The Norwegian Antirheumatic Drug Register

NCT ID: NCT01581294

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2050-12-31

Brief Summary

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.

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.

Conditions

Inflammatory Joint Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Lillehammer Hospital for Rheumatic Diseases

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Helse Forde

OTHER

Sponsor Role: collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tore K Kvien

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tore K Kvien, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet Hospital

Locations

Vestre Viken HF Drammen Hospital

Drammen, Buskerud, Norway

Site Status: COMPLETED

Lillehammer Hospital for Rheumatic Diseases

Lillehammer, Oppland, Norway

Site Status: RECRUITING

Førde Hospital

Førde, Sogn Og Fjordane, Norway

Site Status: RECRUITING

St. Olavs Hospital

Trondheim, Sør-Trøndelag, Norway

Site Status: COMPLETED

University Hospital of Northern Norway

Tromsø, Troms, Norway

Site Status: RECRUITING

Diakonhjemmet Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Eirik K Kristianslund, MD, PhD

Role: CONTACT

eirik.kristianslund@gmail.com

Espen A Haavardsholm, MD, PhD

Role: CONTACT

e.a.haavardsholm@medisin.uio.no

+4722454086

Facility Contacts

Yi Hu, MD PhD

Role: primary

Yi.Hu@revmatismesykehuset.no

Pawel F Mielnik, MD, PhD

Role: primary

pawel.franciszek.mielnik@helse-forde.no

+4757839000

Synøve Kalstad, MD

Role: primary

Synove.Kalstad@unn.no

+4791507766

Eirik K Kristianslund, MD, PhD

Role: primary

eirik.kristianslund@gmail.com

Espen A Haavardsholm, MD, PhD

Role: backup

e.a.haavardsholm@medisin.uio.no

+4722454086

References

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.

Reference Type: DERIVED

PMID: 32648248 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31783773 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30508189 (View on PubMed)

Other Identifiers

DIA 2011-1

Identifier Type: -

Identifier Source: org_study_id