Methotrexate in the Treatment of Advanced Knee Osteoarthritis With Effusion-synovitis

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicentre randomized placebo-controlled clinical trial aims to evaluate whether methotrexate (MTX) has effects of relieving symptoms and reducing inflammation on advanced knee osteoarthritis (OA) with inflammatory phenotype. Participants will be randomly allocated to either MTX group or placebo group receiving MTX or placebo once a week. The primary outcomes are effusion-synovitis volume measured by magnetic resonance imaging (MRI) and knee pain assessed by visual analogue scale (VAS).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Collaborators: Beijing Hospital; First Affiliated Hospital of Harbin Medical University; Peking Union Medical College Hospital; Peking University People's Hospital; The First Affiliated Hospital of Anhui Medical University; The Second People's Hospital of GuangDong Province; Third Affiliated Hospital, Sun Yat-Sen University; Xuanwu Hospital, Beijing
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Meet the America College of Rheumatology (ACR) criteria for clinical knee OA assessed by a rheumatologist

• Knee pain, visual analogue scale (VAS) pain at least 40mm

• Kellgren-Lawrence(K-L) grade of 2-4

• Physical examination showed signs of inflammation (at least 2 of the following 4 clinical signs of inflammation: warmth around the joint; tenderness around joint margin; articular cavity effusion; swelling of soft tissue around the knee joint)

• MRI evaluated effusion synovitis grade of ≥ 2

• Capable of understanding the study requirements and willing to cooperate with study instructions, and voluntarily sign informed consent

Exclusion Criteria:

• Inflammatory arthritis (such as gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy), systemic lupus erythematosus

• Knee surgery or arthroscopic examinations were performed or planned within one year, Severe valgus knee deformity (angle of genu valgum > 30°) or previous traumatic history

• MRI contraindications

• Intra-articular injection, intramuscular injection or oral glucocorticoid were used within the last 4 weeks

• Other anti-synovitis agents (such as hydroxychloroquine and sulfasalazine) were applied in the past 3 months

• Clinical significant conditions, such as (but not limited to) active malignant tumor, abnormal renal function (assessed by GFR), hepatic abnormalities [active hepatitis B, hepatitis C, abnormal liver function (ALT is more than twice the upper limit)], respiratory diseases (lung infection, pulmonary fibrosis), hematological changes (e.g white blood cell (WBC) count < 4 x 10^9 /L, platelet < 100 x 10^9 /L or hemoglobin < 100 g/L), serious diseases of gastrointestinal, endocrine, heart, nerve or brain assessed by clinical physicians

• Infectious history such as HIV infection

• Hypersensitivity to methotrexate

• Pregnant and Lactating women