Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Adalimumab | Active Comparator | TNF-alpha inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50% | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of medicine, Herlev Hospital | Copenhagen | Denmark | ||||
| Dep. of Radiology, Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30936290 | Derived | 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. | |
| 29556419 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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 |
| 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. |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |