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

NCT01029847 | Completed Phase 4 DMC

• 1 other identifier: ASIM
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Spondyloarthritis

Keywords

Patients with axial spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%

  24 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Adalimumab

ACTIVE COMPARATOR

TNF-alpha inhibitor

Drug: Adalimumab

Interventions

Adalimumab DRUG

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.

Adalimumab

Placebo DRUG

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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Pregnancy wish, pregnancy or breast-feeding
• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (8)

Dep. of medicine, Herlev Hospital

Copenhagen, Denmark

Location

Dep. of Radiology, Herlev Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals

Copenhagen, Denmark

Location

Dep. of Rheumatology, Gentofte Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatology, Hvidovre Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatologym Glostrup Hospital

Copenhagen, Denmark

Location

Dep. of Rheumatology, Helsinør Hospital

Hørsholm, Denmark

Location

Dep. of Rheumatology, Køge Hospital

Køge, Denmark

Location

Related Publications (2)

• 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.

  PMID: 30936290 DERIVED

• 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.

  PMID: 29556419 DERIVED

MeSH Terms

Conditions

Spondylarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mikkel Østergaard, Professor

  Dep. of Rheumatology, Glostrup Hospital

  PRINCIPAL INVESTIGATOR

• Susanne J Pedersen, MD

  Dep. of Rheumatology, Glostrup Hospital

  STUDY CHAIR

• Inge J Sørensen

  Dep. of Rheumatoogy, Glostrup Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

DK (8)