Hand osteoarthritis
Conditions
Interventions
Trade Name: Prednisolone
Pharmaceutical Form: Oral solution
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Change in joint pain after 6 weeks assessed by AUSCAN pain subscale; • Change in thumb base pain after 6 weeks assessed by a 100 mm VAS; • Change in physical function after 6 weeks assessed by AUSCAN physical function subscale; • Change in physical function after 6 weeks assessed by FIHOA; • Change in physical function after 6 weeks assessed by HAQ; • Change in patient global assessment after 6 weeks assessed by a 100 mm VAS; • Change in physician global assessment after 6 weeks assessed by a 100 mm VAS; • Change in number of hand joints with pain upon palpation (physical exam) after 6 weeks; • Change in inflammatory ultrasonography signs after 6 weeks; • Change in MRI inflammatory signs after 6 weeks; • Change in quality of life assessed by SF-36 after 6 weeks; • Change in grip strength after 6 weeks; • Fulfilment of OARSI responder criteria(18) after 6 weeks; • Change in pain, physical function, patient and physician global assessment and quality of life after 8 weeks; • Change in pain, physical function, patient and physician global assessment, number of painful joints upon palpation, inflammatory signs at US and MRI, quality of life, grip strength, and fulfilment of OARSI responder criteria after 14 weeks. As exploratory parameters we will collect the following questionnaires: fatigue on a 100 mm VAS (baseline, 6 and 14 weeks), Michigan Hand Outcomes Questionnaire (MHOQ) (baseline, 6 and 14 weeks), the Illness Perception Questionnaire (IPQ) (baseline and 14 weeks), the Coping with Rheumatic Stressors questionnaire (CORS) (baseline and 14 weeks), the Hospital Anxiety Depression Scale (HADS) (baseline) and anchor questions regarding pain, physical function, fatigue and quality of life (after 6 weeks). We will assess hand function using the Moberg Pick Up Test at baseline, 6 and 14 weeks. We will assess hand mobility using different measures, e.g. the modified Kapandji Index, HAMIS and fingertip-to-palm-dist | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.;Secondary Objective: The secondary objectives of this study are to increase our knowledge on synovial inflammation in hand osteoarthritis, e.g. it’s role in pain experience, it’s course over three months and it’s responsiveness to prednisolone. Moreover, we want to gain insight in the differences in sensitivity-to-change of several instruments to assess pain, physical function, and synovitis in patients with hand osteoarthritis.;Primary end point(s): The primary endpoint is the change in digital joint pain after 6 weeks, assessed by a 100 mm VAS.;Timepoint(s) of evaluation of this end point: After 6 weeks. | — |
Countries
Netherlands
Contacts
Public ContactPrincipal investigator
Leiden University Medical Center
Outcome results
None listed