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

Spondyloarthritis Clinical Trial

— ASIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029847
• Other study ID #: ASIM
• Status: Completed
• Phase: Phase 4
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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-a 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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
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	Copenhagen
Denmark	Dep. of Rheumatology, Helsinør Hospital	Hørsholm
Denmark	Dep. of Rheumatology, Køge Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%		24 weeks
Secondary	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