Ulcerative ColitisPhase 4GO-COLITISNCT02092285
Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)
A Phase 4 study testing Golimumab in people with Ulcerative Colitis, run by Merck Sharp & Dohme LLC at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2014to 25 May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis
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.
Read the 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
- Being tested
- Golimumab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Also called Simponi®
50mg or 100mg solution for injection; subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Golimumab | Experimental | 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. Receives: Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54
The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.
Measured: Baseline (Week 0), Week 6, Week 30, Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study start9 May 2014
- Primary completion25 May 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092285
- Sponsor's protocol ID
- 8259-032
- Other IDs
- 2013-004583-56
- Acronym
- GO-COLITIS
- Status last verified
- Feb 2019
- First submitted
- 18 Mar 2014
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 30002864
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02092285
- Acronym / sponsor ID
- GO-COLITIS / 8259-032
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 9 May 2014 (actual)
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golimumab | Experimental | Drug: GolimumabThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolimumabAlso: Simponi®50mg or 100mg solution for injection; subcutaneous injection | Drug | Golimumab |
Primary outcome
Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54
Time frame: Baseline (Week 0), Week 6, Week 30, Week 54
The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30002864Probert 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.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Golimumab in people with Ulcerative Colitis, run by Merck Sharp & Dohme LLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54 (time frame: Baseline (Week 0), Week 6, Week 30, Week 54). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.