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
Not provided
Not provided
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | sc. inj. Humira 40 mg every other week from week 0 to 52 |
|
| Measure | Description | Time Frame |
|---|---|---|
| EULAR response criteria | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of joints with inflammation on MRI | 16 and 52 weeks | |
| Erosions on X-rays and CT | 52 weeks | |
| Biomarkers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with rheumatoid arthritis according to the ACR criteria (1987) with high disease activity starting TNF-alpha inhibitor
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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of medicine, Herlev Hospital | Copenhagen | Denmark | ||||
| Dep. of Radiology, Herlev Hospital |
Not provided
Not provided
Not provided
Not provided
| 16 and 52 weeks |
| Copenhagen |
| Denmark |
| Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals | Copenhagen | Denmark |
| Dep. of Rheumatology, Gentofte Hospital | Copenhagen | Denmark |
| Dep. of Rheumatology, Glostrup Hospital | Copenhagen | Denmark |
| Dep. of Rheumatologym Glostrup Hospital | Copenhagen | Denmark |
| Dep. of Rheumatology, Helsingør Hospital | Hørsholm | Denmark |
| Dep. of Rheumatology, Køge Hospital | Køge | Denmark |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided