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

NCT02011386 | Completed Results DMC

• 1 other identifier: MANGO
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 6

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.

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• BASDAI 50% or 2.0 Improvement

  Week 16

• BASDAI 50% or 2.0 Improvement

  Week 52

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

  Week 16

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

  Week 52

• MRI Spine Remission

  Week 16

Other Outcomes (4)

• MRI-SIJ-50

  Week 16

• MRI-PERIPH-50

  Week 16

• MRI SI Joint Remission

  Week 16

Study Arms (1)

Treatment

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

Drug: Treatment

Interventions

Treatment DRUG

Also known as: Treatment: Injection Golimumab 50 mg every month on the same date

Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Professor Mikkel Østergaard: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology

Copenhagen, 2000, Denmark

Location

Glostrup Hospital, Dep. of Rheumatology

Copenhagen, 2600, Denmark

Location

Herlev Hospital, Dep. of Radiology

Copenhagen, 2730, Denmark

Location

Gentofte Hospital, Dep. of Rheumatology

Copenhagen, 2900, Denmark

Location

Nordsjællands Hospital Hillerød, Dep. of Rheumatology

Hillerød, 3400, Denmark

Location

Køge Hospital, Dep. of Rheumatology

Køge, 4600, Denmark

Location

Related Publications (3)

• Lorincz M, Ostergaard M, Wetterslev M, Sorensen IJ, Madsen OR, Christiansen SN, Hetland ML, Bakkegaard M, Klarlund M, Duer A, Boesen M, Gosvig KK, Pedersen SJ. Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis. RMD Open. 2024 Dec 20;10(4):e004948. doi: 10.1136/rmdopen-2024-004948.

  PMID: 39794273 DERIVED

• 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.

  PMID: 32310294 DERIVED

• 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.

  PMID: 31673422 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Professor Mikkel Østergaard, MD, PhD, DMSc
• Organization: Rigshospitalet, Denmark

mo@dadlnet.dk

+45 38633014

Study Officials

• Mikkel Østergaard, Professor

  Glostrup Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 13, 2013
• Study Start: February 1, 2013
• Primary Completion: February 14, 2017
• Study Completion: February 14, 2017
• Last Updated: August 17, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-07

Locations

DK (6)