Clinical trial NCT01148043: Pharmacological Treatment In Osteoarthritis
Official title: Pharmacological Treatment In Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Maasstad Hospital
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain intensity measured by 100 mm Visual Analog Scale (VAS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Hand function measured by Arthritis Impact Measurement Scales 2 short form (AIMS2-SF) and Australian/Canadian Osteoarthritis Hand Index (AUSCAN)
timeFrame: 6, 12 and 24 weeks
measure: Pain intensity measured by 100 mm VAS
timeFrame: 6, 12 weeks
measure: Radiological progression measured by the anatomical lesion progression system from Verbruggen et al.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Schiedam
country: Netherlands
facility: Vlietland Hospital
city: Terneuzen
country: Netherlands
facility: ZorgSaam Zeeuws-Vlaanderen
Study officials:
affiliation: Maasstad Hospital
name: Natalja M Basoski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee W, Ruijgrok L, Boxma-de Klerk B, Kok MR, Kloppenburg M, Gerards A, Huisman M, Hazes M, de Sonnaville P, Grillet B, Weel A, Basoski N. Efficacy of Hydroxychloroquine in Hand Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2018 Sep;70(9):1320-1325. doi: 10.1002/acr.23471. Epub 2018 Aug 12.