An open label study to assess the effectiveness of oral methotrexate at reducing pain in knee osteoarthritis

niversity of Leeds (UK)0 sites30 target enrollmentMay 9, 2011

Overview

No summary available.

Registry

who.int

Start Date

May 9, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds (UK)

•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 greater than or equal to 40 mm on a Visual Analogue Scale (VAS) (0 \- 100 mm) using the question On average, how would you rate your knee pain during the last 3 months?
•5\. Fulfil clinical American College of Rheumatology (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 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
•10\. All patients with pre\-existing lung disease/smokers must have had a chest radiograph (X\-Ray) within the last 6 months

•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 or the use of depo corticosteroid injection within the 6 months preceding enrolment in the study
•3\. Use of intra\-articular corticosteroid injections in the 3 months preceding enrolment
•4\. The use of oral or parenteral steroids in the 2 months preceding the study
•5\. Knee injury or diagnostic arthroscopy within the 6 months preceding enrolment in the study
•6\. A history of knee surgery in the signal knee at any time
•7\. The presence of non\-OA causes of pain in the signal knee, e.g. referred hip pain, osteonecrosis
•8\. 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)
•9\. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half\-lives of the investigational agent, whichever is longer
•10\. Significant haematological or biochemical abnormality: