Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)

NCT ID: NCT02092285

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-09
• Study Completion Date: 2016-05-25

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).

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Golimumab

The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

50mg or 100mg solution for injection; subcutaneous injection

Interventions

Golimumab

50mg or 100mg solution for injection; subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Simponi®

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Merck Sharp & Dohme Ltd.

Hoddesdon, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30002864 (View on PubMed)

Other Identifiers

2013-004583-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8259-032

Identifier Type: -

Identifier Source: org_study_id