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Colitis, UlcerativePhase 4NCT03669029

Optimization of Golimumab Treatment in Ulcerative Colitis

A Phase 4 study testing Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg and Golimumab treatment optimization. in people with Colitis, Ulcerative, run by Hospital de Manises at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg and Golimumab treatment optimization.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
1 Oct 2018to 31 Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Joaquín Hinojosa del Val, MD contact

+34 651184296

jhinojosad@gmail.com

Vanesa Carretero López contact

+34 96 184 50 65

vcarretero@hospitalmanises.es

Spain1 site

  • Joaquín Hinojosa del Val

    Manises, Valencia, 46940

Other trials in Spain

About this study

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.

Being tested
Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg, Golimumab treatment optimization.
Keywords
Golimumab, Inflammatory Bowel Disease, Optimization, Drug levels, Anti-drug antibody levels
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Golimumab treatment optimization.Drug

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

Study groups in NCT03669029
Study groupRoleWhat they receive
Week 6 RespondersExperimentalIn patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.
Receives: Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg
Week 6 Non RespondersExperimentalIn patients without clinical response at week 6, golimumab treatment will be optimized.
Receives: Drug: Golimumab treatment optimization.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 6.

  2. 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.

    Measured: Week 6.

Secondary outcomes (4)

  1. 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.

    Measured: Week 14

  2. 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.

    Measured: Week 54

  3. Identification of cut-off values of serum golimumab concentration

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

    Measured: Week 6

  4. 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.

    Measured: Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2018
  2. Study start1 Oct 2018 (estimated)
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03669029
Sponsor's protocol ID
JHV-GOL-2018-01
Status last verified
Sep 2018
First submitted
4 Jul 2018
Last updated
13 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23299465

  • 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.

    PubMed 21330576

  • 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.

    PubMed 22357456

  • 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.

    PubMed 22344964

  • 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.

    PubMed 21741088

  • 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.

    PubMed 19756557

  • 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.

    PubMed 23735746

  • 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.

    PubMed 23770005

  • 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.

    PubMed 27440869

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg and Golimumab treatment optimization. in people with Colitis, Ulcerative, run by Hospital de Manises at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joaquín Hinojosa del Val, MD (+34 651184296, jhinojosad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between serum Golimumab levels and clinical response. (time frame: Week 6.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03669029, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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