Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis
- Registration Number
- NCT04156984
- Lead Sponsor
- David Drobne
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Histologically confirmed ulcerative colitis
- Active tuberculosis or other opportunistic bacterial, viral and fungal infections
- History of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure
- Pregnancy
- History of allergic reactions to sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate80, water for injections.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm Golimumab Prefilled Syringe Subjects treated according to current European Label (2019) based on body weight: 1. \<80kg: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 50 mg sc q4wk. In case of disease flare (defined as PRO-2 ≥1): dose optimization to 100 mg sc q4wk starting at week 6 or at any time during first year. 2. ≥80kg: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4wk. In case of disease flare (defined as PRO-2 ≥1): discontinuation of drug. Study arm Golimumab Prefilled Syringe 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.
- Primary Outcome Measures
Name Time Method Endoscopic outcome 50 weeks 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.
- Secondary Outcome Measures
Name Time Method Clinical outcome 50 weeks 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).
Association of golimumab through levels and Anti-golimumab antibodies development on endoscopic and clinical outcome. 50 weeks 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.
Trial Locations
- Locations (4)
General hospital Celje, Department of Gastoenterology
🇸🇮Celje, Slovenia
University Medical Centre Ljubljana, Department of Gastroenterology
🇸🇮Ljubljana, Slovenia
General hospital Izola, Department of Internal medicine
🇸🇮Izola, Slovenia
University Medical Centre Maribor, Department of Gastoenterology
🇸🇮Maribor, Slovenia