Hydroxychloroquine (HCQ) in patients with inflammatory osteoarthritis (OA) of the hands

Phase 3

Completed

• Conditions: Refractory inflammatory hand osteoarthritis; Musculoskeletal Diseases; Arthropathies

• Registration Number: ISRCTN46445413
• Lead Sponsor: Charité - University of Medicine, Berlin (Germany)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25348033 protocol

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-09
• Study Completion: 2018-07-05
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 510

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Australian-Canadian OA Index (AUSCAN, German version) for pain, and hand disability as co-primary clinical outcome at week 52<br> 2. Radiographic co-primary endpoint: Radiographic progression assessed by the Kallman Score at week 52<br>