Pharmacological Treatment In Osteoarthritis

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Hydroxychloroquine; Drug: cellulose

• Registration Number: NCT01148043
• Lead Sponsor: Maasstad Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-06-18
• Study First Submitted QC: 2010-06-18
• Study First Posted: 2010-06-22
• Study Start: 2010-07
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	Hydroxychloroquine	-
Placebo	cellulose	-

Primary Outcome Measures

Name	Time	Method
Pain intensity measured by 100 mm Visual Analog Scale (VAS)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Pain intensity measured by 100 mm VAS	6, 12 weeks
Radiological progression measured by the anatomical lesion progression system from Verbruggen et al.	24 weeks
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

Trial Locations

Locations (6)

Sint Franciscus Gasthuis; 🇳🇱 Rotterdam, Netherlands

Vlietland Hospital; 🇳🇱 Schiedam, Netherlands

ZorgSaam Zeeuws-Vlaanderen; 🇳🇱 Terneuzen, Netherlands

Admiraal de Ruyter Hospital; 🇳🇱 Goes, Netherlands

Maasstad Hospital; 🇳🇱 Rotterdam, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands