CTRI/2014/04/004571进行中（未招募）3 期
Prospective, multi-centric, randomized, double-blind, two arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-021 / Humira® in Patients with Active Rheumatoid 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
- •2.Subjects must have ACR(American college of Rheumatology) / EULAR(European league against Rheumatism) diagnostic criteria score >=6
- •3.Subjects must have:
- •a.>=6 swollen joints
- •b.>=6 tender joints and
- •c.CRP >= 10 mg/L
- •4.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
- •5.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.
- •6.If using NSAIDs [except rofecoxib (Vioxxï??) which is not permitted], subjects should have been on a stable dose for at least 4 weeks prior to screening.
- •7.The screening laboratory tests must meet the following criteria:
- •a.Haemoglobin >= 5.0 mmol/L (>=8.0 g/dL).
- •b.WBC >=3.5 x 109/L
- •c.Neutrophils >=1.5 x 109/L
- •d.Platelets >=100 x 109/L
- •e.Serum transaminase <=2 times the upper limit of normal
- •f.Alkaline phosphatase levels <=2 times the upper limit of normal
- •g.Serum creatinine <=150 µmol/L (<=1.7mg/dL)
- •8.Subjects must be able to adhere to the study visit schedule and other protocol requirements.
- •9.Subjects must be literate and capable of giving informed consent, and written consent must have been obtained prior to any study procedures.
- •10.Subjects must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
- •11.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.
- •12.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 adalimumab therapy, e.g., Lyme disease or a rheumatic disease other than RA.
- •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 RA)
- •6.Prior use of DMARDâ??s other than methotrexate.
- •7.Subjects with prior and current use of anakinra or abatacept
- •8.Subjects with autoimmune disease other than RA.
- •9.Subjects must not be on prescription herbal, homeopathic, or ayurvedic medicines, including massage/manipulation therapies for at least 1 month prior to randomization.
- •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 severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- •13.History of congestive heart failure [New York Heart Association class III/IV] or unstable angina.
- •14.History of History or signs of lymphoproliferative disease.
- •15.Psoriatic arthritis, vasculitis, interstitial lung disease, severe extra articular manifestations or other auto-immune diseases except RA
- •16.Major surgery (including joint surgery) within 12 weeks prior to randomization.
- •17.History of serious infection
- •a. Having caused hospitalization within 6 months prior to randomization
- •b.Other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection, or a history of recurrent herpes zoster)
- •18.Pre-existing CNS demyelinating disorders.
- •19.Administration of live or live-attenuated vaccine within 8 weeks of screening.
- •20.Allergy to any of the excipients of adalimumab.
- •21.Tuberculosis
- •a.Active TB
- •b.Subjects who have evidence of latent TB [chest X rays, Mantoux test, QuantiFERON®- TB Gold test and TB tests]
- •c.Subjects currently in close contact with an individual with history of active TB
- •22.History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study.
- •23.Participation in any clinical study of an investigational product within the previous 3 months
- •24.In the opinion of the Investigator, not suitable for participation in the clinical study.
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