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

Improved Monitoring and Prediction of Clinical Response and Disease Course During Golimumab Therapy of Patients With Axial Spondyloarthritis

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.

Study Overview

• Status: Completed
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Drug: Treatment

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2000
    • Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology
  • Copenhagen, Denmark, 2600
    • Glostrup Hospital, Dep. of Rheumatology
  • Copenhagen, Denmark, 2730
    • Herlev Hospital, Dep. of Radiology
  • Copenhagen, Denmark, 2900
    • Gentofte Hospital, Dep. of Rheumatology
  • Hillerød, Denmark, 3400
    • Nordsjællands Hospital Hillerød, Dep. of Rheumatology
  • Køge, Denmark, 4600
    • Køge Hospital, Dep. of Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with axial spondyloarthritis with moderate to high disease activity (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at least 40 mm), who are going to start treatment with TNF inhibitor.

Description

Inclusion Criteria:

• Axial spondyloarthritis according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axial spondyloarthritis
• Sacroiliitis on conventional X-rays or Magnetic Resonance Imaging (MRI).
• Disease activity assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >40 mm despite treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAID).
• Clinical indication for tumor necrosis factor (TNF) inhibitor treatment by the treating physician.

Exclusion Criteria:

• No contraindications for TNF inhibitor
• No contraindications for MRI
• No contraindications in participation in a study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)	At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BASDAI 50% or 2.0 Improvement	At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.	Week 16
BASDAI 50% or 2.0 Improvement	At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.	Week 52
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)	Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.	Week 16
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)	Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.	Week 52
MRI Spine Remission	Maximum 1 disco-vertebral unit with inflammation present.	Week 16
MRI-SPINE-50	At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score.	Week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI-SIJ-50	At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index	Week 16
MRI-PERIPH-50	At least 50% reduction in MRI Peripheral Joints and Entheses Inflammation Index. MRIs of 74 peripheral joints were evaluated separately for synovitis and osteitis (i.e. bone marrow edema) and 30 peripheral entheses were evaluated separately for soft tissue inflammation and osteitis. All types of lesions (i.e. joint synovitis, joint osteitis, entheseal soft tissue inflammation and entheseal osteitis) were scored on a semi-quantitative scale of 0-2 ('none', 'mild', 'moderate to severe').	Week 16
MRI SI Joint Remission	Inflammation in 2 or fewer quadrants as assessed slice by slice across MRI slices that depict the cartilagenous compartment of the sacroiliac joints.	Week 16
MRI Peripheral Joints and Entheses Inflammation Remission	A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index.	Week 16

Collaborators and Investigators

• Sponsor: Professor Mikkel Østergaard
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Mikkel Østergaard, Professor, Glostrup Hospital, University of Copenhagen

Publications and helpful links

General Publications

• Krabbe S, Eshed I, Sorensen IJ, Moller J, Jensen B, Madsen OR, Klarlund M, Pedersen SJ, Ostergaard M. Novel whole-body magnetic resonance imaging response and remission criteria document diminished inflammation during golimumab treatment in axial spondyloarthritis. Rheumatology (Oxford). 2020 Nov 1;59(11):3358-3368. doi: 10.1093/rheumatology/keaa153.
• Krabbe S, Ostergaard M, Pedersen SJ, Weber U, Krober G, Makysmowych W, Lambert RGW. Canada-Denmark MRI scoring system of the spine in patients with axial spondyloarthritis: updated definitions, scoring rules and inter-reader reliability in a multiple reader setting. RMD Open. 2019 Oct 13;5(2):e001057. doi: 10.1136/rmdopen-2019-001057. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2013
• Primary Completion (ACTUAL): February 14, 2017
• Study Completion (ACTUAL): February 14, 2017

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (ESTIMATE): December 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: MANGO