Pain Reduction in Osteoarthritis of the knee using oral Methotrexate
ISRCTN | ISRCTN66676866 |
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DOI | https://doi.org/10.1186/ISRCTN66676866 |
Secondary identifying numbers | RR08/8797 |
- Submission date
- 08/12/2010
- Registration date
- 09/05/2011
- Last edited
- 24/06/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Philip Conaghan
Scientific
Scientific
Section of Musculoskeletal Disease
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
Study information
Study design | Single centre open label study |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | Not available in web format, please contact c.y.j.wenham@leeds.ac.uk to request a patient information sheet |
Scientific title | An open label study to assess the effectiveness of oral methotrexate at reducing pain in knee osteoarthritis |
Study acronym | PROM |
Study objectives | Osteoarthritis (OA) is the most common arthritis worldwide and causes significant pain and disability. Current treatments including non-steroidal anti-inflammatory drugs (NSAIDs) and opioids have significant side-effects. There is an urgent need for safe, long-term treatments for pain in OA. Recent imaging studies, in particular magnetic resonance imaging (MRI) have demonstrated that synovitis is very common in OA of the knee and strongly associated with pain. Methotrexate (MTX) is a safe and effective treatment for synovitis with good efficacy and long-term safety in inflammatory arthritides. This 24 week open label study evaluates the effectiveness of methotrexate at pain reduction in knee OA. We also assessed ultrasound-detected synovitis. |
Ethics approval(s) | Leeds (West) Research Ethics Committee approved on the 26th March 2009 (ref: 09/H1307/11) |
Health condition(s) or problem(s) studied | Osteoarthritis of the knee |
Intervention | Oral methotrexate up to 20 mg for 24 weeks. No placebo (open label). |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase IV |
Drug / device / biological / vaccine name(s) | Methotrexate |
Primary outcome measure | 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 | 1. Changes on ultrasound scan at baseline and 24 weeks. Ultrasound images will be scored for synovitis and effusion, measured in milimetres. 2. Change in Osteoarthritis Quality of Life Questionnaire (OAQoL) score, measured at baseline, 12 and 24 weeks 3. Change in Hospital Anxiety and Depression Scale (HADS) score, measured at baseline, 12 and 24 weeks 4. Change in Western Ontario and McMasters University Index (WOMAC) pain, function and stiffness subscales , measured at baseline, 12 and 24 weeks 5. Change in West Haven-Yale Multidimensional Pain Inventory scores, measured at baseline, 12 and 24 weeks 6. Change in VAS pain scores measured at baseline and 12 weeks |
Overall study start date | 31/07/2009 |
Completion date | 31/03/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 30 fully recruited |
Key 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 |
Key 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 |
Date of first enrolment | 31/07/2009 |
Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom
LS7 4SA
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
QA department
Research and Development
34, Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
Website | http://www.leeds.ac.uk/ |
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https://ror.org/024mrxd33 |
Funders
Funder type
University/education
University of Leeds (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/05/2013 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |