Knee Osteoarthritis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Clinical Trial of Methotrexate (MTX) in the Treatment of Advanced Knee Osteoarthritis With Effusion-synovitis
Verified date | February 2024 |
Source | Zhujiang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 215 |
Est. completion date | December 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospital | Beijing | Guangdong |
China | Peking Union Medical College University | Beijing | |
China | Peking University People's Hospital | Beijing | |
China | Xuanwu Hospital Capital Medical University | Beijing | |
China | The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
China | Zhujiang Hospital | Guangzhou | Guangdong |
China | Second People's Hospital of Guangdong Province | Guanzhou | Guangdong |
China | The 1st Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
China | Qingyuan People's Hospital | Qingyuan | Guangdong |
China | The Third Hospital of Shenzhen | Shenzhen | Guangdong |
China | Central People's Hospital of Zhanjiang | Zhanjiang | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhujiang Hospital | Beijing Hospital, Central People's Hospital of Zhanjiang, Peking Union Medical College Hospital, Peking University People's Hospital, Qingyuan City People's Hospital, Shenzhen Third 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 |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effusion-synovitis | Knee effusion-synovitis volume/maximal area at suprapatellar pouch will be measured, and severity will be scored from 0-3 in terms of the estimated maximal distension of the synovial cavity by assessing the amount of intra-articular fluid-equivalent signal on T2-weighted MRI. Effusion at central portion, posterior femoral recess and subpopliteal recess will also be assessed. | 12 months | |
Primary | VAS knee pain | Knee pain will be assessed by a 100mm VAS with terminal descriptors of "no pain" and "worst pain possible". | 12 months | |
Secondary | Infrapatellar fat pad (IPFP) signal intensity alteration | Signal intensity alterations with IPFP was defined as discrete areas of increased signal. Standard deviation of IPFP signal intensity and Clustering Factor was used to represent the signal intensity alteration with IPFP. | 12 months | |
Secondary | Western Ontario and McMaster Universities Index (WOMAC) total score | WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items) and physical function (17 items).The score is higher, the knee function is worse. | 12 months | |
Secondary | Outcome Measures in Rheumatology Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responders | The OMERACT-OARSI consists outcome measures in rheumatology arthritis clinical trials including pain, functional impairment and patient's global assessment. For each of these domains, a response was defined by both relative and an absolute change. | 12 months |
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