Pharmacological Treatment In Osteoarthritis (FABIO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Maasstad Hospital
Sponsor:
Information provided by (Responsible Party):
WeiChing Lee, Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01148043
First received: June 18, 2010
Last updated: March 25, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Treatment In Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Maasstad Hospital:

Primary Outcome Measures:
  • Pain intensity measured by 100 mm Visual Analog Scale (VAS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Pain intensity measured by 100 mm VAS [ Time Frame: 6, 12 weeks ] [ Designated as safety issue: No ]
  • Radiological progression measured by the anatomical lesion progression system from Verbruggen et al. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148043

Contacts
Contact: WeiChing Lee, PharmD +31102912313 LeeW@maasstadziekenhuis.nl
Contact: Natalja M Basoski, MD +31102911806 BasoskiN@maasstadziekenhuis.nl

Locations
Netherlands
Admiraal de Ruyter Hospital Recruiting
Goes, Netherlands
Contact: W Lee         
Principal Investigator: PBJ de Sonnaville, MD         
Maasstad Hospital Recruiting
Rotterdam, Netherlands, 3079DZ
Contact: Natalja M Basoski, MD    +31102911806    BasoskiN@maasstadziekenhuis.nl   
Contact: Weiching Lee, PharmD    +31102912313    LeeW@maasstadziekenhuis.nl   
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: W Lee         
Principal Investigator: JMW Hazes, MD, Prof         
Sint Franciscus Gasthuis Recruiting
Rotterdam, Netherlands
Contact: W Lee         
Principal Investigator: AM Huisman, MD, PhD         
Vlietland Hospital Recruiting
Schiedam, Netherlands
Contact: W Lee         
Principal Investigator: AH Gerards, MD         
ZorgSaam Zeeuws-Vlaanderen Recruiting
Terneuzen, Netherlands
Contact: W Lee         
Principal Investigator: B Grillet, MD         
Sponsors and Collaborators
Maasstad Hospital
Investigators
Principal Investigator: Natalja M Basoski, MD Maasstad Hospital
  More Information

No publications provided

Responsible Party: WeiChing Lee, pharmacist, Maasstad Hospital
ClinicalTrials.gov Identifier: NCT01148043     History of Changes
Other Study ID Numbers: NL32030.101.10
Study First Received: June 18, 2010
Last Updated: March 25, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on September 14, 2014