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 algorithm for these (and new…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression of osteoarthritis measured by joint tissue structure based on
radiographs, MRI, and biochemical (bio)markers as well as symptoms (pain,
function) and quality of life by questionnaires.
Secondary outcome
a multitude of (novel and conventional) clinical, maging, and biochemical
parameters related to osteoarthritis.
Background summary
Despite a large and growing disease burden in osteoarthritis (OA), many
pharmaceutical companies have abandoned OA drug development mainly due to the
lack of appropriate outcome measures that can robustly identify patients that
can benefit from a specific therapy.
Study 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 algorithm 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.
Study burden and risks
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).
Patients will stay in the hospital for 4-5 hours per visit (for screening about
30 min) for physical examination, blood draw, MRI scans, radiographs of knees
and hands (only at baseline and 24 months), CT scan of the knee (only at
baseline and 24 months), low radiation whole body CT scan (only at baseline and
24 months), HandScan (only at baseline and 24 months), motion analysis and
performance based tests. They will be asked to fill out questionnaires about
knee, hand and hip osteoarthritis, and about general health and pain. The
patient council in the consortium indicated that the load is acceptable. The
patient council will be involved in the execution of the study.
The assumed risk is minimal for an individual patient and minimal compared to
the contribution to the development of knowledge of their disease. These risks
include minimal events due to blood sampling itself (such as hematoma or
localized bleeding), roentgen exposure by radiographic imaging techniques (with
a minimal increased healthcare risk), and exposure to MRI techniques (without
known risks and without use of contrast agents).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Ambulatory (able to walk unassisted)
2. At least 18 years of age
3. Capable of understanding the study
4. Capable of writing and reading in local language
5. Predominantly tibiofemoral knee osteoarthritis and satisfy the clinical
classification criteria of the American College of Rheumatology (ACR): Knee
pain and three of the following criteria: over 50 years age, less than 30
minutes of morning stiffness, crepitus on active motion, bony tenderness, bony
enlargement, or no palpable warmth.
6. Informed consent obtained as described in section 12.3 of the protocol.
7. Highest probability to progress based on a selection algorithm based on the
following criteria:
- KOOS questionnaire
- BMI (in recording height and weight)
- Pain NRS of the index knee at the moment of the screening visit
- Pain NRS of the index knee during the last week before the screening visit
- Age
- Gender
- KIDA parameters of the index knee, based on standardized weight-bearing
(KIDA) radiograph, measured < 3 months (patients with a JSW < 2 mm of the index
knee will not be included)
Exclusion criteria
8. Not being able to comply to the protocol
9. Participating in a trial with local therapeutic intervention for index knee
OA (pharmaceutical or surgical) or systemic DMOADs or potential DMOADs
treatments for OA at the same time or within the past 6 months or anticipated
in the forthcoming; participation in non-interventional registries or
epidemiological studies is allowed.
10. Surgery of the index knee in the past 6 months (to avoid interferences with
imaging)
11. Scheduled or expected surgery of the index knee in the next 2 years (to
avoid interferences with imaging)
12. Pregnancy (child bearing woman) because of imaging (radiation and MRI,
risks), 13. Predominantly patellar femoral knee OA
14. The following secondary osteoarthritis of the knee: clinically significant
deformities of the lower limbs (varus >10°, valgus >10°), septic arthritis,
inflammatory joint disease, gout, major chondrocalcinosis (pseudogout), Paget*s
disease of the bone, ochronosis, acromegaly, haemochromatosis, Wilson*s
disease, rheumatic symptoms due to malignancies, primary osteochondromatosis,
osteonecrosis, osteochondritis dissecans, haemophilia
15. Generalized pain syndrome, for example fibromyalgia
16. Patients with contra indication to MRI or CT
17. Hip replacement or expected hip replacement within 6 months
18. Self-reported severe spine OA
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61405.041.17 |