Status:
COMPLETED
Methotrexate in the Treatment of Advanced Knee Osteoarthritis With Effusion-synovitis
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
Peking Union Medical College Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Knee Osteoarthritis
Effusion Synovial
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief 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 (O...
Detailed Description
OA is a common chronic musculoskeletal disease in middle-aged and elderly people, which is characterized by loss of articular cartilage and other structural damage of joints. Currently, there is no ef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT03815448
Start Date
July 18 2019
End Date
December 1 2023
Last Update
February 28 2024
Active Locations (11)
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1
The 1st Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
Beijing Hospital
Beijing, Guangdong, China
3
Zhujiang Hospital
Guangzhou, Guangdong, China, 510280
4
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China