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

N/ACompletedNCT02011386

Professor Mikkel Østergaard53 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Axial Spondyloarthritis

Interventions

TreatmentDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (6)

Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology

Copenhagen, Denmark

Glostrup Hospital, Dep. of Rheumatology

Copenhagen, Denmark

Herlev Hospital, Dep. of Radiology

Copenhagen, Denmark

Gentofte Hospital, Dep. of Rheumatology

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Time frame: Week 52

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 52

MRI Spine Remission

Maximum 1 disco-vertebral unit with inflammation present.

Time frame: Week 16

MRI-SPINE-50

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

Time frame: Week 16

Data from ClinicalTrials.gov

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