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Completed

NCT Number: NCT02011386

Novel MRI ANd Biomarkers in GOlimumab-treated 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.

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treatment

Drug

Other names: Treatment: Injection Golimumab 50 mg every month on the same date

Primary outcomes

  1. Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)

    Time frame: Week 52

    At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline

Secondary outcomes

  1. BASDAI 50% or 2.0 Improvement

    Time frame: Week 16

    At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.

  2. BASDAI 50% or 2.0 Improvement

    Time frame: Week 52

    At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.

  3. Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)

    Time frame: Week 16

    Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.

  4. Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)

    Time frame: Week 52

    Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.

  5. MRI Spine Remission

    Time frame: Week 16

    Maximum 1 disco-vertebral unit with inflammation present.

  6. MRI-SPINE-50

    Time frame: Week 16

    At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score.

Other outcomes

  1. MRI-SIJ-50

    Time frame: Week 16

    At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index

  2. MRI-PERIPH-50

    Time frame: Week 16

    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').

  3. MRI SI Joint Remission

    Time frame: Week 16

    Inflammation in 2 or fewer quadrants as assessed slice by slice across MRI slices that depict the cartilagenous compartment of the sacroiliac joints.

  4. MRI Peripheral Joints and Entheses Inflammation Remission

    Time frame: Week 16

    A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index.

Sponsors and collaborators

Lead sponsor

Professor Mikkel Østergaard

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: MANGO

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2013
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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