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slow recruitment rate
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The purpose of this study is to determine the efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.
Oral corticosteroids (CS) are the treatment of choice for moderate flares of ulcerative colitis (UC) in patients who are on 5-aminosalicylic acid (5ASA) maintenance therapy. However, the efficacy of oral CS is limited, with up to 50% of remission rate in the available randomized controlled trials (RCTs). By the other hand, uncompleted disease remission after CS use, that is, clinical but not endoscopic remission, has been associated with a higher risk of hospitalizations and need for immunomodulator or colectomy in UC. Uncontrolled data suggests that intravenous CS (IV CS) may increase the remission rate and also reduce the proportion of patients developing steroid-dependency after the index course of CS.
The hypothesis of this study is that the addition of a 3-day high-dose IV CS pulses schedule administered in the outpatient infusion unit, added to a conventional oral CS course increases the endoscopic remission rate and reduces the 1-year proportion of patients developing steroid-dependency.
This is a randomized, phase IV, open-label, multicenter, controlled study.
The planned number of patients to be included is 148, distributed in two treatment arms (with or without initial high-dose CS pulse), and stratified regarding disease onset and mesalazine use.
The main end-point will be the proportion of patients with steroid-free, clinical and endoscopic remission at 8 and 54 weeks, with no rescue therapies.
The demonstration of a higher efficacy of the proposed treatment schedule would impact on a lower requirement for conventional immunosuppressive therapy (thiopurines) and biological agents, reduced hospitalizations and surgery. Moreover, this treatment regimen allows an outpatient management of moderate flares.
Baseline characteristics will be analyzed by descriptive statistical analysis by conventional methods. Categorical variables will be compared using Mann-Whitney test and continuous variables by Student T test.
In order to evaluate the primary endpoint a Chi square test will be performed to compare the proportions of patients in both study groups that achieved clinical and endoscopic steroid-free remission at 8 weeks and is maintained without steroids or salvage therapy and with no rescue therapy up to 54 weeks.
Per protocol (PP) and intention-to-treat (IT) analysis will be made The Per Protocol analysis will include all participants who did adequately adhere to the protocol, in particular those who did received the total amount of the intervention.
Missing outcomes data will be treated as non-response imputation (NRI). The intention-to treat-analysis will only include all randomized patients in the analysis, all retained in the group to which they were allocated, except those patients with missing outcomes that did not completed treatment regimen due to SAE criteria or treatment failure.
In order to evaluate the secondary endpoints a Chi square test and a Student T test will be performed for both study groups.
Cumulative probabilities of relapse, steroid dependency and surgery will be evaluated in both groups by Kaplan-Meiery, and compared by using log-rank test.
Finally, association analysis of early clinical response, clinical and endoscopic remission at week 8 and week 8 and 54 will be performed by chi-square test and Student T test; those variables that reach a Pvalue ≤ 0.1 will be included in the logistic regression analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone & prednisone | Experimental | Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone |
|
| prednisone | Active Comparator | A decreasing conventional course of oral prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Intravenous bolus of methylprednisolone 0.5g/day for 3 consecutive days followed by a decreasing conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Endoscopic and Clincal Remission | The percentage of patients with steroid-free, endoscopic remission, with no rescue therapies. It has been measured by Mayo endoscopic subscore (MES). MES= 0 (no friability and granularity and intact vascular pattern). MES= 1 (mild erythema or decreased vascular pattern). MES= 2 (marked erythema, absent vascular pattern, friability, and erosions). MES= 3 (spontaneous bleeding and ulceration) | Change from baseline at week 8 |
