Pharmacological Treatment In Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.

Detailed Description
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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.

Official Title
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Pharmacological Treatment In Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years Primary hand OA according to the ACR classification Heberden or Bouchard nodule or Kellgren-Lawrence grade 1, 2 or 3 changes in ≥ 2 symptomatic joints Pain in the dominant hand ≥ 12 months Use of an NSAID for ≥ 1 episode of pain Written informed consent Exclusion Criteria: Secondary hand OA, e.g. haemochromatoses, rheumatoid arthritis, posttraumatic Kellgren-Lawrence grade 4 OA Use of hydroxychloroquine within 3 months before entering the study Use of NSAIDs or corticosteroids within 7 days before entering the study Retinopathy Myasthenia gravis Known allergy or hypersensitivity for hydroxychloroquine

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: cellulose<br>* capsule, 2 capsules QD for 24 weeks<br>* Other names: placebo;|
| Experimental: Hydroxychloroquine<br> | Drug: Hydroxychloroquine<br>* 200 mg capsule, 2 capsules QD for 24 weeks.<br>* Other names: Plaquenil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured by 100 mm Visual Analog Scale (VAS) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Radiological progression measured by the anatomical lesion progression system from Verbruggen et al. |  | 24 weeks |