The Norwegian Antirheumatic Drug Register (NOR-DMARD)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01581294 |
|
Recruitment Status :
Recruiting
First Posted : April 20, 2012
Last Update Posted : August 23, 2022
|
Sponsor:
Diakonhjemmet Hospital
Collaborators:
University Hospital of North Norway
St. Olavs Hospital
Lillehammer Hospital for Rheumatic Diseases
Vestre Viken Hospital Trust
Helse Forde
Information provided by (Responsible Party):
Tore K Kvien, Diakonhjemmet Hospital
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 18, 2012 | ||||||||
| First Posted Date | April 20, 2012 | ||||||||
| Last Update Posted Date | August 23, 2022 | ||||||||
| Study Start Date | April 2012 | ||||||||
| Estimated Primary Completion Date | December 2050 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures | Not Provided | ||||||||
| Original Primary Outcome Measures | Not Provided | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Samples (including serum, plasma and full blood) for biomarker or DNA/RNA discovery and validation will be collected and stored in a freezer at -70 C at visits at baseline and at the 3-month assessment.
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug | ||||||||
| Condition | Inflammatory Joint Diseases | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
15000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 2050 | ||||||||
| Estimated Primary Completion Date | December 2050 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | Norway | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT01581294 | ||||||||
| Other Study ID Numbers | DIA 2011-1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Tore K Kvien, Diakonhjemmet Hospital | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Diakonhjemmet Hospital | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators |
|
||||||||
| Investigators |
|
||||||||
| PRS Account | Diakonhjemmet Hospital | ||||||||
| Verification Date | August 2022 | ||||||||