| Percentage of Participants With Endoscopic and Clinical Remission | The proportions of patients with steroid-free, endoscopic remission, with no rescue therapies. It has been measured by Mayo endoscopic subscore (MES). MES= 0 (no friability and granularity and intact vascular pattern). MES= 1 (mild erythema or decreased vascular pattern). MES= 2 (marked erythema, absent vascular pattern, friability, and erosions). MES= 3 (spontaneous bleeding and ulceration) | Change from baseline at week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Clinical Remission | It was measured as a decrease in the Mayo index score from baseline of at least 3 points; and a decrease of at least 30% in the rectal bleeding variable of at least 1 point or with an absolute value of 0 or 1. The Mayo index score is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugeni Domènech, MD, PhD | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario Santiago de Compostela | Santiago de Compostela | A Coruña | Spain | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23040451 | Background | Dignass A, Lindsay JO, Sturm A, Windsor A, Colombel JF, Allez M, D'Haens G, D'Hoore A, Mantzaris G, Novacek G, Oresland T, Reinisch W, Sans M, Stange E, Vermeire S, Travis S, Van Assche G. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012 Dec;6(10):991-1030. doi: 10.1016/j.crohns.2012.09.002. Epub 2012 Oct 3. No abstract available. | |
| 13865152 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylprednisolone & Prednisone | Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone Methylprednisolone : Intravenous bolus of methylprednisolone 0.5g/day for 3 consecutive days followed by a decreasing conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) Prednisone: Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2019 |
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|
| Prednisone | Drug | Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) |
|
|
| Change from baseline at week 8. |
| Number of Participants With Adverse Events | Adverse events (AEs) were collected during the study, from informed consent until the last visit. | 12 months |
| Number of Participants With Serious Adverse Events | Serious Adverse Events (SAEs) were defined as any adverse event or adverse drug reaction that resulted in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, or caused a congenital anomaly/birth defect. | 12 months |
| Levels of C-reactive Protein | Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and C-reactive protein (mg/L) levels were measured. | Baseline |
| Levels of Serum Albumin | Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and Serum albumin determination. | Baseline |
| Levels of Faecal Calprotectin | Faecal samples were collected at baseline, frozen and stored at -20 Celsius degrees (ºC) for central measurement of faecal calprotectin (FC). | Baseline |
| Hospital Germans Trias i Pujol |
| Badalona |
| Barcelona |
| 08916 |
| Spain |
| Althaia, xarxa assistencial universitaria de Manresa | Manresa | Barcelona | 08243 | Spain |
| Consorci Corporació Sanitària Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital Moisès Broggi | Sant Joan Despí | Barcelona | 08970 | Spain |
| Consorci Hospitalari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| Hospital de Galdakao | Galdakao | Bilbao | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| hospital Puerta de Hierro-Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario de Ourense | Ourense | Ourense | 32005 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital General Universitario de Alicante | Alicante | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitari Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital De La Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | Spain |
| Mútua de Terrassa | Terrassa | 08227 | Spain |
| Hospital Clínico de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario General de Valencia | Valencia | 46010 | Spain |
| Hospital de Manises | Valencia | Spain |
| Hospital Universitari La Fe | Valencia | Spain |
| Hospital Universitario Río Hortega | Valladolid | 47012 | Spain |
| Background |
| BARON JH, CONNELL AM, KANAGHINIS TG, LENNARD-JONES JE, JONES AF. Out-patient treatment of ulcerative colitis. Comparison between three doses of oral prednisone. Br Med J. 1962 Aug 18;2(5302):441-3. doi: 10.1136/bmj.2.5302.441. No abstract available. |
| 8432442 | Background | Hawthorne AB, Record CO, Holdsworth CD, Giaffer MH, Burke DA, Keech ML, Hawkey CJ. Double blind trial of oral fluticasone propionate v prednisolone in the treatment of active ulcerative colitis. Gut. 1993 Jan;34(1):125-8. doi: 10.1136/gut.34.1.125. |
