Early MOnitoring of REsponse on the therapy of Golimumab (GLM) with fecal calprotectin and trough serum levels in patients with ulcerative colitis. A multicentric, prospective study

Early MOnitoring of REsponse on the therapy of Golimumab (GLM) with fecal calprotectin and trough serum levels in patients with ulcerative colitis. A multicentric, prospective study - MORE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005940

Enrollment

Registered

2014-09-23

Start date

2014-10-24

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K51.9

Interventions

Group 1: In patientes with ulcerative colitis fecal calprotectin and serum GLM and anti-GLM level are analyzed. Calprotectin will be monitored in week 0, 2, 6, 14, 22 and 26. GLM level will be monitor

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Established diagnosis of ulcerative colitis by endoscopical and clinical determination 2. Trial-independend treatment with golimumab according to routine local prescribing practice at the discretion of the investigator 3. Minimum age of 18 years 4. The patient must be capable in communicating sufficiently in German 5. The patient must be able to recognize the nature, significance and scope of the study and must agree in a written informed consent. 6. Increased level of calprotectin (=100 mg/l or =100 mg/kg) within 3 weeks prior to inclusion or existing endoscopic record of a distinct inflammatory response (UCEIS = 3 points).

Exclusion criteria

Exclusion criteria: 1. Infectious colitis 2. Treatment with Golimumab outside the label 3. Treatment with Golimumab within the last 3 month

Design outcomes

Primary

Measure	Time frame
To evaluate a 50% reduction of fecal calprotectin and a positive GLM trough level at week 6 to predict clinical response at week 26.	—

Secondary

Measure	Time frame
1. At which point in time is a reduction of 50% of calprotectin a reliable predictor of response? 2. How strong is the correlation between Antibodies-Towards-GLM (ATG) and fecal calprotectin? 3. How strong is the correlation between ATG and Partial Mayo Score? 4. How strong is the correlation between GLM trough level and fecal calprotectin? 5. How strong is the correlation between GLM trough level and Partial Mayo Score. 6. Are serum CRP levels, leucocyte count, hemoglobin levels, thrombocyte count or ferritin levels constraining factors for the clinical response due to GLM treatment?	—

Measure

Time frame

1. At which point in time is a reduction of 50% of calprotectin a reliable predictor of response? 2. How strong is the correlation between Antibodies-Towards-GLM (ATG) and fecal calprotectin? 3. How strong is the correlation between ATG and Partial Mayo Score? 4. How strong is the correlation between GLM trough level and fecal calprotectin? 5. How strong is the correlation between GLM trough level and Partial Mayo Score. 6. Are serum CRP levels, leucocyte count, hemoglobin levels, thrombocyte count or ferritin levels constraining factors for the clinical response due to GLM treatment?

—

Countries

Germany

Contacts

Public ContactUlf Helwig

Internistische Praxisgemeinschaft Oldenburg

helwig@internisten-ol.de+49 441 3613150

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 1, 2026