Pharmacological Treatment In Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-09-30

Brief Summary

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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

cellulose

Intervention Type DRUG

capsule, 2 capsules QD for 24 weeks

Hydroxychloroquine

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

200 mg capsule, 2 capsules QD for 24 weeks.

Interventions

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Hydroxychloroquine

200 mg capsule, 2 capsules QD for 24 weeks.

Intervention Type DRUG

cellulose

capsule, 2 capsules QD for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Plaquenil placebo

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No