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

Phase 1

• Conditions: lcerative colitis; MedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-004583-56-GB
• Lead Sponsor: MSD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-23
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified