Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab

An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003262-25-PT

Enrollment

Registered

2014-11-20

Start date

2014-12-12

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Trade Name: Simponi Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects with a diagnosis of moderate to severe ulcerative colitis will be selected to participate in the trial. Inclusion criteria: Age 18 years or older at time of enrollment; diagnosis of moderate to severe ulcerative colitis at inclusion (defined as a clinical Mayo score =6) including endoscopy that shows inflammation as judged by a Mayo endoscopy score =2; subject is eligible to receive golimumab as per product monograph; signed the informed consent 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 37 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: as per golimumab’s product monograph; history of asthma, autoimmune diseases, hypertension.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the correlation of serum soluble ST2 levels with endoscopic activity (endoscopic Mayo score) at week 6 in moderate to severe UC subjects under golimumab treatment. - To evaluate the correlation of serum soluble ST2 with histological activity (Geboes index) at week 6 in moderate to severe UC subjects under golimumab treatment. ; Secondary Objective: - Evaluate correlation of serum solubleS T2 levels with endoscopic activity (Mayo score) at Wk16 in moderate to severe UC subjects under golimumab - Evaluate correlation of serum soluble ST2 levels with histological activity (Geboes index) at week 16 in moderate to severe UC subjects under golimumab - Correlate serum soluble ST2 levels with fecal calprotectin, at wk 6 and wk16 in moderate to severe UC subjects under golimumab - Correlate serum soluble ST2 with clinical activity (total Mayo score) at wk6 and wk16 in moderate to severe UC subjects under golimumab - Evaluate the potential of serum soluble ST2 as a predictor of endoscopic response (endoscopic Mayo score) to golimumab in moderate to severe UC subjects - Evaluate correlation between serum soluble ST2 levels with maintenance of endoscopic response (endoscopic Mayo score) to golimumab - Correlate Mayo endoscopic score with UCEIS overall score at wk6 and wk16 in moderate to severe UC subjects under golimumab ; Primary end point(s): - endoscopic activity of disease (measured by endoscopy Mayo subscore) at 6 weeks in UC subjects receiving golimumab; - histological activity (measured by Geboes index score) at 6 weeks in UC subjects receiving golimumab. ;Timepoint(s) of evaluation of this	—

Measure

Time frame

Main Objective: - To evaluate the correlation of serum soluble ST2 levels with endoscopic activity (endoscopic Mayo score) at week 6 in moderate to severe UC subjects under golimumab treatment. - To evaluate the correlation of serum soluble ST2 with histological activity (Geboes index) at week 6 in moderate to severe UC subjects under golimumab treatment. ; Secondary Objective: - Evaluate correlation of serum solubleS T2 levels with endoscopic activity (Mayo score) at Wk16 in moderate to severe UC subjects under golimumab - Evaluate correlation of serum soluble ST2 levels with histological activity (Geboes index) at week 16 in moderate to severe UC subjects under golimumab - Correlate serum soluble ST2 levels with fecal calprotectin, at wk 6 and wk16 in moderate to severe UC subjects under golimumab - Correlate serum soluble ST2 with clinical activity (total Mayo score) at wk6 and wk16 in moderate to severe UC subjects under golimumab - Evaluate the potential of serum soluble ST2 as a predictor of endoscopic response (endoscopic Mayo score) to golimumab in moderate to severe UC subjects - Evaluate correlation between serum soluble ST2 levels with maintenance of endoscopic response (endoscopic Mayo score) to golimumab - Correlate Mayo endoscopic score with UCEIS overall score at wk6 and wk16 in moderate to severe UC subjects under golimumab ; Primary end point(s): - endoscopic activity of disease (measured by endoscopy Mayo subscore) at 6 weeks in UC subjects receiving golimumab; - histological activity (measured by Geboes index score) at 6 weeks in UC subjects receiving golimumab. ;Timepoint(s) of evaluation of this

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 16 weeks; Secondary end point(s): - the correlation between serum soluble ST2 with endoscopic activity of disease (measured by endoscopy Mayo subscore) at 16 weeks in UC subjects receiving golimumab, through the Spearman correlation coefficient; - the correlation between serum soluble ST2 histological activity (measured by Geboes index score) at 16 weeks in UC subjects receiving golimumab, through the Spearman correlation coefficient. - Serum soluble ST2 levels at baseline, Week 6 and Week 16 will be correlated with fecal calprotectin levels at baseline, week 6 and week 16 through Pearson correlation coefficient or Spearman correlation coefficient in case the normality assumption is not verified. The two biomarkers will be categorized by the cut-offs and Cohen's kappa coefficient will be obtained. - Serum soluble ST2 levels at baseline, week 6 and week 16 will be correlated with clinical activity (total Mayo score), through Spearman correlation coefficient. - Comparative analyses of means (active disease versus inactive disease at week 6) with serum ST2 at baseline and change between baseline and week 6. - Comparative analyses of subjects who achieved response at week 6 and maintained through week 16 versus subjects who did not maintain response, regarding serum soluble ST2 at baseline, week 6 and change between baseline and week 6. ROC curve analysis of the serum soluble ST2 at week 6 regarding maintenance of response between week 6 and 16 will be performed. This exploratory analysis will detect the cut-off levels of the serum soluble ST2 at week 6 associated with maintenance of respon	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 16 weeks; Secondary end point(s): - the correlation between serum soluble ST2 with endoscopic activity of disease (measured by endoscopy Mayo subscore) at 16 weeks in UC subjects receiving golimumab, through the Spearman correlation coefficient; - the correlation between serum soluble ST2 histological activity (measured by Geboes index score) at 16 weeks in UC subjects receiving golimumab, through the Spearman correlation coefficient. - Serum soluble ST2 levels at baseline, Week 6 and Week 16 will be correlated with fecal calprotectin levels at baseline, week 6 and week 16 through Pearson correlation coefficient or Spearman correlation coefficient in case the normality assumption is not verified. The two biomarkers will be categorized by the cut-offs and Cohen's kappa coefficient will be obtained. - Serum soluble ST2 levels at baseline, week 6 and week 16 will be correlated with clinical activity (total Mayo score), through Spearman correlation coefficient. - Comparative analyses of means (active disease versus inactive disease at week 6) with serum ST2 at baseline and change between baseline and week 6. - Comparative analyses of subjects who achieved response at week 6 and maintained through week 16 versus subjects who did not maintain response, regarding serum soluble ST2 at baseline, week 6 and change between baseline and week 6. ROC curve analysis of the serum soluble ST2 at week 6 regarding maintenance of response between week 6 and 16 will be performed. This exploratory analysis will detect the cut-off levels of the serum soluble ST2 at week 6 associated with maintenance of respon

—

Countries

Portugal

Contacts

Public ContactGlobal Clinical Trials Operations

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

george_philip@merck.com+12673055921

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026