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Partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. The current dosing regimen in European Union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with <80 kg 50 mg q4 weeks. The investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. Furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. Higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.
Partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. The current dosing regimen in European Union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with <80 kg 50 mg q4 weeks. The investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. Furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. Higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Other | Subjects treated with optimized dose of golimumab, irrespective of weight: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4 weeks. In case of disease flare: discontinuation of drug. |
|
| Control arm | Other | Subjects treated according to current European Label (2019) based on body weight:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab Prefilled Syringe | Drug | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic outcome | Number of participants with mucosal healing at week 14 and week 50 on flexible rectosigmoidoscopy (recorded and assessed centrally by blinded reader if possible). Mucosal healing is defined as Mayo endoscopic score 0 or 1. | 50 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | Number of participants in clinical remission at week 14, week 26, week 38 and week 50. Clinical remission is defined as PRO-2 (Patient-Reported Outcome) score 0 (no rectal bleeding and no diarrhea/altered bowel habit). | 50 weeks |
| Association of golimumab through levels and Anti-golimumab antibodies development on endoscopic and clinical outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of physical, social, and emotional status with The Short Inflammatory Bowel Disease Questionnaire. | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (score 10-70, poor to good HRQoL). The questionnaire will be answered at week 0, week 6, week 14, week 26, week 38, week 50. | 50 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Drobne, MD, PhD | University Medical Centre Ljubljana | Principal Investigator |
| Borut Å tabuc, MD, PhD | University Medical Centre Ljubljana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General hospital Celje, Department of Gastoenterology | Celje | 3000 | Slovenia | |||
| General hospital Izola, Department of Internal medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32804854 | Result | Stefanovic S, Detrez I, Compernolle G, Brouwers E, Sever N, Stabuc B, Smrekar N, Kurent T, Novak G, Kozelj M, Ferrante M, Gils A, Drobne D. Endoscopic remission can be predicted by golimumab concentrations in patients with ulcerative colitis treated with the changed label. Eur J Gastroenterol Hepatol. 2021 Jan;33(1):54-61. doi: 10.1097/MEG.0000000000001843. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 15, 2024 | Sep 9, 2024 | 3 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Measurement of golimumab through levels. Blood withdrawals will be preformed at prespecified time points in all patients: week 0, week 2, week 4, week 6, week 10, week 14, week 26, week 38 and week 50. Measurement of Anti-golimumab antibodies development. Blood withdrawals will be preformed at prespecified time points in all patients: week 2, week 4, week 6, week 10, week 14, week 26, week 38 and week 50. |
| 50 weeks |
| Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0. | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0. | 50 weeks. |
| Izola |
| 6310 |
| Slovenia |
| University Medical Centre Ljubljana, Department of Gastroenterology | Ljubljana | 1000 | Slovenia |
| University Medical Centre Maribor, Department of Gastoenterology | Maribor | 2000 | Slovenia |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |