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Pharmacological Treatment in Hand Osteoarthritis

Pharmacological Treatment in Hand Osteoarthritis - FABIO

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38184
Enrollment
200
Registered
2010-04-15
Start date
2010-09-16
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gewrichtaandoening degenerative arthritis degenerative joint disease

Interventions

Hydroxychloroquine 400 mg or placebo capsule QD for 24 weeks.

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 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

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 outcomes

Primary

MeasureTime frame
Pain intensity at week 24 (100 mm VAS) compared to baseline

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)