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| Name | Class |
|---|---|
| General University Hospital of Valencia | OTHER |
| Hospital Clínico Universitario de Valencia | OTHER |
| Hospital de Sagunto | OTHER |
| Hospital Universitario La Fe |
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This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Week 6 Responders | Experimental | In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response. |
|
| Week 6 Non Responders | Experimental | In patients without clinical response at week 6, golimumab treatment will be optimized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg | Drug | Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between serum Golimumab levels and clinical response. | Serum Golimumab levels will be measured and clinical activity evaluation will be assessed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin. | Week 6. |
| Correlation between anti-Golimumab antibody levels and clinical response. | Anti-golimumab antibody levels will be measure and clinical activity evaluation will be performed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin. | Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment optimization outcome. | Analyze the percentage of non-responder patients or patients with partial response at week 6 who achieve response/remission at week 14 after treatment optimization. | Week 14 |
| Correlation between mucosal healing and serum Golimumab levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joaquín Hinojosa del Val, MD | Contact | +34 651184296 | jhinojosad@gmail.com | |
| Vanesa Carretero López | Contact | +34 96 184 50 65 | vcarretero@hospitalmanises.es |
| Name | Affiliation | Role |
|---|---|---|
| Joaquín Hinojosa del Val, MD | Hospital de Manises | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joaquín Hinojosa del Val | Manises | Valencia | 46940 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23299465 | Background | Dostalek M, Gardner I, Gurbaxani BM, Rose RH, Chetty M. Pharmacokinetics, pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies. Clin Pharmacokinet. 2013 Feb;52(2):83-124. doi: 10.1007/s40262-012-0027-4. | |
| 21330576 | Background | Vande Casteele N, Ballet V, Van Assche G, Rutgeerts P, Vermeire S, Gils A. Early serial trough and antidrug antibody level measurements predict clinical outcome of infliximab and adalimumab treatment. Gut. 2012 Feb;61(2):321; author reply 322. doi: 10.1136/gut.2010.236869. Epub 2011 Feb 17. No abstract available. |
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| 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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| ID | Term |
|---|---|
| C529000 | golimumab |
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| OTHER |
| Hospital General Universitario de Alicante | OTHER |
| Hospital Universitario Doctor Peset | OTHER |
| Hospital Arnau de Vilanova | OTHER |
| Hospital Provincial de Castellon | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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| Golimumab treatment optimization. | Drug | Golimumab dosing will be optimized in patients without clinical response at week 6. |
|
An endoscopy will be performed at the end of the treatment and serum Golimumab levels will be measured. |
| Week 54 |
| Identification of cut-off values of serum golimumab concentration | Identify useful cut-off values of serum golimumab concentration for use in ulcerative colitis practice. | Week 6 |
| Correlation between mucosal healing and anti-Golimumab antibody levels. | An endoscopy will be performed at the end of the treatment and anti-Golimumab antibody levels will be measured. | Week 54 |
| 22357456 | Background | Ordas I, Mould DR, Feagan BG, Sandborn WJ. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther. 2012 Apr;91(4):635-46. doi: 10.1038/clpt.2011.328. Epub 2012 Feb 22. |
| 22344964 | Background | Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16. |
| 21741088 | Background | Fasanmade AA, Adedokun OJ, Blank M, Zhou H, Davis HM. Pharmacokinetic properties of infliximab in children and adults with Crohn's disease: a retrospective analysis of data from 2 phase III clinical trials. Clin Ther. 2011 Jul;33(7):946-64. doi: 10.1016/j.clinthera.2011.06.002. Epub 2011 Jul 7. |
| 19756557 | Background | Fasanmade AA, Adedokun OJ, Ford J, Hernandez D, Johanns J, Hu C, Davis HM, Zhou H. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol. 2009 Dec;65(12):1211-28. doi: 10.1007/s00228-009-0718-4. Epub 2009 Sep 16. |
| 23735746 | Background | Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2. |
| 23770005 | Background | Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Rutgeerts P; PURSUIT-Maintenance Study Group. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14. |
| 27440869 | Background | Adedokun OJ, Xu Z, Marano CW, Strauss R, Zhang H, Johanns J, Zhou H, Davis HM, Reinisch W, Feagan BG, Rutgeerts P, Sandborn WJ. Pharmacokinetics and Exposure-response Relationship of Golimumab in Patients with Moderately-to-Severely Active Ulcerative Colitis: Results from Phase 2/3 PURSUIT Induction and Maintenance Studies. J Crohns Colitis. 2017 Jan;11(1):35-46. doi: 10.1093/ecco-jcc/jjw133. Epub 2016 Jul 20. |
| Background | Berends S, Strik A, van Egmond P, Brandse H, Mathôt R,D'Haens G, Löwenberg M. Pharmacokinetics of golimumab in patients with moderate tosevere ulcerative colitis. J Crohn´s Colitis 2016; 10 (suppl 1):s424 AP637 |
| Background | Hutas G. Berends S, Strik A, van Egmond P, Brandse H, Mathôt R,D'Haens G, Löwenberg M. Pharmacokinetics of golimumab in patients with moderate tosevere ulcerative colitis. J Crohn´s Colitis 2016; 10 (suppl 1):s424 AP637 |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |