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Pharmacological Treatment In Osteoarthritis (FABIO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148043
First Posted: June 22, 2010
Last Update Posted: April 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
WeiChing Lee, Maasstad Hospital
  Purpose
The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.

Condition Intervention Phase
Osteoarthritis Drug: Hydroxychloroquine Drug: cellulose Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Treatment In Osteoarthritis

Resource links provided by NLM:


Further study details as provided by WeiChing Lee, Maasstad Hospital:

Primary Outcome Measures:
  • Pain intensity measured by 100 mm Visual Analog Scale (VAS) [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • 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 ]
  • Pain intensity measured by 100 mm VAS [ Time Frame: 6, 12 weeks ]
  • Radiological progression measured by the anatomical lesion progression system from Verbruggen et al. [ Time Frame: 24 weeks ]

Enrollment: 200
Study Start Date: July 2010
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: cellulose
capsule, 2 capsules QD for 24 weeks
Other Name: placebo
Experimental: Hydroxychloroquine Drug: Hydroxychloroquine
200 mg capsule, 2 capsules QD for 24 weeks.
Other Name: Plaquenil

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148043


Locations
Netherlands
Admiraal de Ruyter Hospital
Goes, Netherlands
Maasstad Hospital
Rotterdam, Netherlands, 3079DZ
Erasmus Medical Center
Rotterdam, Netherlands
Sint Franciscus Gasthuis
Rotterdam, Netherlands
Vlietland Hospital
Schiedam, Netherlands
ZorgSaam Zeeuws-Vlaanderen
Terneuzen, Netherlands
Sponsors and Collaborators
Maasstad Hospital
Investigators
Principal Investigator: Natalja M Basoski, MD Maasstad Hospital
  More Information

Responsible Party: WeiChing Lee, pharmacist, Maasstad Hospital
ClinicalTrials.gov Identifier: NCT01148043     History of Changes
Other Study ID Numbers: NL32030.101.10
First Submitted: June 18, 2010
First Posted: June 22, 2010
Last Update Posted: April 13, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents