Pain Reduction in Osteoarthritis of the knee using oral Methotrexate

Completed

• Conditions: Osteoarthritis of the knee; Musculoskeletal Diseases; Osteoarthritis

• Registration Number: ISRCTN66676866
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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 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
11. Aged 53 - 85 years, either sex

Exclusion Criteria

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:
10.1. Haemoglobin less than or equal to 8.5 g/dL
10.2. White cell count (WCC) less than or equal to 3.5 x 109/L
10.3. Neutrophils less than or equal to 1.5 x 109/L
10.4. Platelets less than or equal to 100 x 109/L
10.5. Alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN) for the laboratory conducting the test
10.6. Creatinine greater than 1.5 times ULN for the laboratory conducting the test
11. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
12. Intake of alcohol above the recommended government guidelines (2 units per day for women, 3 units per day for men)
13. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VAS (0 - 100 mm) pain scores at 24 weeks. VAS pain scores will be measured at baseline and 24 weeks, to assess knee pain within the last 48 hours.

Secondary Outcome Measures

Name	Time	Method
1. Changes on ultrasound scan at baseline and 24 weeks. Ultrasound images will be scored for synovitis and effusion, measured in milimetres.<br>2. Change in Osteoarthritis Quality of Life Questionnaire (OAQoL) score, measured at baseline, 12 and 24 weeks<br>3. Change in Hospital Anxiety and Depression Scale (HADS) score, measured at baseline, 12 and 24 weeks<br>4. Change in Western Ontario and McMasters University Index (WOMAC) pain, function and stiffness subscales , measured at baseline, 12 and 24 weeks<br>5. Change in West Haven-Yale Multidimensional Pain Inventory scores, measured at baseline, 12 and 24 weeks<br>6. Change in VAS pain scores measured at baseline and 12 weeks