The Norwegian Antirheumatic Drug Register

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01581294
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Diakonhjemmet Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tore K Kvien, MD, PhD
Principal Investigator Affiliation Diakonhjemmet Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOther
Overall Status Recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Joint Diseases
Additional Details

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, 9, 12 months and every 6 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, and annual radiographs of hands and feet in patients with peripheral arthritis. Adverse events data will be systematically recorded, but also retrieved by linkage to other registers.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vestre Viken HF Drammen Hospital, Drammen, Buskerud, Norway

Status

Recruiting

Address

Vestre Viken HF Drammen Hospital

Drammen, Buskerud, 3004

Site Contact

Åse S Lexberg, MD

[email protected]

+4732803000

Lillehammer, Oppland, Norway

Status

Recruiting

Address

Lillehammer Hospital for Rheumatic Diseases

Lillehammer, Oppland, 2609

Site Contact

Knut Mikkelsen, MD

[email protected]

+4761279500

Førde Hospital, Førde, Sogn og Fjordane, Norway

Status

Recruiting

Address

Førde Hospital

Førde, Sogn og Fjordane, 6807

Site Contact

Pawel F Mielnik, MD, PhD

[email protected]

+4757839000

St. Olavs Hospital, Trondheim, Sør-Trøndelag, Norway

Status

Recruiting

Address

St. Olavs Hospital

Trondheim, Sør-Trøndelag, 7006

Site Contact

Erik Rødevand, MD

[email protected]

+4781555850

University Hospital of Northern Norway, Tromsø, Troms, Norway

Status

Recruiting

Address

University Hospital of Northern Norway

Tromsø, Troms, 9038

Site Contact

Synøve Kalstad, MD

[email protected]

+4791507766

Diakonhjemmet Hospital, Oslo, Norway

Status

Recruiting

Address

Diakonhjemmet Hospital

Oslo, , 0319

Site Contact

Elisabeth Lie, MD, PhD

[email protected]

+4722454825

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