A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate.

Glenmark Pharmaceuticals SA0 个研究点目标入组 406 人开始时间: 2011年3月10日最近更新: 2013年2月4日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 406

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Male or female =18 to = 65 years of age at the time of Informed Consent.
•Documented history of RA diagnosed according to the revised (1987) American College of Rheumatology criteria (ACR) for at least 6 months prior to screening.
•Meets ACR functional class I, II or III.
•Active RA defined as patients with:
•6 or more swollen joint counts both at screening (visit 1) and baseline(visit 4),
•6 or more tender/painful joint counts both at screening(visit 1) and baseline
•(visit 4), and
•At least two of the three following criteria:
•i. Rheumatoid Factor positive or Anti CCP positive at screening visit as measured by the central laboratory,
•ii.CRP = 1.2 times upper limit of normal reference range of the central laboratory or ESR >28 mm/hr (by Westergren method) at local laboratory at screening (visit 1)
•iii. Morning stiffness lasting > 45 min for at least 4 weeks prior to informed consent through screening visit 1
•DAS-28 CRP values greater or equal to 4.5 at screening (visit 1)
•Requirements for background RA therapies:
•Methotrexate (MTX):
•Patients must have been on stable or maximum tolerated dose of MTX for at least 12 weeks prior to screening visit (visit 1),
•On a weekly dose of at least 15 mg and not more than 25 mg or Maximum Tolerated Dose (with documented Adverse Drug Reaction at a higher dose) or Maximum approved dose.
•On a stable dose of folic acid supplementation of at least 5 mg per week for at least one week prior to screening (visit 1) and the same must be continued throughout the course of the trial unless dose escalation is required during the course of the study to treat MTX related Adverse Drug Reaction.
•Other DMARDs:
•A four week washout starting at visit 2 will be carried out for eligible patients on Hydroxychloroquine (HCQS) or Sulphasalazine (SSZ). Patients on HCQS should have been on a stable dose of 200-400 mg/day for at least 12 weeks prior to screening visit (visit 1). Patients on SSZ should have been on a stable dose of upto 2 g/day) for at least 4-8 weeks prior to screening visit (visit 1). These patients will complete their washout period while they are on single blind placebo (i.e. during run in period).
•Concomitant use of oral corticosteroids (equivalent to less than or equal to 10mg/day of prednisone) are permitted if doses have been stable (defined as at least 4 weeks prior to screening (visit 1)) and if patient and Investigator is willing to maintain the same dose throughout the run-in and treatment phase.
•A non-steroidal anti-inflammatory drug (NSAID) or selective COX inhibitor is allowed if patient is on stable dose for four weeks prior to randomisation and will be continued on same dose throughout the treatment period.
•Patients should not be treated with complementary/Alternative medicines anytime during the 3 months prior to screening visit. Diet (e.g. nutritional supplements like cod liver oil etc.), acupuncture, aromatherapy, chiropractic and massage are considered as non-pharmacological treatments and are allowed irrespective of the duration of use.
•The patient’s written informed consent to participate in the study.
•Female participants must have a negative serum pregnancy test at
•screening visit. In addition, female of child bearing potential must agree to use at least TWO highly effective methods of contraception. Female patients must agree to have urine

排除标准

•Diagnosis of RA prior to 16 years of age (Juvenile RA).
•Non-degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA (i.e. Chikungunya arthritis, gout,
•pseudogout, chondrocalcinosis, psoriatic arthritis, infectious arthritis, reactive arthritis or spondylitic arthritis).
•Patients with any other autoimmune rheumatic disorders with the exception of Sjogren’s syndrome.
•Patients with first degree relative with immune deficiency.
•Treatment with intraarticular/intravenous/intramuscular injection
•with corticosteroids one month before screening.
•Patients who are on any DMARD other than MTX over the last 3 months (see criteria for HCQS and Sulphasalzine vide supra).
•Patients who have been on Anti TNF a agents or biological modifiers over the last 12 months prior to screening will not be eligible for participation in the study.
•Patients having history of active bacterial infection (or a bacterial infection requiring antibiotics) or active tuberculosis as deemed from medical history.
•History of infection with human immunodeficiency virus and/or active
•hepatitis B or C.
•Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients.
•Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to screening visit or planned during the study.
•Patients who exhibit abnormalities on physical examination or who have abnormal vital signs or clinical laboratory values, unless these abnormalities are judged by the Principal Investigator not to be clinically significant.
•Patients with a history of drug or alcohol abuse or chronic smoking.
•Uncontrolled diabetes mellitus as defined by a HbA1C value = 7.0%.
•Concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s wellbeing e.g., evidence or history of malignancy other than excised basal cell carcinoma or indolent prostate cancer; any clinically significant hematologic, endocrine, cardiovascular (e.g. myocardial infarction within 3 months before visit 1), respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for more than 1 year and is judged by the Investigator not to interfere with the patient’s participation in the study, the patient may be included, with the documented approval of the Investigator or Study Physician.
•QTcB interval of greater than 450 ms in ECG at visit 1, or other ECG abnormalities judged by the investigator to be clinically significant, a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), the use of concomitant medications that prolong the QT/QTc interval.
•History of using any other test drug, one month before the beginning of this trial.
•Women who are pregnant or breast-feeding.
•Patients who in the Investigator’s opinion might not be suitable for the study.
•Patients with a life expectancy of less than 1 year.

研究者

发起方

Glenmark Pharmaceuticals SA

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