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Farmacologische Behandeling in Osteoarthritis.


- candidate number8142
- NTR NumberNTR2378
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jun-2010
- Secondary IDsNL32030.101.10 CCMO
- Public TitleFarmacologische Behandeling in Osteoarthritis.
- Scientific TitlePharmacological Treatment in Osteoarthritis.
- ACRONYMFABIO
- hypothesisHydroxychloroquine is effective in reducing pain and improving handfunction in patients with hand osteoarthritis.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hands
- Inclusion criteria1. Age >= 40 years;
2. Primary hand OA according to the ACR classification;
3. Heberden or Bouchard nodule or Kellgren-Lawrence grade 1, 2 or 3 changes in >= 2 symptomatic joints;
4. Pain in the dominant hand >= 12 months;
5. Use of an NSAID for >= 1 episode of pain;
6. Written informed consent.
- Exclusion criteria1. Secondary hand OA, e.g. hemochromatose, rheumatoid arthritis, posttraumatic;
2. Kellgren-Lawrence grade 4 OA;
3. Use of hydroxychloroquine within 3 months before entering the study;
4. Use of NSAIDs or corticosteroids within 7 days before entering the study;
5. Retinopathy;
6. Myasthenia gravis;
7. Known allergy or hypersensitivity for hydroxychloroquine.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2010
- planned closingdate31-dec-2011
- Target number of participants200
- InterventionsHydroxychloroquine sulphate 400 mg QD for 24 weeks, compared to placebo (randomised, double blind; approximately 100 patients per arm).
- Primary outcomePain intensity at week 24 (100 mm VAS).
- Secondary outcome1. Hand function at week 24 (AUSCAN and AIMS2-SF);
2. Pain intensity at week 6 and 12;
3. Radiological progression of anatomical lesions by week 24.
- Timepoints0, 6, 12, 24 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES W.C. Lee
- CONTACT for SCIENTIFIC QUERIES N.M. Basoski
- Sponsor/Initiator Maasstad Hospital
- Funding
(Source(s) of Monetary or Material Support)
Maasstad Hospital
- PublicationsN/A
- Brief summaryOsteoarthritis 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, placebo-controlled trial with hydroxychloroquine in hand osteoarthritis.
- Main changes (audit trail)
- RECORD14-jun-2010 - 3-jul-2010


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