DIGItal Cohort Osteoarthritis Design
Ключови думи
Резюме
Описание
Primary objective To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 6 years of follow-up.
Secondary objectives To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up.
To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up.
To investigate whether clinical changes and radiographic structural changes are associated or correlated between inclusion and 3 years of follow-up or between inclusion and 6 years of follow-up To investigate whether clinical status and radiographic alterations are correlated at inclusion To determine whether hand OA is associated with other OA at other sites or with other hand diseases (carpal tunnel syndrome, tendinitis) To evaluate frequency of erosive hand OA among the whole hand OA cohort at inclusion, at 3 and 6 years of follow-up To identify clinical, biological, genetic and imaging factors associated with erosive hand OA (versus non erosive hand OA) at inclusion or during the follow up (3 and 6 years) To investigate predictive clinical, biological, genetic and imaging factors of clinical or radiographic aggravation after 3 or 6 years of follow-up in the erosive hand OA subgroup
Methods : Prospective observational study The study will be proposed to all patients viewed at the out-patient clinic for hand OA which took place in Saint-Antoine Hospital in Rheumatology Department since 2004 (usually 12/week). The investigators plan to include 500 patients in the cohort (5/week).
7 visits (one per year) are planned: M0, M12, M24, M36, M48, M60 and M72. A clinical evaluation of hand OA will be performed at each visit. At visit M0, M36 and M72, hand radiographs and radiographs of other OA localisation (if symptomatic) will be performed.
A blood sample will be taken at inclusion for biomarker studies and genetic investigations.
A blood sample will be taken at M36 and M72 to build a prospective serum collection.
Duration of the study: 8.5 years with 2.5 years of inclusion period Duration of the study for one patient: 6 years Recruitment at the Rheumatology Department of Saint-Antoine Hospital with a multicentric international steering committee
Дати
| Последна проверка: | 06/30/2019 |
| Първо изпратено: | 03/28/2013 |
| Очаквано записване подадено: | 04/09/2013 |
| Първо публикувано: | 04/14/2013 |
| Изпратена последна актуализация: | 07/14/2019 |
| Последна актуализация публикувана: | 07/15/2019 |
| Действителна начална дата на проучването: | 03/31/2013 |
| Приблизителна дата на първично завършване: | 08/31/2022 |
| Очаквана дата на завършване на проучването: | 08/31/2022 |
Състояние или заболяване
Интервенция / лечение
Other: symptomatic and radiographic hand osteoarthritis
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Other: symptomatic and radiographic hand osteoarthritis Patients above 35-years old with symptomatic and radiographic hand osteoarthritis | Other: symptomatic and radiographic hand osteoarthritis GENETIC : Blood sample for genetic analysis will be performed at inclusion in order to built a DNA collection OTHER: Serum samples will be performed at inclusion M0, M36 and M72 for serum biomarkers assessment OTHER : These radiographs will be performed at M0, M36 and M72 |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 35 Years Да се 35 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Patients above 35-years old, having hand OA according to one of the following definitions: - symptomatic hand OA fulfilling ACR criteria on at least 2 joints among proximal interphalangeal, distal interphalangeal joints or 1st interphalangeal joint with Kellgren-Lawrence > 2 - symptomatic thumb base OA with Kellgren-Lawrence > 2 Exclusion Criteria: - Inflammatory rheumatic destructive disorders (psoriatic arthritis, rheumatoid arthritis) - Polyarthritis related to gout or chondrocalcinosis involving hand - Secondary hand OA related to infection or traumatism - Secondary OA related to genetic dysplasia - Pregnancy and feeding |
Резултат
Първични изходни мерки
1. Baseline clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up(AUSCAN VA3.0) [6 years]
Вторични изходни мерки
1. Baseline clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up(AUSCAN VA3.0) [3 years]
2. Kallman score, Verbruggen score, Kellgren-Lawrence grading and OARSI scoring (Altman score) [3 and 6 years]
3. patients above 35 years old with symptomatic and radiographic hand osteoarthritis [6 years]
