|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02868398 |
|
Date of registration:
|
07/07/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of Golimumab in Maintaining Deep Remission in UC Patients in Prolonged Remission With Infliximab
Switch |
|
Scientific title:
|
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. |
|
Date of first enrolment:
|
June 2016 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02868398 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
Nikos Viazis, Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Evangelismos Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- INCLUSION CRITERIA
- 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.
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Primary Outcome(s)
|
|
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.
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
143/27-06-2016
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|