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

• Conditions: K51.9; Ulcerative colitis, unspecified

• Registration Number: DRKS00005940
• Lead Sponsor: GISG Organisationsbüro Kompetenznetz Darmerkrankungen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-23
• Study Completion: 2018-06-21
• Results First Posted: 2022-11-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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