SpondyloarthritisPhase 4ASIMNCT01029847
Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis
A Phase 4 study testing Adalimumab in people with Spondyloarthritis, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 8 sitesDenmark
- Study dates
- Dec 2009to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Dep. of medicine, Herlev Hospital
Copenhagen
Dep. of Radiology, Herlev Hospital
Copenhagen
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
Copenhagen
Dep. of Rheumatology, Gentofte Hospital
Copenhagen
Dep. of Rheumatology, Hvidovre Hospital
Copenhagen
Dep. of Rheumatologym Glostrup Hospital
Copenhagen
Dep. of Rheumatology, Helsinør Hospital
Hørsholm
Dep. of Rheumatology, Køge Hospital
Køge
About this study
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.
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
- Being tested
- Adalimumab, Placebo
- Keywords
- Patients with axial spondyloarthritis
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Adalimumab | Active comparator | TNF-alpha inhibitor Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
Measured: 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.
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Mikkel Østergaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mikkel Østergaard, Professor, Principal investigator, Dep. of Rheumatology, Glostrup HospitalSusanne J Pedersen, MD, Study chair, Dep. of Rheumatology, Glostrup HospitalInge J Sørensen, Study chair, Dep. of Rheumatoogy, Glostrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029847
- Sponsor's protocol ID
- ASIM
- Acronym
- ASIM
- Status last verified
- Jan 2019
- First submitted
- 9 Dec 2009
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30936290Krabbe 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.
PubMed 29556419
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01029847
- Acronym / sponsor ID
- ASIM / ASIM
- Conditions
- Spondyloarthritis
- Keywords
- Patients with axial spondyloarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Adalimumab | Active comparator | Drug: AdalimumabTNF-alpha inhibitor |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabSc. 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. | Drug | Adalimumab |
| Placebosc. 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. | Drug | Placebo |
Primary outcome
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
Time frame: 24 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 30936290Krabbe 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.
- Derived from this study: PubMed 29556419Krabbe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel Østergaard, Professor principal investigator
Dep. of Rheumatology, Glostrup Hospital
Susanne J Pedersen, MD study chair
Dep. of Rheumatology, Glostrup Hospital
Inge J Sørensen study chair
Dep. of Rheumatoogy, Glostrup Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab in people with Spondyloarthritis, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50% (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.