Refractory inflammatory hand osteoarthritis Musculoskeletal Diseases Arthropathies
Conditions
Interventions
Arm 1:
1. Capsules body weight adapted to pharmaceutical package (30 - 49 kg one capsule with 200 mg HCQ as daily single dose
2. 50 ? 64 kg one capsule with 200 mg HCQ
Sponsors
Charité - University of Medicine, Berlin (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women from 40 to 80 years 2. Presence of clinical hand OA according to American College of Rheumatology (ACR) criteria 3. Conforming to the ACR criteria for hand OA with recent X ray, dating less than 6 months ago, X ray of the hands showing radiological signs of digital OA in one or more joints as defined by grades 2 or higher, per Kellgren and Lawrence scale or alternatively using the Kallman method or alternativly using the Verbruggen Score; 4. Symptomatic digital OA with more than three finger joints for more than 3 months (at least every other day) despite taking analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) 5. Pain above 35 mm as evaluated by the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) -Visual Analogue Scale( VAS) (0 - 100 mm) 6. Function as co-primary clinical outcome with = 9 using the AUSCAN LK function subscale, or = 225 F (out of maximum of 800) on the AUSCAN VA function subscale
Exclusion criteria
Exclusion criteria: 1. Patients who have already been treated with HCQ 2. Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain 3. Patients suffering or having suffered from secondary OA after one of the following diseases (e.g. infectious arthritis, acromegaly, ochronosis, haemochromatosis, gout, etc.) or inflammatory joint diseases 4. Any unstable medical condition which would put the patient at an unacceptable risk 5. Planned Surgery 6. Local injection with glucocorticoids or other medications within the previous three months 7. Oral glucocorticoids 8. Presence of retinopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Australian-Canadian OA Index (AUSCAN, German version) for pain, and hand disability as co-primary clinical outcome at week 52 2. Radiographic co-primary endpoint: Radiographic progression assessed by the Kallman Score at week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy of HCQ with respect to AUSCAN at week 26 to patient?s global assessment of disease activity, patient?s assessment of stiffness, and physician?s global assessment of disease activity at week 26, 52 2. To compare pain, functioning, disability, quality of life, patient-acceptable symptoms and health (HAQ, SF-36, SACRAH, FiHOA, AUSCAN, Backman score, etc.) week 0, 26, 52 3. To assess and to compare the inflammatory status using the following parameters: joint pain and joint swelling, night pain, morning stiffness, local erythema/redness, CRP - and ESR - levels from baseline to week 26, 52 4. To compare cumulative dosage of consumption per week of standard therapy (NSAIDs, COXibs) 5. Assessment of safety: Safety and tolerability of HCQ with reports on adverse event (AE) and serious advere event (SAE) 6. The eye examination will be performed by an ophthalmologist (baseline and every 6 months) | — |
Countries
Germany
Outcome results
None listed