Hand OA AND Methotrexate Use (Hand OA & MTX)

University of Alexandria

Status: Terminated

Conditions: Reduction of Inflammation; Reduction in Pain; Improvement in Function

Treatments: Drug: 25mg/week oral placebo tablets; Drug: 25 mg/week oral methotrexate tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01927484

alexmed1391963211975

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary knee osteoarthritis
• persistent pain
• synovitis

Exclusion criteria

• rheumatoid arthritis
• gout and pseudogout
• traumatic arthritis
• other secondary arthritis
• renal disease
• liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

2 participants in 2 patient groups, including a placebo group

methotrexate

Experimental group

Description:

25mg oral methotrexate tablets

Treatment:

Drug: 25 mg/week oral methotrexate tablets

placebo

Placebo Comparator group

Description:

25 mg/week placebo tablets

Treatment:

Drug: 25mg/week oral placebo tablets