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Optimization of Golimumab Treatment in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03669029
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
Valencia University General Hospital
Hospital Clínico Universitario de Valencia
Hospital de Sagunt
Hospital Universitario La Fe
Hospital General Universitario de Alicante
Hospital Universitario Doctor Peset
Hospital Arnau de Vilanova
Hospital Provincial de Castellon
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hospital de Manises

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg Drug: Golimumab treatment optimization. Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization of Golimumab Treatment in Ulcerative Colitis
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Arm Intervention/treatment
Experimental: Week 6 Responders
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
Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels.

Experimental: Week 6 Non Responders
In patients without clinical response at week 6, golimumab treatment will be optimized.
Drug: Golimumab treatment optimization.
Golimumab dosing will be optimized in patients without clinical response at week 6.




Primary Outcome Measures :
  1. Correlation between serum Golimumab levels and clinical response. [ Time Frame: Week 6. ]
    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.

  2. Correlation between anti-Golimumab antibody levels and clinical response. [ Time Frame: Week 6. ]
    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.


Secondary Outcome Measures :
  1. Treatment optimization outcome. [ Time Frame: Week 14 ]
    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.

  2. Correlation between mucosal healing and serum Golimumab levels. [ Time Frame: Week 54 ]
    An endoscopy will be performed at the end of the treatment and serum Golimumab levels will be measured.

  3. Identification of cut-off values of serum golimumab concentration [ Time Frame: Week 6 ]
    Identify useful cut-off values of serum golimumab concentration for use in ulcerative colitis practice.

  4. Correlation between mucosal healing and anti-Golimumab antibody levels. [ Time Frame: Week 54 ]
    An endoscopy will be performed at the end of the treatment and anti-Golimumab antibody levels will be measured.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669029


Contacts
Contact: Joaquín Hinojosa del Val, MD +34 651184296 jhinojosad@gmail.com
Contact: Vanesa Carretero López +34 96 184 50 65 vcarretero@hospitalmanises.es

Locations
Spain
Joaquín Hinojosa del Val Enrolling by invitation
Manises, Valencia, Spain, 46940
Sponsors and Collaborators
Hospital de Manises
Valencia University General Hospital
Hospital Clínico Universitario de Valencia
Hospital de Sagunt
Hospital Universitario La Fe
Hospital General Universitario de Alicante
Hospital Universitario Doctor Peset
Hospital Arnau de Vilanova
Hospital Provincial de Castellon
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Joaquín Hinojosa del Val, MD Hospital de Manises

Publications:
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
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

Responsible Party: Hospital de Manises
ClinicalTrials.gov Identifier: NCT03669029     History of Changes
Other Study ID Numbers: JHV-GOL-2018-01
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hospital de Manises:
Golimumab
Inflammatory Bowel Disease
Optimization
Drug levels
Anti-drug antibody levels

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs