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The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.
Osteoarthritis is the most common joint disease, most frequently involving the hands, resulting in pain, stiffness and loss of hand function. At present, there is no option to prevent the onset or the progression of hand osteoarthritis (OA). It is believed that inflammation plays an important role in the pathogenesis of OA and that anti-inflammatory drugs might be an effective treatment for OA. Anti-malarial agents like chloroquine and hydroxychloroquine are potential anti-inflammatory drugs and hydroxychloroquine has already proven to be an effective suppressor of inflammation in rheumatoid arthritis. Several previous studies with hydroxychloroquine in hand OA also showed a possible effect on pain and inflammation, but these studies were mostly retrospective with a small number of patients. This is the first prospective, randomised, placebo-controlled study to determine the effect of hydroxychloroquine in hand osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Hydroxychloroquine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 200 mg capsule, 2 capsules QD for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity measured by 100 mm Visual Analog Scale (VAS) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hand function measured by Arthritis Impact Measurement Scales 2 short form (AIMS2-SF) and Australian/Canadian Osteoarthritis Hand Index (AUSCAN) | 6, 12 and 24 weeks | |
| Pain intensity measured by 100 mm VAS | 6, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalja M Basoski, MD | Maasstad Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Admiraal de Ruyter Hospital | Goes | Netherlands | ||||
| Maasstad Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29125901 | Derived | Lee W, Ruijgrok L, Boxma-de Klerk B, Kok MR, Kloppenburg M, Gerards A, Huisman M, Hazes M, de Sonnaville P, Grillet B, Weel A, Basoski N. Efficacy of Hydroxychloroquine in Hand Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2018 Sep;70(9):1320-1325. doi: 10.1002/acr.23471. Epub 2018 Aug 12. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D002482 | Cellulose |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| cellulose | Drug | capsule, 2 capsules QD for 24 weeks |
|
|
| Radiological progression measured by the anatomical lesion progression system from Verbruggen et al. | 24 weeks |
| Rotterdam |
| 3079DZ |
| Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Sint Franciscus Gasthuis | Rotterdam | Netherlands |
| Vlietland Hospital | Schiedam | Netherlands |
| ZorgSaam Zeeuws-Vlaanderen | Terneuzen | Netherlands |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |