Pharmacological Treatment In Osteoarthritis (FABIO)

Maasstad Hospital

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Hydroxychloroquine; Drug: cellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT01148043

NL32030.101.10

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: cellulose

Hydroxychloroquine

Experimental group

Treatment:

Drug: Hydroxychloroquine