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

Primary Purpose

Spondyloarthritis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Adalimumab
Placebo
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring Patients with axial spondyloarthritis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Adalimumab

Arm Description

TNF-alpha inhibitor

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 9, 2009
Last Updated
January 2, 2019
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01029847
Brief Title
Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
Patients with axial spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
TNF-alpha inhibitor
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Østergaard, Professor
Organizational Affiliation
Dep. of Rheumatology, Glostrup Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susanne J Pedersen, MD
Organizational Affiliation
Dep. of Rheumatology, Glostrup Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Inge J Sørensen
Organizational Affiliation
Dep. of Rheumatoogy, Glostrup Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dep. of medicine, Herlev Hospital
City
Copenhagen
Country
Denmark
Facility Name
Dep. of Radiology, Herlev Hospital
City
Copenhagen
Country
Denmark
Facility Name
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
City
Copenhagen
Country
Denmark
Facility Name
Dep. of Rheumatology, Gentofte Hospital
City
Copenhagen
Country
Denmark
Facility Name
Dep. of Rheumatology, Hvidovre Hospital
City
Copenhagen
Country
Denmark
Facility Name
Dep. of Rheumatologym Glostrup Hospital
City
Copenhagen
Country
Denmark
Facility Name
Dep. of Rheumatology, Helsinør Hospital
City
Hørsholm
Country
Denmark
Facility Name
Dep. of Rheumatology, Køge Hospital
City
Køge
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30936290
Citation
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.
Results Reference
derived
PubMed Identifier
29556419
Citation
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.
Results Reference
derived

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

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