Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties and safety of prednisolone in hand osteoarthritis: a proof-of-concept study

Phase 3

Completed

• Conditions: 10023213; osteoarthritis

• Registration Number: NL-OMON44904
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-10-04
• Results First Posted: 2019-11-21
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

Patients of either sex with *inflammatory* interphalangeal osteoarthritis, defined as at least 4 osteoarthritic interphalangeal joints (IPJs) with nodes, at least 1 IPJ with soft tissue swelling or erythema and at least 1 IPJ with positive power Doppler signal at US, will be recruited. All patients have to fulfill the American College of Rheumatology (ACR) criteria for hand osteoarthritis. A minimal amount of osteoarthritic digital pain (pain at rest >30 mm on VAS) that fluctuates upon drug administration (worsening by >20 mm on the VAS after NSAID wash out) is required. Patients have to use NSAIDs for digital joint pain. In case of digital pain and thumb base pain, digital pain has to be the most intense.

Exclusion Criteria

Exclusion criteria comprise chronic inflammatory rheumatic disease (such as rheumatoid arthritis or gout), fibromyalgia, use of immunomodulating drugs (such as antimalarials and systemic or local corticosteroids) within 90 days, hyaluronic acid injections in the thumb base within 90 days, pregnancy or breast-feeding during the trial, positive rheumatoid factor or anti-CCP antibodies, psoriasis, blood dyscrasias and coagulation disorders, malignancy (except successfully treated squamous or basal cell skin carcinoma), uncontrolled diabetes mellitus or hypertension, unstable ischemic heart disease, heart failure (New York Heart Association III/ IV), severe pulmonary disease, recent stroke, bone marrow hypoplasia, elevated liver enzyme levels (aspartate transaminase (AST) and/or alanine transaminase (ALT) >=2 times normal value), creatinine clearance <=60 ml/min, latex sensitivity, drug or alcohol abuse in the last year, severe and opportunistic infections, chronic infections.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in digital joint pain after 6 weeks,<br /><br>assessed by a 100 mm VAS.</p><br>