Clinical trial NCT02092285: Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)
Official title: Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of golimumab in maintaining a clinical response in participants with moderate-to-severe ulcerative colitis.

Detailed description: This study consists of a 1 week screening period, a 54 week treatment period, and a 12 week follow-up period, requiring a total of 7 trial site visits: Visit 1(screening visit, Week -1), Visit 2 (enrollment visit, Day 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 5 (Week 30) and Visit 6 (Week 54) and Visit 7 (follow-up visit, Week 66).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment.
* Has a rectal bleeding subscore of 1 or more at baseline.
* No evidence of active, or latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
* Must be eligible to start golimumab treatment according to the summary of product characteristics.
* Must be naïve to anti-tumor necrosis factor (anti-TNF) therapy.
* 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, implant, surgical sterilization).
* Women of childbearing potential must test negative for pregnancy at screening.
* Any prior azathioprine / 6-mercaptopurine use was initiated at least 12 weeks prior to enrollment with either stable dosing or discontinued treatment for the 4 weeks immediately prior to enrollment.

Exclusion Criteria:

* Clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon.
* Has evidence of pathogenic bowel infection.
* Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
* Has had surgery as a treatment for ulcerative colitis, or is likely to require surgery.
* Has ulcerative colitis which is confined to a proctitis (distal 15 cm or less).
* Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
* Has a current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline.
* Pregnant or lactating, or planning pregnancy while enrolled in the study.
* Has received agents that deplete B or T 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.
* Has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion.
* Has used any investigational drugs within 30 days of Screening.
* Has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
* Has received methotrexate within 12 weeks prior to enrollment
* Has received rectal corticosteroids or rectal 5-aminosalicylic acid (5-ASA) compounds within 2 weeks prior to enrollment (may be commenced if required after Week 6 in the study)

Primary outcomes:
measure: Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54
timeFrame: Baseline (Week 0), Week 6, Week 30, Week 54
Secondary outcomes:
Other outcomes:
Locations:
city: Hoddesdon
country: United Kingdom
facility: Merck Sharp & Dohme Ltd.
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Probert CS, Sebastian S, Gaya DR, Hamlin PJ, Gillespie G, Rose A, Tate H, Wheeler C, Irving PM. Golimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (Golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative Colitis). BMJ Open Gastroenterol. 2018 Jul 7;5(1):e000212. doi: 10.1136/bmjgast-2018-000212. eCollection 2018.