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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03557853 |
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Date of registration:
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05/06/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab
GO-COX |
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Scientific title:
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A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab) |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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39 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03557853 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Ekaterina Lukyanova, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MSD Pharmaceuticals LLC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult patients (>18 years of age) with definite AS (as per modified New York criteria)
2. Coxitis with BASRI-hip score 0-2
3. Newly prescribed golimumab according to usual clinical practice
4. Naïve to anti-TNFs or other biologic agents prior to initiation of golimumab as
indicated by the patient's medical records
5. Patient is enrolled after the investigator's decision to treat with golimumab, but
before initiation of treatment with golimumab
6. Patient was informed of the benefits and risks of golimumab as per normal practice
using the product leaflet
7. Signed informed consent form
Exclusion Criteria:
1. Any contraindication to golimumab in accordance to the label of Simponi®
2. BASRI-hip score 3-4
3. Any contraindication to MRI, e.g. previous hip joint replacement, heart pace maker.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Coxitis
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Intervention(s)
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Drug: Golimumab Injection
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Primary Outcome(s)
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Change of BASFI (Bath Ankylosing Spodylitis Functionality Index)
[Time Frame: From baseline to 12 months]
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Secondary Outcome(s)
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BASDAI (Bath AS Disease Activity Index)
[Time Frame: From baseline to 12 and 24 months]
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Change of BASFI (Bath Ankylosing Spodylitis Functionality Index)
[Time Frame: From baseline to 24 months]
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BASRI-hip (Bath Ankylosing Spondylitis Radiology Index)
[Time Frame: From baseline to 12 and 24 months]
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Change of ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)
[Time Frame: From baseline to 12 and 24 months]
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Change of BASMI (Bath Ankylosing Spodylitis Mobility Index)
[Time Frame: From baseline to 12 and 24 months]
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Secondary ID(s)
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MK-8259-021
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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