Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-004583-56-GB
• Date of registration: 23/12/2013
• Prospective Registration: Yes
• Primary sponsor: MSD
• Public title: Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis
• Scientific title: Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis
• Date of first enrolment: 28/01/2014
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004583-56
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Ashlin Dunne
• Affiliation: MSD

• Name: Ashlin Dunne
• Affiliation: MSD

Key inclusion & exclusion criteria

Inclusion criteria:
A subject must meet all the criteria listed below to participate in the trial.
1. Each subject must have moderate-to-severe UC for at least 3 months (as defined by a partial Mayo score of 4 to 9, or full Mayo score of 6 to 12 inclusive at Week 0. If full Mayo is assessed an endoscopic subscore of =2 is required).
2. Each subject must provide written informed consent for the trial.
3. Each subject must be aged 18 years or over.
4. If the subject is currently receiving any of the following treatments for UC, they are eligible, providing they are on a stable dose for the required period of time:
i. Oral 5-amino salicylic acid (5-ASA) compound (e.g. sulfasalazine, mesalamine, olsalazine, balsalazide): stable dose for at least 2 weeks prior to baseline and during the study treatment period.
ii. Azathioprine / 6-mercaptopurine: stable dose for at least 2 weeks prior to baseline and during the study treatment period.
iii. Oral corticosteroids (prednisolone =30 mg/day or less or equivalent): stable dose for at least 2 weeks prior to baseline.
5. Each subject must have no evidence of active, or latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
6. Each subject must be eligible to start golimumab treatment according to the SmPC.
7. Each subject must be not have yet recieved anti-TNF therapy.
8. During the study and for 6 months after receiving the last administration of trial medication, women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization). Women of childbearing potential must test negative for pregnancy at screening and at Week 0.
9. Each subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial:
1. The subject displays clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon.
2. The subject has evidence of pathogenic bowel infection.
3. The subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn’s disease.
4. The subject has had surgery as a treatment for UC, or is likely to require surgery during the study period.
5. The subject has UC, which is confined to a proctitis (distal 15 cm or less).
6. The subject has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
7. The subject has a current immunisation with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline.
8. A female subject is pregnant or lactating, or planning pregnancy while enrolled in the study.
9. The subject has received agents that deplete B or T cells (specific immune cells) (eg, rituximab or alemtuzumab) within 12 months prior to study inclusion, or continue to manifest depletion of B or T cells more than 12 months after completion of therapy with lymphocyte-depleting agents.
10. The subject has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion.
11. The subject has used any investigational drugs within 30 days of Screening.
12. The subject or a family member is among the investigational or sponsor staff directly involved with this trial.
13. Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study or contraindications as defined in the SmPC.
14. The subject has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative colitis
MedDRA version: 16.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Simponi
Product Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: golimumab
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-200

Primary Outcome(s)

Secondary Objective: •To assess how effective golimumab is at inducing and maintaining a clinical response in patients with moderate to severe ulcerative colitis.
•To evaluate both the quality of life of UC sufferers and the amount of resource used in managing ulcerative colitis, including the number and length of time spent in hospital.
•To assess the changes in biological markers of inflammation (C-reactive protein, fecal calprotectin)

Main Objective: To assess how effective the study drug, golimumab, is at maintaining a clinical response in patients with moderate to severe ulcerative colitis. The clinical response will be assessed by partial Mayo score which takes into account number of stools per day, rectal bleeding and a general assessment performed by the doctor.

Timepoint(s) of evaluation of this end point: Final Analysis (Interim analysis may be undertaken if sufficient data are available to support the NICE Multiple Technology Assessment of anti-TNFs, including golimumab, for ulcerative colitis planned for the UK during the period of this study)

Primary end point(s): The primary outcome measure for this study is the proportion of subjects with a partial Mayo score response at the end of the maintenance treatment period - week 54.

Secondary Outcome(s)

Secondary end point(s): -Proportion of patients meeting partial Mayo score clinical response criteria at Week 6
-Proportion of patients in partial Mayo score response at each study visit
-Proportion of patients in partial Mayo score remission at each study visit
-Proportion of patients in partial Mayo score reminssion at study completion
-Change from baseline in IBDQ and EQ-5D at each study visit
-Change from baseline in CRP and fecal calprotectin
-Assessment of rates, duration and reasons for hospitalization

Timepoint(s) of evaluation of this end point: Final Analysis (Interim analysis may be undertaken if sufficient data are available to support the NICE Multiple Technology Assessment of anti-TNFs, including golimumab, for ulcerative colitis planned for the UK during the period of this study)

Secondary ID(s)

MK8259-032