| 11871829 | Background | Sood A, Midha V, Sood N, Kaushal V, Awasthi G. Methylprednisolone acetate versus oral prednisolone in moderately active ulcerative colitis. Indian J Gastroenterol. 2002 Jan-Feb;21(1):11-3. |
| 21195796 | Background | Ardizzone S, Cassinotti A, Duca P, Mazzali C, Penati C, Manes G, Marmo R, Massari A, Molteni P, Maconi G, Porro GB. Mucosal healing predicts late outcomes after the first course of corticosteroids for newly diagnosed ulcerative colitis. Clin Gastroenterol Hepatol. 2011 Jun;9(6):483-489.e3. doi: 10.1016/j.cgh.2010.12.028. Epub 2010 Dec 31. |
| 7364320 | Background | Elliott PR, Powell-Tuck J, Gillespie PE, Laidlow JM, Lennard-Jones JE, English J, Chakraborty J, Marks V. Prednisolone absorption in acute colitis. Gut. 1980 Jan;21(1):49-51. doi: 10.1136/gut.21.1.49. |
| 22079262 | Background | Garcia-Planella E, Manosa M, Van Domselaar M, Gordillo J, Zabana Y, Cabre E, Lopez San Roman A, Domenech E. Long-term outcome of ulcerative colitis in patients who achieve clinical remission with a first course of corticosteroids. Dig Liver Dis. 2012 Mar;44(3):206-10. doi: 10.1016/j.dld.2011.10.004. Epub 2011 Nov 11. |
| 17988236 | Background | Rhodes JM, Robinson R, Beales I, Pugh S, Dickinson R, Dronfield M, Speirs CJ, Wilkinson P, Wilkinson SP. Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis. Aliment Pharmacol Ther. 2008 Feb 1;27(3):228-40. doi: 10.1111/j.1365-2036.2007.03569.x. Epub 2007 Nov 6. |
| 7129207 | Background | Berghouse LM, Elliott PR, Lennard-Jones JE, English J, Marks V. Plasma prednisolone levels during intravenous therapy in acute colitis. Gut. 1982 Nov;23(11):980-83. doi: 10.1136/gut.23.11.980. |
| 25066954 | Background | Llao J, Naves JE, Ruiz-Cerulla A, Marin L, Manosa M, Rodriguez-Alonso L, Cabre E, Garcia-Planella E, Guardiola J, Domenech E. Intravenous corticosteroids in moderately active ulcerative colitis refractory to oral corticosteroids. J Crohns Colitis. 2014 Nov;8(11):1523-8. doi: 10.1016/j.crohns.2014.06.010. Epub 2014 Jul 22. |
| 20091481 | Background | Ponticelli C, Glassock RJ, Moroni G. Induction and maintenance therapy in proliferative lupus nephritis. J Nephrol. 2010 Jan-Feb;23(1):9-16. |
| 12772803 | Background | Oshitani N, Kamata N, Ooiso R, Kawashima D, Inagawa M, Sogawa M, Iimuro M, Jinno Y, Watanabe K, Higuchi K, Matsumoto T, Arakawa T. Outpatient treatment of moderately severe active ulcerative colitis with pulsed steroid therapy and conventional steroid therapy. Dig Dis Sci. 2003 May;48(5):1002-5. doi: 10.1023/a:1023076318751. |
| 12352296 | Background | Sood A, Midha V, Sood N, Awasthi G. A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis. J Clin Gastroenterol. 2002 Oct;35(4):328-31. doi: 10.1097/00004836-200210000-00009. |
| 20090334 | Background | Nagata S, Shimizu T, Kudo T, Tomomasa T, Tajiri H, Yoden A, Kagimoto S, Tahara T, Ushijima K, Uchida K, Kobayashi A. Efficacy and safety of pulse steroid therapy in Japanese pediatric patients with ulcerative colitis: a survey of the Japanese Society for Pediatric Inflammatory Bowel Disease. Digestion. 2010;81(3):188-92. doi: 10.1159/000255379. Epub 2010 Jan 19. |
| 21624004 | Background | Kudo T, Nagata S, Ohtani K, Fujii T, Wada M, Haruna H, Shoji H, Ohtsuka Y, Shimizu T, Yamashiro Y. Pulse steroids as induction therapy for children with ulcerative colitis. Pediatr Int. 2011 Dec;53(6):974-9. doi: 10.1111/j.1442-200X.2011.03405.x. |
| 41258993 | Derived | Llao J, Manosa M, Martin-Arranz E, Zabana Y, Navarro-Llavat M, Teller M, Garcia-Planella E, Busquets D, Monfort D, Pineda JR, Gutierrez A, Villoria A, Menchen L, Bastida G, Garcia-Alonso FJ, Rivero M, Chaparro M, de Francisco R, Merino O, Rodriguez-Lago I, Barreiro-de Acosta M, Rodriguez-Fortunez P, Rodriguez-Jimenez C, Calafat M, Domenech E; CECUM study group of the GETECCU. Addition of pulse corticosteroids to oral prednisone in moderately active ulcerative colitis: a randomized, multicentre, open-label study by GETECCU. J Crohns Colitis. 2025 Dec 5;19(11):jjaf182. doi: 10.1093/ecco-jcc/jjaf182. |
| FG001 | Prednisone | A decreasing conventional course of oral prednisone Prednisone: Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylprednisolone & Prednisone | Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone Methylprednisolone : Intravenous bolus of methylprednisolone 0.5g/day for 3 consecutive days followed by a decreasing conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) Prednisone: Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) |
