in order to determine the optimal
therapeutic window and possible clinical benefit of therapeutic drug
monitoring. Therefore, we aim to provide pharmacokinetic data of induction and
maintenance treatment in UC patients who will start with golimumab. Clinical
efficacy will be correlated with golimumab exposure (AUC, trough levels).
Moreover, we will try to determine the optimal therapeutic window for golimumab
serum levels. The hypothesis is that a suboptimal effect of golimumab in
moderate - severely active UC patients may be due to subtherapeutic serum
levels due to consumption of the antibody in the mucosal bowel compartment.
Study objective
To gain insights in the pharmacokinetics of golimumab in moderate to severe
Ulcerative Colitis after subcutaneous administration, during induction and
maintenance treatment.
Study design
Prospective multicenter observational study.
Study burden and risks
Patients will undergo 16 blood (15 cc) sample collections, 16 stool sample
collections and 3 endoscopies during 16 hospital visits in 1 year. They are
also asked to fill in a short questionnaire (9x). At endoscopy visits a
questionnaire regarding quality of life will be taken. Risks involved in
endoscopies are perforation or bleeding.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
-Age from 18 years, either male or female
-Moderate to severe Ulcerative Colitis (according to Mayo score (2 or 3) baseline Colonoscopy), both anti-TNF naïve and anti-TNF exposed patients will be included
-Baseline endoscopy
-Obtained written informed consent
Exclusion criteria
- Contra-indication to golimumab: TBC, severe infections or congestive heart failure.
- Imminent need for surgery
Design
Recruitment
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 |
|---|---|
| CCMO | NL48785.018.14 |