Methorexate and Knee Osteoarthritis

University of Alexandria

Status and phase: Completed; Phase 4

Conditions: Pain Reduction; Physical Function Improvement

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04326894

alexmed1391963211966

Details and patient eligibility

About

Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA.

128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores.

Keywords:

methotrexate knee osteoarthritis inflammation pain reduction physical funtion

Enrollment: 128 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary knee osteoarthritis
• synovitis
• pain

Exclusion criteria

• other inflammatory conditions
• hepatic insufficiency
• renal insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

128 participants in 2 patient groups, including a placebo group

Methotrexate

Experimental group

Description:

25mg oral MTX 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