Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disease activity score
研究概览
简要总结
Compare the efficacy of adding small doses of prednisolone (10 mg) daily to the efficacy of adding one of the available anti TNF in the treatment of methotrexate inadequate responder rheumatoid arthritis patient.
Hypothesis:
Methotrexate + Prednisolone vs. Methotrexate + anti TNF
详细描述
Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints and of the tissues around the joints, as well as in other organs in the body. Early diagnosis of rheumatoid arthritis and early aggressive treatment can help prevent joint damage, deformity and disability.
The management of RA rests on several principles; drug treatment, which comprise disease modifying anti-rheumatic drugs (DMARDS), but also non-steroidal anti-inflammatory drugs (NSAIDs) and glucocorticoids (GCs), as well as non-pharmacological measures, such as physical, occupational and psychological therapeutic approaches, together may lead to therapeutic success. However, the mainstay of RA treatment is the application of DMARDs. Methotrexate (MTX) is the anchor drug in the management of RA and has been used for many decades.
New and highly effective DMARDS have continued to emerge until the most recent years- in particular, biologic agents which target tumor necrosis factor, the interleukin 1 (IL -1) receptor, the IL-6 receptor, B lymphocytes and T cell co-stimulation. Furthermore, treatment strategies have changed during this period, initially by calling for early referral and early institution of DMARD treatment on the basis of respective evidence of clinical efficacy.
The EULAR (EUROPEAN LEAGUE AGAINST RHEUMATISM) recommendations for treatment of rheumatoid arthritis (3) emphasize that treatment should be aimed at reaching the target of remission or low disease activity (DAS 28 score ≤ 3.2) as soon as possible in every patient; as long as the target has not been reached, treatment should be adjusted by frequent (every 1-3 months) and strict monitoring.
MTX (1) should be part of the first treatment strategy in patients with active RA and when MTX contraindications (or intolerance) are present, other DMARDs should be considered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 years or older.
- •Satisfies the 2010 American College of Rheumatology/European League Against Rheumatism Criteria for Rheumatoid Arthritis.
- •Rheumatoid arthritis of < 2 years duration
- •Has active disease at the time of enrollment. (Modified Disease Activity Score ≥ 3.2)
- •Demonstrates functional status of class I, II, or III as defined by American College of Rheumatology revised criteria.
- •Is on methotrexate 25 mg weekly or the maximum tolerated dose, therapy should be for at least 3 months duration and on the highest tolerated dose for the last 4 weeks.
- •Is able and willing to self-inject study drug if assigned to the injectable drug group or have a designee who can do so.
- •Is PPD negative (skin test for TB exposure) or completed ≥1 month of latent TB treatment if PPD ≥ 5 or quantiferon (blood test for TB exposure) positive.
- •Is having normal Chest X-Ray.
- •Is Hepatitis B Negative.
- •Not on NSAID (e.g. Ibuprofen) or receiving the same dose of the same NSAID throughout the study period unless side effects occur
- •All patients in childbearing age should use effective birth control methods
- •Is capable of understanding and signing an informed consent form.
排除标准
- •Received any previous treatment with Tumor Necrosis Factor inhibitor or other biologic treatments for Rheumatoid Arthritis (such as abatacept, rituximab, tocilizumab, or Anakinra).
- •Received any previous treatment with oral corticosteroids (e.g. prednisolone)
- •Has a known or expected allergy, contraindication, or hypersensitivity to the medications tested.
- •Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of, the study, or could preclude the evaluation of the subject's response.
- •Received any of the following within 4 weeks before baseline visit: leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, minocycline, or D-penicillamine
- •Received cyclophosphamide within 6mths before screening visit.
- •Received any live (attenuated) vaccines within 4 weeks before screening visit.
- •Received intra-articular or subcutaneous corticosteroid injection within 4 weeks before screening visit.
- •Received bolus intramuscular/ intravenous treatment with corticosteroids (> 20mg prednisone or equivalent) within 4 weeks before screening visit.
研究组 & 干预措施
Pred + Meth
Prednisolone : 10 mg daily
- Methotrexate : 25 mg/ day
ARM 1 Treatment Arm
干预措施: Pred + Meth (Drug)
Anti TNF + Meth
Etanrcept: 50 mg; Adalimumab: 40 mg; Infliximab: 3mg/kg
- Methotrexate 25 mg per day Control Arm
干预措施: Anti TNF + Meth (Drug)
结局指标
主要结局
Disease activity score
时间窗: 4 months
DAS 28: Disease activity score, is a modification of the original DAS score, it divides disease activity into high, moderate, low disease activity, and remission (High disease activity is DAS28 \>5.1, moderate is DAS28 of \>3.2 to 5.1, low disease activity is DAS28 of 2.6 to 3.2, and remission is DAS28 \<2.6).
次要结局
- HAQ Score(4 months)