Painful osteoarthritis of the knee joint. MedDRA version: 9.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis
Conditions
Interventions
Product Name: methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5mg-
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Knee pain on most days in the last 3 months. 2. Insufficient pain relief from, or inability to tolerate NSAIDs and/or opioids. 3. Patient able to identify a predominantly painful knee (the signal knee). 4. Moderate to severe pain of the signal knee as defined by a score of =40mm on a VAS (0-100mm) using the question “On average, how would you rate your knee pain during the last 3 months?” 5. Fulfil clinical ACR Criteria for knee OA. 6. A previous radiograph (X-Ray) of the signal knee with changes consistent with osteoarthritis. 7. Men and women must use adequate birth control measures (e.g. abstinence, oral contraceptives, Intra-uterine device, barrier method with spermicide, or surgical sterilisation) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion or dose of methotrexate. If female and have potential for child bearing then a negative pregnancy test must be performed prior to starting treatment. 8. The patient must be able to adhere to the study visit schedule and other protocol requirements. 9. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.1. The presence of any rheumatic diseases that could be responsible for secondary osteoarthritis. 2. Use of intra-articular hyaluronic acid in the signal knee within the 6 months preceding enrolment in the study 3. The use of oral, parenteral, intra-articular or intra-muscular steroids in the 2 months preceding enrolment into the study 4. Knee injury, diagnostic arthroscopy or knee surgery within the 3 months preceding enrolment in the study 5. The presence of non-OA causes of pain in the signal knee, e.g. referred hip pain, osteonecrosis. 6. Women who are pregnant, nursing, or men or women planning pregnancy within 12 months after screening (i.e. approximately 6 months following last study medications). 7. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer. 8. Significant haematological or biochemical abnormality a. Haemoglobin ?8.5 g/dL b. WCC ?3.5 x 109/L c. Neutrophils ?1.5 x 109/L d. Platelets ?100 x 109/L e. ALT ?2 times ULN for the laboratory conducting the test. f. Creatinine > 1.5 times ULN for the laboratory conducting the test 9. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. 10. Intake of alcohol above the recommended government guidelines (2 units per day for women, 3 units per day for men). 11. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary outcome: Change in WOMAC pain score at 24 weeks (Western Ontario and McMasters Universities Index) To judge the effectiveness of methotrexate at reducing pain in the osteoarthritic knee joint after 24 weeks of treatment, by reducing synovitis in the joint.;Secondary Objective: 1) Changes on ultrasound scan at baseline and 24 weeks. Ultrasound images will be scored for synovitis. 2) Change in OAQoL score (osteoarthritis quality of life score) 3) Change in HADS score (hospital anxiety and depression score) 4) Change in other WOMAC subscales (stiffness and function) 5) Change in West Haven-Yale Multidimensional Pain Inventory scores ;Primary end point(s): The end points are defined as: • Completion of 24 weeks in the study • Withdrawal due to any reason | — |
Countries
United Kingdom
Outcome results
None listed