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
| Name | Class |
|---|---|
| University Hospital of North Norway | OTHER |
| St. Olavs Hospital | OTHER |
| Lillehammer Hospital for Rheumatic Diseases | OTHER |
| Vestre Viken Hospital Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
NOR-DMARD is a register-based longitudinal observational study of which the main objectives are to study the effectiveness of treatment of inflammatory joint diseases with biological disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease activity, health related quality of life, function and joint damage, and to study the long-term safety of such treatment. Other objectives include the assessment of cost-effectiveness of treatment, to identify and and validate clinical, genetic and immunological predictors of efficacy and adverse events, to assess the impact of treatment with biological DMARDs on work participation and work productivity, to investigate different strategies for use of biological DMARDs, to assess the performance of different outcome measures, and to ensure a systematic and timely follow-up of patients treated with biological DMARDs.
This study is a modification, and an extension, of the NOR-DMARD study that was conducted in 5 Norwegian rheumatology departments in the period 2000-2012. The study includes a structured follow-up with study visits at baseline (start of biological drug) and after 3, 6, 12 months and every 12 months thereafter. Each study visit includes clinical assessment, patient-reported outcomes and measurement of acute-phase reactants. The data collection also includes blood samples for biobank at baseline and 3 months. Serious adverse events data will be systematically recorded, but other adverse events can also be retrieved by linkage to other registers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score-28 (DAS28) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| Simplified Disease Activity Index (SDAI) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| Ankylosing Spondylitis Disease Activity Score (ASDAS) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| Modified Health Assessment Questionnaire (MHAQ) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| Rheumatoid Arthritis Impact of Disease (RAID) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eirik K Kristianslund, MD, PhD | Contact | eirik.kristianslund@gmail.com | ||
| Espen A Haavardsholm, MD, PhD | Contact | +4722454086 | e.a.haavardsholm@medisin.uio.no |
| Name | Affiliation | Role |
|---|---|---|
| Tore K Kvien, MD, PhD | Diakonhjemmet Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken HF Drammen Hospital | Completed | Drammen | Buskerud | 3004 | Norway | |
| Lillehammer Hospital for Rheumatic Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41168848 | Derived | Yoshida Y, Hammer HB, Sexton J, Nordberg L, Aga AB, Terslev L, Lillegraven S, Haarvardsholm EA. How to score the wrist joint by ultrasound: exploration of the most sensitive joint assessment during follow-up of early or established rheumatoid arthritis. Arthritis Res Ther. 2025 Oct 30;27(1):200. doi: 10.1186/s13075-025-03668-8. | |
| 32648248 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| OTHER |
| Helse Forde | OTHER |
Not provided
Not provided
Not provided
Samples (including serum, plasma and full blood) for biomarker or DNA/RNA discovery and validation will be collected and stored in a freezer at -70 C at visits at baseline and at the 3-month assessment.
| 3, 6, 9, 12, 18, 24, 36, 48, 60 months |
| Work Productivity and Activity Impairment (WPAI) Questionnaire | 3, 6, 9, 12, 18, 24, 36, 48, 60 months |
| EuroQol 5-dimensions (EQ-5D) questionnaire | Utility instrument | 3, 6, 9, 12, 18, 24, 36, 48, 60 months |
| 28-Swollen joint count | 3, 6, 9, 12, 18, 24, 36, 48, 60 months |
| 28-Tender joint count | All follow-up visits |
| Erythrocyte Sedimentation Rate (ESR) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months |
| C-Reactive Protein (CRP) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months |
| Sharp/van der Heijde score | Radiographic progression | 12, 24, 36, 48, 60 months |
| Number of participants with adverse events | 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months |
| Clinical Disease Activity Index (CDAI) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months |
| Recruiting |
| Lillehammer |
| Oppland |
| 2609 |
| Norway |
|
| Førde Hospital | Recruiting | Førde | Sogn Og Fjordane | 6807 | Norway |
|
| St. Olavs Hospital | Completed | Trondheim | Sør-Trøndelag | 7006 | Norway |
| University Hospital of Northern Norway | Recruiting | Tromsø | Troms | 9038 | Norway |
|
| Diakonhjemmet Hospital | Recruiting | Oslo | 0319 | Norway |
|
| Mielnik P, Sexton J, Lie E, Bakland G, Loli LP, Kristianslund EK, Rodevand E, Lexberg AS, Kvien TK. Does Older Age have an Impact on Rituximab Efficacy and Safety? Results from the NOR-DMARD Register. Drugs Aging. 2020 Aug;37(8):617-626. doi: 10.1007/s40266-020-00782-x. |
| 31783773 | Derived | Gehin JE, Goll GL, Warren DJ, Syversen SW, Sexton J, Strand EK, Kvien TK, Bolstad N, Lie E. Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study. Arthritis Res Ther. 2019 Nov 29;21(1):256. doi: 10.1186/s13075-019-2009-5. |
| 30508189 | Derived | Olsen IC, Lie E, Vasilescu R, Wallenstein G, Strengholt S, Kvien TK. Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry. Rheumatology (Oxford). 2019 Mar 1;58(3):481-491. doi: 10.1093/rheumatology/key338. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |