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

NCT ID: NCT01029847

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Adalimumab

TNF-alpha inhibitor

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Professor Mikkel Østergaard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikkel Østergaard, Professor

Role: PRINCIPAL_INVESTIGATOR

Dep. of Rheumatology, Glostrup Hospital

Susanne J Pedersen, MD

Role: STUDY_CHAIR

Dep. of Rheumatology, Glostrup Hospital

Inge J Sørensen

Role: STUDY_CHAIR

Dep. of Rheumatoogy, Glostrup Hospital

Locations

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

Copenhagen, , Denmark

Dep. of Rheumatology, Helsinør Hospital

Hørsholm, , Denmark

Dep. of Rheumatology, Køge Hospital

Køge, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 30936290 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29556419 (View on PubMed)

Other Identifiers

ASIM

Identifier Type: -

Identifier Source: org_study_id