Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis (ASIM)

Adalimumab in Axial Spondyloarthritis. An Investigation of Whole-body MRI, MRI of Sacroiliac Joints and Spine and Soluble Biomarkers of Joint Inflammation and Damage.

Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare ultrasound examination with wholebody MRI etc.

Study Overview

• Status: Completed
• Conditions: Spondyloarthritis
• Intervention / Treatment: Drug: Placebo; Drug: Adalimumab

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Dep. of medicine, Herlev Hospital
  • Copenhagen, Denmark
    • Dep. of Radiology, Herlev Hospital
  • Copenhagen, Denmark
    • Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
  • Copenhagen, Denmark
    • Dep. of Rheumatology, Gentofte Hospital
  • Copenhagen, Denmark
    • Dep. of Rheumatology, Hvidovre Hospital
  • Copenhagen, Denmark
    • Dep. of Rheumatologym Glostrup Hospital
  • Hørsholm, Denmark
    • Dep. of Rheumatology, Helsinør Hospital
  • Køge, Denmark
    • Dep. of Rheumatology, Køge Hospital

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

Description

Inclusion Criteria:

• Spondyloarthritis (SpA) according to the new ASAS criteria for axial SpA
• BASDAI > 40 mm despite NSAIDs
• Clinical indication for treatment with TNF-alpha inhibitor
• Age > 18 years old and < 85 years old
• Sufficient contraception for women
• Capable of giving informed consent
• Capable of complying with the examination program of the protocol

Exclusion Criteria:

• Pregnancy wish, pregnancy or breast-feeding
• DMARDs within 4 weeks prior to inclusion
• Oral, intra-articular or intramuscular glucocorticoid within 4 weeks prior to inclusion
• The use of other study drugs within 4 weeks prior to inclusion or less than 5 half-lives of the study drug before inclusion if this is more than 4 weeks
• The use of suspected disease-modifying or immunosuppressive drugs within 4 weeks prior to inclusion
• DMARDs are allowed during the study, but the dose cannot be changed from 4 weeks prior to inclusion through week
• Contraindications for TNF-α inhibitor treatment
• Contraindications for MRI
• Known recent drug or alcohol abuse
• Failure to provide written consent
• Incapable of complying with the examination program for physical or mental reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; sc. inj. placebo every other week, week 0, 2, and 4. Sc. inj. adalimumab 40 mg every other week from week 6. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.
Active Comparator: Adalimumab; TNF-alpha inhibitor	Drug: Adalimumab; Sc. inj. adalimumab 40 mg every other week for 42 to 48 weeks. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of peripheral and axial joints and entheses with inflammation, circulating biomarkers of inflammation, cartilage and bone metabolism, conventional clinical parameters and changes in these during treatment with adalimumab.	24 week

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Mikkel Østergaard, Professor, Dep. of Rheumatology, Glostrup Hospital; Study Chair: Susanne J Pedersen, MD, Dep. of Rheumatology, Glostrup Hospital; Study Chair: Inge J Sørensen, Dep. of Rheumatoogy, Glostrup Hospital

Publications and helpful links

General Publications

• Krabbe S, Eshed I, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Pedersen SJ, Ostergaard M. Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment. J Rheumatol. 2020 Jan;47(1):50-58. doi: 10.3899/jrheum.181159. Epub 2019 Apr 1.
• Krabbe S, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Lambert RGW, Maksymowych WP, Pedersen SJ, Ostergaard M. Inflammatory and structural changes in vertebral bodies and posterior elements of the spine in axial spondyloarthritis: construct validity, responsiveness and discriminatory ability of the anatomy-based CANDEN scoring system in a randomised placebo-controlled trial. RMD Open. 2018 Mar 16;4(1):e000624. doi: 10.1136/rmdopen-2017-000624. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 9, 2009
• First Posted (Estimate): December 10, 2009

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Patients with axial spondyloarthritis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: ASIM