Efficacy of Golimumab in Maintaining Deep Remission in UC Patients in Prolonged Remission With Infliximab
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Efficacy and Safety of Golimumab in Maintaining Deep Remission and Quality of Life in Ulcerative Colitis Patients in Deep Prolonged Remission With Infliximab. An Open Label, Non Interventional One Year Study.
1 other identifier
observational
50
1 country
1
Brief Summary
This study monitors the efficacy and safety of Golimumab in maintaining deep remission and quality of life in Ulcerative Colitis patients in deep prolonged remission with Infliximab. Patients will be followed up for one year and they will be assessed with biochemical tests (C-Reactive Protein , Full Blood Count , Faecal Calprotectin),endoscopic evaluation (MAYO Score) and finally histologically.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedMay 11, 2020
May 1, 2020
3.8 years
July 7, 2016
May 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of golimumab in maintaining deep remission with patients with UC. Patient will complete the short Inflammatory Bowel Disease Questionnaire (short SIBDQ) and Treatment Satisfaction Questionnaire for Medication (TSQM) form.
The primary outcome will be to assess the efficacy o Golimumab to maintain deep remission of UC
1 year
Eligibility Criteria
Ulcerative colitis patients in deep remission after 2 years of infliximab administration
You may qualify if:
- Clinical remission as assessed by PROs 1 and 2 of the Mayo score
- Biochemical remission, as assessed by a normal full blood count, erythrocyte sedimentation rate, C-Reacting Protein, and faecal calprotectin,
- Endoscopic remission, defined as an endoscopic subscore of the Mayo score equal to 0 or 1.
- Written informed consent.
You may not qualify if:
- Flare up of Ulcerative Colitis.
- Non endoscopic remission.
- Co-administration of Immunosuppressive drugs or/and topical use of Mesalazine.
- Allergic reaction to Infliximab or previously Infliximab dose over 5mg/Kg/8 weeks.
- Infection during study.
- Consent form not signed by the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evangelismos Hospital
Athens, Attica, 10676, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikos Viazis, Director
Evangelismos Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director gastroenterologist
Study Record Dates
First Submitted
July 7, 2016
First Posted
August 16, 2016
Study Start
June 1, 2016
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
May 11, 2020
Record last verified: 2020-05