The Norwegian Antirheumatic Drug Register (NOR-DMARD)

Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Joint Diseases

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Eirik K Kristianslund, MD, PhD; Email: eirik.kristianslund@gmail.com
• Study Contact Backup: Name: Espen A Haavardsholm, MD, PhD; Phone Number: +4722454086; Email: e.a.haavardsholm@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0319
    • Recruiting
    • Diakonhjemmet Hospital
    • Contact: Eirik K Kristianslund, MD, PhD; Email: eirik.kristianslund@gmail.com
    • Contact: Espen A Haavardsholm, MD, PhD; Phone Number: +4722454086; Email: e.a.haavardsholm@medisin.uio.no
    • Principal Investigator: Tore K Kvien, MD, PhD
    • Sub-Investigator: Eirik K Kristianslund, MD, PhD
    • Sub-Investigator: Espen A Haavardsholm, MD, PhD
  • Buskerud
    • Drammen, Buskerud, Norway, 3004
      • Completed
      • Vestre Viken HF Drammen Hospital
  • Oppland
    • Lillehammer, Oppland, Norway, 2609
      • Recruiting
      • Lillehammer Hospital for Rheumatic Diseases
      • Contact: Yi Hu, MD PhD; Email: Yi.Hu@revmatismesykehuset.no
      • Principal Investigator: Yi Hu, MD PhD
  • Sogn Og Fjordane
    • Førde, Sogn Og Fjordane, Norway, 6807
      • Recruiting
      • Førde Hospital
      • Contact: Pawel F Mielnik, MD, PhD; Phone Number: +4757839000; Email: pawel.franciszek.mielnik@helse-forde.no
      • Principal Investigator: Pawel F Mielnik, MD, PhD
  • Sør-Trøndelag
    • Trondheim, Sør-Trøndelag, Norway, 7006
      • Completed
      • St. Olavs Hospital
  • Troms
    • Tromsø, Troms, Norway, 9038
      • Recruiting
      • University Hospital of Northern Norway
      • Contact: Synøve Kalstad, MD; Phone Number: +4791507766; Email: Synove.Kalstad@unn.no
      • Principal Investigator: Synøve Kalstad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug

Description

Inclusion Criteria:

• Age >18 years
• Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, adult juvenile idiopathic arthritis, undifferentiated arthritis, or any other inflammatory arthritis
• Clinical indication to start a new treatment with a biological disease modifying anti-rheumatic drug or a kinase inhibitor

Exclusion Criteria:

• Unwillingness or unability to give written informed consent
• Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible
• Participation in blinded RCTs or other studies incompatible with the NOR-DMARD study protocol

Study Plan

How is the study designed?

What is the study measuring?

Secondary Outcome Measures

Outcome Measure	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)		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

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: Vestre Viken Hospital Trust; University Hospital of North Norway; St. Olavs Hospital; Helse Forde; Lillehammer Hospital for Rheumatic Diseases
• Investigators: Principal Investigator: Tore K Kvien, MD, PhD, Diakonhjemmet Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2050
• Study Completion (ANTICIPATED): December 1, 2050

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (ESTIMATE): April 20, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Psoriatic arthritis; Rheumatoid arthritis; Ankylosing spondylitis; Spondyloarthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: DIA 2011-1