Phase 4
Completed N=112
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
Source: ClinicalTrials.gov NCT03124121 ↗Enrolled (actual)
112
Serious AEs
3.6%
Results posted
Jul 2021
Primary outcomePrimary: Serum Golimumab Concentration (μg/ml) — 3.3; 2.4 ug/ml
◆ Published Evidence
Established
23citations · ~4 / year
Therapeutic thresholds for golimumab serum concentrations during induction and maintenance therapy in ulcerative colitis: results from the GO-LEVEL study.
Summary
The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).
Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.
Linked Publications
-
Therapeutic thresholds for golimumab serum concentrations during induction and maintenance therapy in ulcerative colitis: results from the GO-LEVEL study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Golimumab Concentration (μg/ml) |
3.3; 2.4 | — |
| SECONDARY Number of Patients in Clinical Remission |
22; 41 | — |
| SECONDARY Faecal Calprotectin (μg/g) |
46; 57 | — |
| SECONDARY Serum C-Reactive Protein (mg/L) |
1; 1 | — |
| SECONDARY Serum Albumin (g/L) |
46; 47 | — |
| SECONDARY Clinical UC Disease Activity |
1; 0 | — |
| SECONDARY Quality of Life (IBD-Control) |
12.5; 14 | — |
| SECONDARY Number of Patients With Detectable Anti-golimumab Antibodies |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria for cohort 1:
- Aged 18 years or over
- 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 study enrollment
- Commencing golimumab treatment
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Inclusion Criteria for cohort 2:
- Aged 18 years or over
- Receiving golimumab treatment for UC for over 18 weeks (6 injections)
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Exclusion Criteria (cohort 1 only):
- Contra-indication to golimumab: tuberculosis or severe infections
- 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)
Data sourced from ClinicalTrials.gov (NCT03124121) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.