Measuring levels of golimumab to improve the understanding of differences in its effectiveness amongst patients with ulcerative colitis
- Conditions
- lcerative Colitis (UC)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-001374-42-GB
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 112
Inclusion criteria for cohort 1:
•Aged 18 years or over
•Written informed consent to participate
•Moderate-to-severe UC, defined as:
-SCCAI > 5 and,
i.A raised fecal calprotectin (> 59 µg/g) or,
ii.A raised CRP (> 5 mg/L) or,
iii.Endoscopic disease activity Mayo 2 or above,
Evaluated within 4 weeks of screening
•Commencing golimumab treatment
•Sufficient English language skills to understand the patient information sheet and consent form
Inclusion criteria for cohort 2:
•Aged 18 years or over
•Written informed consent to participate
•Receiving golimumab treatment for UC over 14 weeks (have completed 6 injections at time of screening)
•Sufficient English language skills to understand the patient information sheet and consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112
•Contra-indication to golimumab: tuberculosis, severe infections or congestive cardiac failure
•Imminent need for colectomy (i.e. colectomy is being planned)
•Previous primary non-response to anti-TNF therapy in the opinion of the investigator
•Previous treatment with more than one anti-TNF therapy (excluding golimumab)
There are no relevant exclusion criteria for patients entering cohort 2.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To define a week 6 golimumab trough level concentration that predicts response at week 14.;<br> Secondary Objective: •To define golimumab trough level concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively.<br> •To define a golimumab trough threshold that is associated with remission during maintenance therapy.<br> ;Timepoint(s) of evaluation of this end point: Weeks 6 and 10;<br> Primary end point(s): Drug exposure to golimumab will be evaluated using serum trough level concentrations measured using a commercially available ELISA produced by Theradiag (LISA TRACKER) at weeks 6 and 10. Clinical UC disease activity will be evaluated using SCCAI with the following definitions:<br><br> Remission SCCAI = 2<br> Response SCCAI = 5, with a decrease by = 2<br> RelapseSCCAI = 5 (following a response)<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): UC disease activity assessments at each time point (weeks 6, 10 and 14) using PRO2, development of anti-drug antibodies, acute infusion reactions (allergic), fecal calprotectin, serum CRP measurements, albumin and QoL assessments using IBD-Control.;Timepoint(s) of evaluation of this end point: Weeks 6, 10 and 14