| BG001 | Prednisone | A decreasing conventional course of oral prednisone Prednisone: Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Active smokers | Count of Participants | Participants |
| ||||||||||||||||||
| Familial inflammatory bowel disease | Count of Participants | Participants |
| ||||||||||||||||||
| Extensive ulcerative colitis | This type of ulcerative colitis affects the entire colon. Continuous inflammation begins at the rectum and extends beyond the splenic flexure. | Count of Participants | Participants |
| |||||||||||||||||
| Oral mesalazine at inclusion | Count of Participants | Participants |
| ||||||||||||||||||
| Number of patients with Mayo Complete score at baseline | This baseline measure reports the number of participants with baseline Mayo Complete scores from 6 to 10" The Mayo complete score it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance evaluations. Each part is rated from 0 to 3, giving a total score of 0 to 12. RESULTS: A total score of 3 to 5 points indicates mildly active disease A total score of 6 to 10 points indicates moderately active disease A total score of 11 to 12 points indicates severely active disease. | Number | participants |
| |||||||||||||||||
| Severe endoscopic activity | Endoscopic activity was assessed using the Mayo endoscopic subscore (MES); it consists of a 4-point scale from inactive (grade 0) to a severely active disease (grade 3), based on endoscopic findings. 0= Normal or inactive disease.
| Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Endoscopic and Clincal Remission | The percentage of patients with steroid-free, endoscopic remission, with no rescue therapies. It has been measured by Mayo endoscopic subscore (MES). MES= 0 (no friability and granularity and intact vascular pattern). MES= 1 (mild erythema or decreased vascular pattern). MES= 2 (marked erythema, absent vascular pattern, friability, and erosions). MES= 3 (spontaneous bleeding and ulceration) | All patients participating in the study had to undergo an endoscopic assessment of at least >25cm from the anal verge at baseline and after 8 weeks. | Posted | Number | participants | Change from baseline at week 8 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Endoscopic and Clinical Remission | The proportions of patients with steroid-free, endoscopic remission, with no rescue therapies. It has been measured by Mayo endoscopic subscore (MES). MES= 0 (no friability and granularity and intact vascular pattern). MES= 1 (mild erythema or decreased vascular pattern). MES= 2 (marked erythema, absent vascular pattern, friability, and erosions). MES= 3 (spontaneous bleeding and ulceration) | All patients participating in the study had to undergo an endoscopic assessment of at least >25cm from the anal verge at baseline and after 54 weeks. | Posted | Number | Percentage of participants | Change from baseline at week 54 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Clinical Remission | It was measured as a decrease in the Mayo index score from baseline of at least 3 points; and a decrease of at least 30% in the rectal bleeding variable of at least 1 point or with an absolute value of 0 or 1. The Mayo index score is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. | All patients participating in the study had to undergo a clinical assessment at baseline and after 8 weeks. | Posted | Number | 95% Confidence Interval | percentage of participants | Change from baseline at week 8. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Adverse events (AEs) were collected during the study, from informed consent until the last visit. | Information on adverse events (AEs) were collected at all study visits via spontaneous patient reporting and patient interviews at each visit. | Posted | Count of Participants | Participants | 12 months |
|
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| Secondary | Number of Participants With Serious Adverse Events | Serious Adverse Events (SAEs) were defined as any adverse event or adverse drug reaction that resulted in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, or caused a congenital anomaly/birth defect. | Information on adverse events (AEs) were collected at all study visits via spontaneous patient reporting and patient interviews at each visit. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Levels of C-reactive Protein | Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and C-reactive protein (mg/L) levels were measured. | Laboratory assessments were conducted at baseline, and blood samples were collected for C-reactive protein determination. | Posted | Least Squares Mean | Inter-Quartile Range | mg/L | Baseline |
