Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started Oct 2018

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

July 4, 2018

Completed

2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed

18 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed

Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

July 4, 2018

Last Update Submit

September 11, 2018

Conditions

Colitis, Ulcerative

Keywords

GolimumabInflammatory Bowel DiseaseOptimizationDrug levelsAnti-drug antibody levels

Outcome Measures

Primary Outcomes (2)

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.

Secondary Outcomes (4)

Treatment optimization outcome.
Week 14
Correlation between mucosal healing and serum Golimumab levels.
Week 54
Identification of cut-off values of serum golimumab concentration
Week 6
Correlation between mucosal healing and anti-Golimumab antibody levels.
Week 54

Study Arms (2)

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.

Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg

Week 6 Non Responders

EXPERIMENTAL

In patients without clinical response at week 6, golimumab treatment will be optimized.

Drug: Golimumab treatment optimization.

Interventions

Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kgDRUG

Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels.

Week 6 Responders

Golimumab treatment optimization.DRUG

Golimumab dosing will be optimized in patients without clinical response at week 6.

Week 6 Non Responders

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria.

You may not qualify if:

Patients with Crohn's disease or colitis pending classification
Patients with ileoanal pouch
Patients with perianal fistulas related to the disease
Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet.
Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections.
Patients with moderate or severe heart failure (NYHA grade III / IV)

Contact the study team to confirm eligibility.

Study Sites (1)

Joaquín Hinojosa del Val

Manises, Valencia, 46940, Spain

Location

Related Publications (11)

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.
PMID: 23299465BACKGROUND
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.
PMID: 21330576BACKGROUND
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.
PMID: 22357456BACKGROUND
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.
PMID: 22344964BACKGROUND
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.
PMID: 21741088BACKGROUND
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.
PMID: 19756557BACKGROUND
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.
PMID: 23735746BACKGROUND
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.
PMID: 23770005BACKGROUND
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.
PMID: 27440869BACKGROUND
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
BACKGROUND

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

golimumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

Joaquín Hinojosa del Val, MD
Hospital de Manises
PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquín Hinojosa del Val, MD

CONTACT

+34 651184296 jhinojosad@gmail.com

Vanesa Carretero López

CONTACT

+34 96 184 50 65 vcarretero@hospitalmanises.es

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

September 13, 2018

Study Start

October 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

ES(1)

Optimization of Golimumab Treatment in Ulcerative Colitis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Week 6 Responders

Week 6 Non Responders

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Week 6 Responders

Week 6 Non Responders

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations