Pharmacological Treatment In Osteoarthritis
Overview
- Phase
- Phase 3
- Intervention
- cellulose
- Conditions
- Osteoarthritis
- Sponsor
- Maasstad Hospital
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- Pain intensity measured by 100 mm Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.
Detailed Description
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.
Investigators
WeiChing Lee
pharmacist
Maasstad Hospital
Eligibility Criteria
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
Arms & Interventions
Placebo
Intervention: cellulose
Hydroxychloroquine
Intervention: Hydroxychloroquine
Outcomes
Primary Outcomes
Pain intensity measured by 100 mm Visual Analog Scale (VAS)
Time Frame: 24 weeks
Secondary Outcomes
- 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)
- 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)