CTRI/2016/07/007097进行中（未招募）3 期
Prospective, multi-centre, randomized, double-blind,two-arm, parallel group, active-control, comparativeclinical study to evaluate pharmacokinetic, efficacy andsafety of R-TPR-018/ Enbrel® in Patients with ActiveRheumatoid Arthritis on a stable dose of Methotrexate
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males and females, aged 18 to 65, inclusive.
- •2. Diagnosis of Rheumatoid Arthritis according to the criteria based on the revised 2010
- •American College of Rheumatology (ACR)/ European League against Rheumatism
- •(EULAR) classification criteria for Rheumatoid Arthritis.
- •3. Subjects must have ACR/EULAR diagnostic criteria score >=6.
- •4. Subjects must have active disease as defined by:
- •a. >=6 swollen joints
- •b. >=6 tender joints and
- •c. Acute phase reactant values (CRP >8 mg/L or ESR >28 mm/h)
- •5. Subjects must have been on treatment with methotrexate (10 to 25 mg/week) (oral or
- •injectable) for at least 3 months with no break(s) in treatment of more than 2 weeks in
- •total during this period and stable dose between 10 and 25mg/week for at least 4 weeks prior to screening and it is planned that the same dose will continue for the entire duration of the study
- •6. Subjects using oral corticosteroids must have been on a stable dose of up to 10 mg/day prednisolone or equivalent, for at least 4 weeks prior to screening. If currently not using corticosteroids, the subject must have not received corticosteroids for at least 4 weeks prior to screening.
- •7. If using NSAIDs [except rofecoxib (Vioxx®) which is not permitted], subjects should have been on a stable dose for at least 4 weeks prior to screening.
- •8. The screening laboratory tests must meet the following criteria:
- •Haemoglobin >= 5.0 mmol/L (>=8.0 g/dL).
- •WBC >=3.5 x 109/L
- •Neutrophils >=1.5 x 109/L
- •Platelets >=100 x 109/L
- •Serum transaminase <=2 times the upper limit of normal
- •Alkaline phosphatase levels <=2 times the upper limit of normal
- •Serum creatinine <=150 μmol/L (<=1.7mg/dL)
- •9. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
- •10. Subjects must be literate and capable of giving informed consent, and written consent must have been obtained prior to any study procedures.
- •11. Subjects must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
- •12. Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection.
- •13. Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
排除标准
- •1. Pregnant women, nursing mothers or a planned pregnancy within 18 months of randomization.
- •2. Subjects who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
- •3. Subjects who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the etanercept therapy, e.g., Lyme disease or a rheumatic disease other than Rheumatoid
- •4. History within one year prior to randomization of illicit drug use.
- •5. Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept (or any biological treatment of Rheumatoid Arthritis)
- •6. Prior use of disease-modifying anti-rheumatic drugs, other than methotrexate, including hydroxychloroquine, chloroquine, or sulfasalazine, within 4 weeks prior to screening. Patients who discontinued leflunomide and have had successful chelation with 8g of cholestyramine (3 times daily) for 11 days must wait for 4 weeks prior to screening. Patients who discontinued leflunomide and did not have
- •cholestyramine washout must wait for 12 weeks after last dose of leflunomide before randomization.
- •7. Subjects with prior and current use of anakinra or abatacept
- •8. Subjects with autoimmune disease other than Rheumatoid Arthritis.
- •9. Subjects must not be on prescription herbal, homeopathic, ayurvedic or traditional medicines, including massage/manipulation therapies for at least 1 month prior to randomization, Subsequently after study medication administration these treatments will be not be allowed throughout study period.
- •10. Subjects who have a current or past history of chronic infection with Hepatitis B, Hepatitis C, or infection with Human Immunodeficiency Virus-1 or-2 or who have a positive result to the screening test for those infections.
- •11. History or presence of any form of cancer within the 10 years prior to randomization.
- •12. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the subject incapable of participating in the study
- •13. History of congestive heart failure [New York Heart Association class III/IV] or
- •unstable angina.
- •14. History of lymphoproliferative disease including lymphoma or signs suggestive of
- •possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or splenomegaly.
- •15. Presence of psoriatic arthritis, vasculitis, interstitial lung disease, severe extra articular manifestations or other auto-immune diseases (having documented evidence) except rheumatoid arthritis.
- •16. Major surgery (including joint surgery) within 12 weeks prior to randomization.
- •17. History of serious infection, which caused hospitalization within 6 months prior to randomization or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection such as histoplasmosis, or a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment.
- •18. Pre-existing central nervous system demyel
研究者
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