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Optimization of Golimumab Treatment in Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

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

Golimumab treatment optimization.

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Golimumab, Inflammatory Bowel Disease, Optimization, Drug levels, Anti-drug antibody levels

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Joaquín Hinojosa del Val

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Week 6 Responders

Week 6 Non Responders

Arm Description

In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Correlation between mucosal healing and serum Golimumab levels.

An endoscopy will be performed at the end of the treatment and serum Golimumab levels will be measured.

Identification of cut-off values of serum golimumab concentration

Identify useful cut-off values of serum golimumab concentration for use in ulcerative colitis practice.

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.

Full Information

NCT ID

NCT03669029

First Posted

July 4, 2018

Last Updated

September 11, 2018

Sponsor

Hospital de Manises

Collaborators

General University Hospital of Valencia, Hospital Clínico Universitario de Valencia, Hospital de Sagunto, Hospital Universitario La Fe, Hospital General Universitario de Alicante, Hospital Universitario Doctor Peset, Hospital Arnau de Vilanova, Hospital Provincial de Castellon, Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03669029

Brief Title

Optimization of Golimumab Treatment in Ulcerative Colitis

Official Title

Optimization of Golimumab Treatment in Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Manises

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colitis, Ulcerative

Keywords

Golimumab, Inflammatory Bowel Disease, Optimization, Drug levels, Anti-drug antibody levels

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Week 6 Responders

Arm Type

Experimental

Arm Description

In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.

Arm Title

Week 6 Non Responders

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Golimumab treatment optimization.

Intervention Description

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

Primary Outcome Measure Information:

Title

Correlation between serum Golimumab levels and clinical response.

Description

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.

Time Frame

Week 6.

Title

Correlation between anti-Golimumab antibody levels and clinical response.

Description

Time Frame

Week 6.

Secondary Outcome Measure Information:

Title

Treatment optimization outcome.

Description

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.

Time Frame

Week 14

Title

Correlation between mucosal healing and serum Golimumab levels.

Description

An endoscopy will be performed at the end of the treatment and serum Golimumab levels will be measured.

Time Frame

Week 54

Title

Identification of cut-off values of serum golimumab concentration

Description

Identify useful cut-off values of serum golimumab concentration for use in ulcerative colitis practice.

Time Frame

Week 6

Title

Correlation between mucosal healing and anti-Golimumab antibody levels.

Description

An endoscopy will be performed at the end of the treatment and anti-Golimumab antibody levels will be measured.

Time Frame

Week 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joaquín Hinojosa del Val, MD

Phone

+34 651184296

jhinojosad@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Vanesa Carretero López

Phone

+34 96 184 50 65

vcarretero@hospitalmanises.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joaquín Hinojosa del Val, MD

Organizational Affiliation

Hospital de Manises

Official's Role

Principal Investigator

Facility Information:

Facility Name

Joaquín Hinojosa del Val

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

23299465

Citation

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Results Reference

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Citation

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Results Reference

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Citation

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PubMed Identifier

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Citation

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Citation

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Optimization of Golimumab Treatment in Ulcerative Colitis

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