|
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| Secondary | Levels of Serum Albumin | Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and Serum albumin determination. | Analytical laboratory test at baseline were performed in all participants at baseline. Blood samples were taken for haematology, and Serum albumin was determined. | Posted | Least Squares Mean | Inter-Quartile Range | g/L | Baseline |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Levels of Faecal Calprotectin | Faecal samples were collected at baseline, frozen and stored at -20 Celsius degrees (ºC) for central measurement of faecal calprotectin (FC). | FC concentration was measured using the quantitative, chemiluminescent, sandwich immunoassay Calprotectin (LIASON® DiaSorin, Italy), with a measuring range of 5-8,000 mg/g. | Posted | Number | 95% Confidence Interval | mg/g | Baseline |
|
12 months
Clinically important AEs or adverse drug reactions were also considered serious regardless of whether they met the defined criteria and included important medical events requiring intervention to prevent one of the outcomes defined as serious.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methylprednisolone & Prednisone | Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone Methylprednisolone : Intravenous bolus of methylprednisolone 0.5g/day for 3 consecutive days followed by a decreasing conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) Prednisone: Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) | 0 | 36 | 1 | 36 | 25 | 36 |
| EG001 | Prednisone | A decreasing conventional course of oral prednisone Prednisone: Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d) | 0 | 39 | 6 | 39 | 21 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative colitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| pyrexia | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Malignant neoplasm of the ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| neurogenic tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Epstein Barr virus infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment | Anaemia |
|
| Sleeplessness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | sleeplessness |
|
| Excitability | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | Excitability |
|
| Hyperglucemia | Endocrine disorders | MedDRA 10.0 | Systematic Assessment | Hyperglucemia |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | Headache |
|
| Arterial hypertension | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment | Arterial hypertension |
|
| infections | Infections and infestations | MedDRA 10.0 | Systematic Assessment | infections |
|
| Heartburn | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment | Heartburn |
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| dizziness | Vascular disorders | MedDRA 10.0 | Systematic Assessment | dizziness |
|
| Hypertransaminaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment | Hypertransaminaemia |
|
| Arthromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment | Arthromyalgia |
|
| Tumours | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment | Tumours |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | Cough |
|
| Transient diplopia | Eye disorders | MedDRA 10.0 | Systematic Assessment | Transient diplopia |
|
| Limb oedema | Vascular disorders | MedDRA 10.0 | Systematic Assessment | Limb oedema |
|
| Hyponatraemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment | Hyponatraemia |
|
| Acne | Endocrine disorders | MedDRA 10.0 | Systematic Assessment | Acne |
|
| Acute renal dysfunction | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment | Acute renal dysfunction |
|
Early termination due to low patient recruitment rate, leading to the analysis of half of the proposed sample number.
Intellectual property uniquely belongs to the sponsor, although the restrictions will be subject to the terms established in the contract with each site.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eugeni Domènech | Grupo Español de Trabajo en Enfermedad de Crohn y colitis Ulcerosa | 635899553 | soporte@geteccu.org |
| Nov 22, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
Not provided
Not provided
| >=65 years |
|
| Male |
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| Superiority |
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|
A decreasing conventional course of oral prednisone
Prednisone: Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)
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