NCT03124121

Brief Summary

The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC). Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 4, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 5, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 1, 2021

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

2.1 years

First QC Date

April 4, 2017

Results QC Date

May 13, 2021

Last Update Submit

July 2, 2021

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Serum Golimumab Concentration (μg/ml)

    Evaluated using an enzyme-linked immunosorbent assay (ELISA)

    Week 6 during induction therapy and at the point of study entry during maintenance

Secondary Outcomes (7)

  • Number of Patients in Clinical Remission

    Week 14 during induction therapy and at the point of study entry during maintenance therapy

  • Faecal Calprotectin (μg/g)

    Week 14 during induction therapy and at the point of study entry during maintenance

  • Serum C-Reactive Protein (mg/L)

    Week 14 during induction therapy and at the point of study entry during maintenance

  • Serum Albumin (g/L)

    Week 14 during induction therapy and at the point of study entry during maintenance

  • Clinical UC Disease Activity

    Week 14 during maintenance therapy and at the point of study entry during maintenance

  • +2 more secondary outcomes

Study Arms (2)

Induction cohort

OTHER

Golimumab induction therapy

Drug: Golimumab

Maintenance cohort

OTHER

Golimumab maintenance therapy

Drug: Golimumab

Interventions

GolimumabDRUG

A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha

Also known as: Simponi
Induction cohortMaintenance cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or over
  • Moderate-to-severe UC, defined as:
  • SCCAI \> 5 and, i. A raised fecal calprotectin (\> 59 μg/g) or, ii. A raised CRP (\> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment
  • Commencing golimumab treatment
  • Written informed consent to participate
  • Sufficient English language skills to understand the patient information sheet and consent form
  • Aged 18 years or over
  • Receiving golimumab treatment for UC for over 18 weeks (6 injections)
  • Written informed consent to participate
  • Sufficient English language skills to understand the patient information sheet and consent form

You may not qualify if:

  • Contra-indication to golimumab: tuberculosis or severe infections
  • Imminent need for colectomy (i.e. colectomy is being planned)
  • Previous primary non-response to anti-TNF therapy in the opinion of the investigator
  • Previous treatment with more than one anti-TNF therapy (excluding golimumab)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

  • Samaan MA, Cunningham G, Tamilarasan AG, Beltran L, Pavlidis P, Ray S, Mawdsley J, Anderson SH, Sanderson JD, Arkir Z, Irving PM. Therapeutic thresholds for golimumab serum concentrations during induction and maintenance therapy in ulcerative colitis: results from the GO-LEVEL study. Aliment Pharmacol Ther. 2020 Jul;52(2):292-302. doi: 10.1111/apt.15808. Epub 2020 Jun 7.

    PMID: 32506695DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Dr Mark Samaan
Organization
Guy's & St Thomas' Hospital
mark.samaan@gstt.nhs.uk
07740637713

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 21, 2017

Study Start

September 5, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

July 6, 2021

Results First Posted

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)