Pharmacological Treatment In Osteoarthritis (FABIO)
This study is currently recruiting participants.
Verified July 2012 by Maasstad Hospital
Sponsor:
Maasstad Hospital
Information provided by (Responsible Party):
WeiChing Lee, Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01148043
First received: June 18, 2010
Last updated: July 27, 2012
Last verified: July 2012
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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 2013 |
| Estimated Primary Completion Date: | June 2013 (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
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: | July 27, 2012 |
| 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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013