NOR-DMARD: The Norwegian Antirheumatic Drug Register

Sponsor

Diakonhjemmet Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT01581294

Collaborator

University Hospital of North Norway (Other), St. Olavs Hospital (Other), Lillehammer Hospital for Rheumatic Diseases (Other), Vestre Viken Hospital Trust (Other), Helse Forde (Other)

15,000

Enrollment

Locations

464

Duration (Months)

2500

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

15000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2050

Anticipated Study Completion Date :

Dec 1, 2050

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

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 [3, 6, 9, 12, 18, 24, 36, 48, 60 months]
Utility instrument
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 [12, 24, 36, 48, 60 months]
Radiographic progression
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vestre Viken HF Drammen Hospital	Drammen	Buskerud	Norway	3004
2	Lillehammer Hospital for Rheumatic Diseases	Lillehammer	Oppland	Norway	2609
3	Førde Hospital	Førde	Sogn Og Fjordane	Norway	6807
4	St. Olavs Hospital	Trondheim	Sør-Trøndelag	Norway	7006
5	University Hospital of Northern Norway	Tromsø	Troms	Norway	9038
6	Diakonhjemmet Hospital	Oslo		Norway	0319