Pharmacological Treatment In Osteoarthritis
FABIO
1 other identifier
interventional
200
1 country
6
Brief Summary
The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2010
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 13, 2015
April 1, 2015
3.9 years
June 18, 2010
April 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity measured by 100 mm Visual Analog Scale (VAS)
24 weeks
Secondary Outcomes (3)
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
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
Study Arms (2)
Placebo
PLACEBO COMPARATORHydroxychloroquine
EXPERIMENTALInterventions
200 mg capsule, 2 capsules QD for 24 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Admiraal de Ruyter Hospital
Goes, Netherlands
Maasstad Hospital
Rotterdam, 3079DZ, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sint Franciscus Gasthuis
Rotterdam, Netherlands
Vlietland Hospital
Schiedam, Netherlands
ZorgSaam Zeeuws-Vlaanderen
Terneuzen, Netherlands
Related Publications (1)
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.
PMID: 29125901DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalja M Basoski, MD
Maasstad Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pharmacist
Study Record Dates
First Submitted
June 18, 2010
First Posted
June 22, 2010
Study Start
July 1, 2010
Primary Completion
June 1, 2014
Study Completion
September 1, 2014
Last Updated
April 13, 2015
Record last verified: 2015-04