Improvement in Function Clinical Trial
— Hand OA & MTXOfficial title:
Methotrexate in Hand Osteoarthritis
| Verified date | August 2020 |
| Source | University of Alexandria |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently
exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the
release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease
synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.
The aim of the present study is to assess the efficacy of MTX in decreasing pain and
inflammation in symptomatic hand OA.
Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical
and radiographic criteria of primary knee OA with hand pain, [>4 on the 24-hour average pain
severity scale (0-10) using mean of daily ratings from week preceding randomization] for > 14
days/month during 3 consecutive months preceding enrollment will be included in this
randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria
were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=60) or placebo (n=60)
together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain
will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment
will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID
drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be
detected by ultrasound imaging.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | March 11, 2020 |
| Est. primary completion date | March 11, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - primary knee osteoarthritis - persistent pain - synovitis Exclusion Criteria: - rheumatoid arthritis - gout and pseudogout - traumatic arthritis - other secondary arthritis - renal disease - liver disease |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of Medicine | Alexandria |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alexandria |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | safety and tolerability | Safety and tolerability to treatment will be assessed at each visit. Safety will be assessed by identifying adverse events using open-ended questions and a checklist including common oral methotrexate side effects, physical examination and by laboratory assessment including complete blood picture and liver enzymes. Adverse events will be collected at each visit and up to 28 weeks. | 28 weeks | |
| Primary | pain reduction | The primary outcome will be pain reduction at 28 weeks compared to baseline using a Visual Analogue Pain Scale (VAS) 0-100 mm. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline. | 28 weeks | |
| Secondary | physical function improvement Functional assessment | Improvements in physical functioning McMaster Universities Osteoarthritis Index (WOMAC) subscores for pain, stiffness and function , the patient global assessment of the severity of knee OA measured on a 0-100 mm VAS. The physician-reported disease activity VAS was also recorded. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline. | 28 weeks |