An open label study to assess the effectiveness of oral methotrexate in reducing pain in knee osteoarthritis - Pain Reduction in Osteoarthritis using oral Methotrexate
- Conditions
- Painful osteoarthritis of the knee joint.MedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritis
- Registration Number
- EUCTR2008-008237-11-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method