Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis

NCT04156984 | Completed Phase 4 FDA Drug

• 1 other identifier: 2019-001G
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

Partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. The current dosing regimen in European Union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with \<80 kg 50 mg q4 weeks. The investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. Furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. Higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.

Conditions

Ulcerative Colitis

Keywords

Pharmacokinetics; Pharmacodynamics; Safety; Golimumab; Reactive dose optimisation; Proactive dose optimisation; Golimumab concentration; Mucosal healing; Therapeutic drug monitoring; Inflammatory bowel disease; Personalized medicine; Comparisons of European with US label

Outcome Measures

Primary Outcomes (1)

• Endoscopic outcome

  Number of participants with mucosal healing at week 14 and week 50 on flexible rectosigmoidoscopy (recorded and assessed centrally by blinded reader if possible). Mucosal healing is defined as Mayo endoscopic score 0 or 1.

  50 weeks

Secondary Outcomes (2)

• Clinical outcome

  50 weeks

• Association of golimumab through levels and Anti-golimumab antibodies development on endoscopic and clinical outcome.

  50 weeks

Other Outcomes (2)

• Measurement of physical, social, and emotional status with The Short Inflammatory Bowel Disease Questionnaire.

  50 weeks

• Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0.

  50 weeks.

Study Arms (2)

Study arm

OTHER

Subjects treated with optimized dose of golimumab, irrespective of weight: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4 weeks. In case of disease flare: discontinuation of drug.

Drug: Golimumab Prefilled Syringe

Control arm

OTHER

Subjects treated according to current European Label (2019) based on body weight: 1. \<80kg: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 50 mg sc q4wk. In case of disease flare (defined as PRO-2 ≥1): dose optimization to 100 mg sc q4wk starting at week 6 or at any time during first year. 2. ≥80kg: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4wk. In case of disease flare (defined as PRO-2 ≥1): discontinuation of drug.

Drug: Golimumab Prefilled Syringe

Interventions

Golimumab Prefilled Syringe DRUG

See arm description

Control arm; Study arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed ulcerative colitis

You may not qualify if:

• Active tuberculosis or other opportunistic bacterial, viral and fungal infections
• History of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure
• Pregnancy
• History of allergic reactions to sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate80, water for injections.

Sponsors & Collaborators

• David Drobne: lead

Study Sites (4)

General hospital Celje, Department of Gastoenterology

Celje, 3000, Slovenia

Location

General hospital Izola, Department of Internal medicine

Izola, 6310, Slovenia

Location

University Medical Centre Ljubljana, Department of Gastroenterology

Ljubljana, 1000, Slovenia

Location

University Medical Centre Maribor, Department of Gastoenterology

Maribor, 2000, Slovenia

Location

Related Publications (1)

• Stefanovic S, Detrez I, Compernolle G, Brouwers E, Sever N, Stabuc B, Smrekar N, Kurent T, Novak G, Kozelj M, Ferrante M, Gils A, Drobne D. Endoscopic remission can be predicted by golimumab concentrations in patients with ulcerative colitis treated with the changed label. Eur J Gastroenterol Hepatol. 2021 Jan;33(1):54-61. doi: 10.1097/MEG.0000000000001843.

  PMID: 32804854 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• David Drobne, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

• Borut Štabuc, MD, PhD

  University Medical Centre Ljubljana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 8, 2019
• Study Start: April 7, 2021
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (4)