ISRCTN77854383已完成3 期
Pain Reduction with Oral Methotrexate in knee Osteoarthritis: a pragmatic phase III trial of Treatment Effectiveness
niversity of Leeds (UK)0 个研究点目标入组 155 人开始时间: 2013年10月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
研究概览
简要总结
2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25872649 protocol 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39074374/ (added 30/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 25/08/2016:
- •1. Fulfil clinical American College of Rheumatology (ACR) Criteria for knee OA
- •2. Knee pain on most days in the last 3 months
- •3. Insufficient pain relief from, inability to tolerate, or contra-indication to oral and/or topical Non-steroidal anti-inflammatory drugs (NSAIDs) and/or opioids and/or Paracetamol. Moderate to severe pain of the signal knee as defined by a score of =40mm on a Visual analogue scale (VAS) (0-100mm) using the question On average, how would you rate your knee pain during the last 3 months?”
- •4. Knee pain is the predominant pain condition
- •5. Patient able to identify a ‘signal’ painful knee (either the most painful knee or selected from equally painful knees)
- •6. A radiograph (X-Ray) of the signal knee within the last 2 years, with changes consistent with tibio-femoral OA
- •7. No change in the average weekly dose of oral/topical analgesics (including NSAIDs and Paracetamol) for at least 4 weeks
- •8. Has used chondroitin or glucosamine for at least 3 months with no change to the average weekly dose, is not using, or is willing to stop using if recently started
- •9. All male and female participants biologically capable of having children must agree to use a reliable method of contraception for the duration of the study and 24 weeks after the end of the study period. Acceptable methods of contraception are surgical sterilisation, oral, implantable or injectable hormonal methods, intrauterine devices or barrier contraceptives. If female and have potential for child bearing then a negative pregnancy test must be performed prior to starting treatment
- •10. The patient must be able to adhere to the study visit schedule and other protocol requirements
- •11. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
- •12. All patients must have had a chest radiograph (X-Ray) within the last 6 months
- •13. Aged = 18 years
- •Previous inclusion criteria:
- •1. Fulfil clinical ACR Criteria for knee OA.
- •2. Knee pain on most days in the last 3 months.
- •3. Insufficient pain relief from, inability to tolerate, or contra-indication to oral and/or topical NSAIDs and/or opioids. 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??.
- •4. Knee pain is the predominant pain condition.
- •5. Patient able to identify a ?signal? painful knee (either the most painful knee or selected from equally painful knees).
- •6. A previous radiograph (X-Ray) of the signal knee with changes consistent with tibiofemoral OA.
- •7. No change in the average weekly dose of oral/topical analgesics (including NSAIDs) for at least 4 weeks.
- •8. Has used chondroitin or glucosamine for at least 3 months with no change to the average weekly dose, is not using or is willing to stop using if recently started.
- •9. 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 MTX. If female and have potential for child bearing then a negative pregnancy test must be performed prior to starting treatment.
- •10. The patient must be able to adhere to the study visit schedule and other protocol requirements.
- •11. The patient must be capable of giving
排除标准
- •Current exclusion criteria as of 25/08/2016:
- •1. The presence of any inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy, previous diagnosis of pseudogout in target joint with proven crystals on joint aspiration or elevated CRP at time of knee arthritis flare) or fibromyalgia.
- •2. Use of intra-articular (IA) hyaluronic acid in the signal knee within the 4 months preceding enrolment in the study.
- •3. Use of IA, IM or oral corticosteroids in the 3 months preceding enrolment.
- •4. Use of other anti-synovial agents (e.g. hydroxychloroquine or sulphasalazine) in the 2 months preceding the study.
- •5. Significant knee injury or any knee surgery within the 6 months preceding enrolment in the study.
- •6. A history of partial or complete joint replacement surgery in the signal knee at any time, listed for knee surgery, or anticipating knee surgery during the study period.
- •7. Commencement of physiotherapy or non-pharmacological knee OA treatment in the 2 months preceding the study.
- •8. The presence of non-OA causes of pain in the signal knee e.g. referred hip pain, osteonecrosis.
- •9. Women who are pregnant, breast-feeding, or men or women planning pregnancy within 18 months after screening (i.e. approximately 6 months following last study medications).
- •10. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- •11. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral disease, or active current infection.
- •12. Uncontrolled disease states, such as moderate/severe asthma, Chronic Obstructive Pulmonary Disease (COPD) or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, or recurrent infections.
- •13. Unwilling to keep alcohol intake to below the recommended maximum daily limit during the trial (2 units per day for women, 3 units per day for men).
- •14. Planned need for live vaccination during 12 months of study (e.g. for foreign travel) with exception of Zostavax® which is permissible.
- •15. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.
- •16. Melanoma, squamous cell carcinoma or non-skin cancer in the past 3 years.
- •17. Intolerance to lactose.
- •18. Significant haematological or biochemical abnormality
- •18.1. Haemoglobin =<8.5 g/dL
- •18.2. WCC =<3.5 x 109/L
- •18.3. Neutrophils =<1.5 x 109/L
- •18.4. Platelets =<100 x 109/L
- •18.5. ALT >2 times ULN for the laboratory conducting the test.
- •18.6. Creatinine > 1.5 times ULN for the laboratory conducting the test
- •18.7. eGFR <30ml/minute
- •Subjects with the following contra-indications to MRI scanning will not be included in the MRI substudy but may still be enrolled into the main study:
- •1. Pacemakers
- •2. Surgical clips within the head
- •3. Certain inner ear implants
- •4. Neuro-electrical stimulators
- •5. Metal fragments within the eye or head
- •Previous exclusion criteria:
- •1. The presence of any inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriasis, psoriatic arthritis, seronegative spondylarthropathy) or fibromyalgia.
- •2. Use of intra-articular (IA) hyaluronic acid in the signal knee within the 4 months preceding enrolment in the study.
- •3. Use of IA, IM or oral corticosteroids in the 3 m
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