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OpenTrials
Completed

NCT Number: NCT01148043

Pharmacological Treatment In Osteoarthritis

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Admiraal de Ruyter Hospital, Goes, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

200 mg capsule, 2 capsules QD for 24 weeks.

Other names: Plaquenil

cellulose

Drug

capsule, 2 capsules QD for 24 weeks

Other names: placebo

Primary outcomes

  1. Pain intensity measured by 100 mm Visual Analog Scale (VAS)

    Time frame: 24 weeks

Secondary outcomes

  1. Hand function measured by Arthritis Impact Measurement Scales 2 short form (AIMS2-SF) and Australian/Canadian Osteoarthritis Hand Index (AUSCAN)

    Time frame: 6, 12 and 24 weeks

  2. Pain intensity measured by 100 mm VAS

    Time frame: 6, 12 weeks

  3. Radiological progression measured by the anatomical lesion progression system from Verbruggen et al.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Maasstad Hospital

Other

Registry information

Acronym: FABIO

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 22, 2010
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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