Pharmacological Treatment In Osteoarthritis

Osteoarthritis Clinical Trial

— FABIO  

Official title:

Pharmacological Treatment In Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148043
• Other study ID #: NL32030.101.10
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2010
• Last updated: April 10, 2015
• Start date: July 2010
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Maasstad Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Hydroxychloroquine
200 mg capsule, 2 capsules QD for 24 weeks.
• cellulose
capsule, 2 capsules QD for 24 weeks

Locations

Country	Name	City	State
Netherlands	Admiraal de Ruyter Hospital	Goes
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Maasstad Hospital	Rotterdam
Netherlands	Sint Franciscus Gasthuis	Rotterdam
Netherlands	Vlietland Hospital	Schiedam
Netherlands	ZorgSaam Zeeuws-Vlaanderen	Terneuzen

Sponsors (1)

Lead Sponsor	Collaborator
Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity measured by 100 mm Visual Analog Scale (VAS)		24 weeks	No
Secondary	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	No
Secondary	Pain intensity measured by 100 mm VAS		6, 12 weeks	No
Secondary	Radiological progression measured by the anatomical lesion progression system from Verbruggen et al.		24 weeks	No