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

Axial Spondyloarthritis Clinical Trial

— MANGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011386
• Other study ID #: MANGO
• Status: Completed
• Start date: February 2013
• Est. completion date: February 14, 2017

Study information

• Verified date: July 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 14, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Intervention

Drug:
• Treatment

Locations

Country	Name	City	State
Denmark	Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology	Copenhagen
Denmark	Gentofte Hospital, Dep. of Rheumatology	Copenhagen
Denmark	Glostrup Hospital, Dep. of Rheumatology	Copenhagen
Denmark	Herlev Hospital, Dep. of Radiology	Copenhagen
Denmark	Nordsjællands Hospital Hillerød, Dep. of Rheumatology	Hillerød
Denmark	Køge Hospital, Dep. of Rheumatology	Køge

Sponsors (2)

Lead Sponsor	Collaborator
Professor Mikkel Østergaard	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MRI-SIJ-50	At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index	Week 16
Other	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
Other	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
Other	MRI Peripheral Joints and Entheses Inflammation Remission	A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index.	Week 16
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	MRI Spine Remission	Maximum 1 disco-vertebral unit with inflammation present.	Week 16
Secondary	MRI-SPINE-50	At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score.	Week 16