A 2-year, European Multicentre Study to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis (APPROACH)
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|ClinicalTrials.gov Identifier: NCT03883568|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : April 4, 2019
Rationale: Despite a large and growing disease burden in osteoarthritis (OA), many pharmaceutical companies have abandoned OA drug development. This is mainly due to the lack of appropriate outcome measures that can robustly identify patients that can benefit from a specific therapy. Different phenotypes of OA may benefit from different types of treatment. Therefore, novel markers to identify selected phenotypes of osteoarthritis may encourage drug development.
Objective: To prospectively describe in detail pre-identified progressing phenotypes of patients with knee OA by use of conventional and novel clinical, imaging, and biochemical (bio)markers, and to validate and refine a predictive model for these (and new) progressing phenotypes based on these markers.
Study design: APPROACH is an exploratory, European, five-centre, 2-year prospective follow-up, cohort study, with extensive measurements. In this study patients are treated according to regular care by their own physician with no study related treatment prescribed. Study related diagnostic and/or monitoring procedures are applied to the patients.
Study population: Patients with tibiofemoral knee osteoarthritis, according to the clinical ACR classification criteria, pre-identified based on demographic (e.g. age), clinical (e.g. Pain NRS) and tissue structure (e.g. radiographic joint space width) parameters.
Main study parameters/endpoints: Joint tissue structure based on radiographs, MRI, and biochemical (bio)markers as well as symptoms (pain, function) and quality of life by questionnaires.
Secondary parameters: A multitude of (novel and conventional) clinical, imaging, and biochemical parameters related to osteoarthritis.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will not have any direct benefit from their participation in this study other than that their OA is maximally diagnosed and followed in detail for up to 2 years (screening, baseline, 6 months, 12 months, 24 months).
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A 2-year Multicentre, EU, Exploratory Study Without Therapeutic Benefit in Patients With Knee Osteoarthritis to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis by Use of Clinical, Imaging, and Biochemical (Bio)Markers.|
|Actual Study Start Date :||January 19, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||June 30, 2021|
- OA structural progression of the index knee [ Time Frame: over two years ]radiographic joint space width in mm
- OA pain progression of the index knee [ Time Frame: over two years ]increase in points in Knee Osteoarthritis Outcome Score for pain (0-100; 0 worst, 100 best condition)
- OA progression of the index knee [ Time Frame: over two years ]structural progression (e.g. cartilage volume on MRI in mm3)
- OA progression [ Time Frame: over two years ]structural progression (biochemical markers in units/ml in blood and urine)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883568
|Contact: Anne Karien Marijnissen, PhD||0031 firstname.lastname@example.org|
|Saint-Antoine hospital, AP-HP||Not yet recruiting|
|Contact: F. Berenbaum, MD, PhD|
|Leiden University Medical Center||Recruiting|
|Contact: G. Kloppenburg, MD, PhD|
|Utrecht, Netherlands, 3584 CX|
|Contact: Anne Karien Marijnissen, PhD 0031 88 7550459 email@example.com|
|Contact: I Haugen, MD, PhD|
|A Coruña, Spain|
|Contact: F. Blanco, MD, PhD|
|Study Director:||Floris PJ Lafeber, PhD||UMC Utrecht|