Clinical trial NCT01581294: The Norwegian Antirheumatic Drug Register
Official title: Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Joint Diseases
Keywords: Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis
Spondyloarthritis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: St. Olavs Hospital
name: Lillehammer Hospital for Rheumatic Diseases
name: Vestre Viken Hospital Trust
name: Helse Forde
First posted: 2012-04-20
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug

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.

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

Primary outcomes:
Secondary outcomes:
measure: Disease Activity Score-28 (DAS28)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Simplified Disease Activity Index (SDAI)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Modified Health Assessment Questionnaire (MHAQ)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Rheumatoid Arthritis Impact of Disease (RAID)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: EuroQol 5-dimensions (EQ-5D) questionnaire
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: 28-Swollen joint count
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: 28-Tender joint count
timeFrame: All follow-up visits
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: C-Reactive Protein (CRP)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
measure: Sharp/van der Heijde score
timeFrame: 12, 24, 36, 48, 60 months
measure: Number of participants with adverse events
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months
measure: Clinical Disease Activity Index (CDAI)
timeFrame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken HF Drammen Hospital
state: Buskerud
city: Lillehammer
country: Norway
facility: Lillehammer Hospital for Rheumatic Diseases
state: Oppland
city: Førde
country: Norway
facility: Førde Hospital
state: Sogn Og Fjordane
city: Trondheim
country: Norway
facility: St. Olavs Hospital
state: Sør-Trøndelag
city: Tromsø
country: Norway
facility: University Hospital of Northern Norway
state: Troms
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Tore K Kvien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.