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Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis (MANGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02011386
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Professor Mikkel Østergaard, Rigshospitalet, Denmark

Brief Summary:
The study investigates different criteria for remission based on MRI and circulating biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates factors that affect disease activity, function and participation by use of different questionnaires.

Condition or disease Intervention/treatment
Axial Spondyloarthritis Drug: Treatment

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Monitoring and Prediction of Clinical Response and Disease Course During Golimumab Therapy of Patients With Axial Spondyloarthritis
Actual Study Start Date : February 2013
Actual Primary Completion Date : February 14, 2017
Actual Study Completion Date : February 14, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Group/Cohort Intervention/treatment
Treatment
Treatment: Injection Golimumab 50 mg every month on the same date
Drug: Treatment
Other Name: Treatment: Injection Golimumab 50 mg every month on the same date




Primary Outcome Measures :
  1. Fulfillment of Bath Ankylosing Spondylitis (BASDAI50) (i.e. reduction of 50%) [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Changes in MRI assessment (score) [ Time Frame: Week 16 ]

Other Outcome Measures:
  1. Number (percentage) of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS response) [ Time Frame: Week 16 and 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with axial spondyloarthritis with moderate to high disease activity (BASDAI >= 40 mm), who are going to start treatment with tumor-necrosis-factor-alpha inhibitor.
Criteria

Inclusion Criteria:

  • Axial spondyloarthritis according to the ASAS classification criteria
  • Sacroiliitis on conventional X-rays or MRI.
  • Disease activity assessed by BASDAI >40 mm despite treatment with NSAID.
  • Clinical indication for tumor-necrosis-factor-alpha inhibitor treatment by the treating physician.

Exclusion Criteria:

  • No contraindications for tumor-necrosis-factor-alpha inhibitor
  • No contraindications for MRI
  • No contraindications in participation in a study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011386


Locations
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Denmark
Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology
Copenhagen, Denmark, 2000
Glostrup Hospital, Dep. of Rheumatology
Copenhagen, Denmark, 2600
Herlev Hospital, Dep. of Radiology
Copenhagen, Denmark, 2730
Gentofte Hospital, Dep. of Rheumatology
Copenhagen, Denmark, 2900
Nordsjællands Hospital Hillerød, Dep. of Rheumatology
Hillerød, Denmark, 3400
Køge Hospital, Dep. of Rheumatology
Køge, Denmark, 4600
Sponsors and Collaborators
Professor Mikkel Østergaard
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Mikkel Østergaard, Professor Glostrup Hospital, University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Mikkel Østergaard, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02011386    
Other Study ID Numbers: MANGO
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs