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FABIO: Pharmacological Treatment In Osteoarthritis

Sponsor
Maasstad Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01148043
Collaborator
(none)
200
Enrollment
6
Locations
2
Arms
50
Duration (Months)
33.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pharmacological Treatment In Osteoarthritis
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: cellulose
capsule, 2 capsules QD for 24 weeks
Other Names:
  • placebo

    		•
    Experimental: Hydroxychloroquine

    Drug: Hydroxychloroquine
    200 mg capsule, 2 capsules QD for 24 weeks.
    Other Names:
  • Plaquenil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain intensity measured by 100 mm Visual Analog Scale (VAS) [24 weeks]

    Secondary Outcome Measures

    1. 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]

    2. Pain intensity measured by 100 mm VAS [6, 12 weeks]

    3. Radiological progression measured by the anatomical lesion progression system from Verbruggen et al. [24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Admiraal de Ruyter Hospital Goes Netherlands
    2 Maasstad Hospital Rotterdam Netherlands 3079DZ
    3 Erasmus Medical Center Rotterdam Netherlands
    4 Sint Franciscus Gasthuis Rotterdam Netherlands
    5 Vlietland Hospital Schiedam Netherlands
    6 ZorgSaam Zeeuws-Vlaanderen Terneuzen Netherlands

    Sponsors and Collaborators

    • Maasstad Hospital

    Investigators

    • Principal Investigator: Natalja M Basoski, MD, Maasstad Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    WeiChing Lee, pharmacist, Maasstad Hospital
    ClinicalTrials.gov Identifier:
    NCT01148043
    Other Study ID Numbers:
    • NL32030.101.10
    First Posted:
    Jun 22, 2010
    Last Update Posted:
    Apr 13, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Osteoarthritis
    Hydroxychloroquine

    Study Results

    No Results Posted as of Apr 13, 2015