To evaluate the efficacy of 400 mg QD hydroxychloroquine in hand OA patients after 24 weeks of treatment.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gewrichtaandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain intensity at week 24 (100 mm VAS) compared to baseline
Secondary outcome
Hand function at week 24 (AUSCAN and AIMS2-SF) compared to baseline
Pain intensity at week 6 and 12 compared to baseline
Radiographic progression at week 24
Background summary
Osteoarthritis is the most common joint disease, most frequently involving the
hands, resulting in pain, stiffness and loss in hand function. At present,
there is no way to prevent the onset or the progression of hand osteoarthritis
(OA). It is believed that inflammation plays a 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
and done with a small number of patients.
Study objective
To evaluate the efficacy of 400 mg QD hydroxychloroquine in hand OA patients
after 24 weeks of treatment.
Study design
Randomised, double blind, placebo controlled study
Intervention
Hydroxychloroquine 400 mg or placebo capsule QD for 24 weeks.
Study burden and risks
2 visits (day 0 and week 24)
2 follow up telephone calls (week 6 and 12)
4 questionnaires (day 0, week 6, 12 and 24)
1 diary
1 radiograph of both hands
Maasstadweg 21
Rotterdam 3079DZ
NL
Maasstadweg 21
Rotterdam 3079DZ
NL
Listed location countries
Age
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 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. hemochromatose, 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
Myastenia Gravis
Known allergy or hypersensitivity for hydroxychloroquine
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019684-11-NL |
| CCMO | NL32030.101.10 |
| OMON | NL-OMON25343 |