CTRI/2024/03/064580招募中3 期
A randomised, double-blind, multicentre study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia® administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis. - NI
Dr. Reddys Laboratories Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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) Patients should provide a written informed consent (as per the local regulations applicable to the study site and general good clinical practice (GCP) guidelines.
- •2) Male or female patient aged greater than or equal to 18 years and less than or equal to 80 years at the time of signing informed consent.
- •3) Patients with moderately to severely active RA for at least 6 months’ duration, defined as per the ACR Criteria, 1987 revision.
- •Active RA is defined as having:
- •SJC greater than or equal to 10 out of the 66 joints count
- •TJC greater than or equal to 12 out of the 68 joints count, and
- •CRP of at least 1.0 mg/dl determined using a highly sensitivity assay.
- •4) Patient must be on MTX and folic acid for at least 3 months prior to the first dose of study drug with the below requirements.
- •o Must have been treated with stable doses of MTX (at least 15 mg/ week; at least 6 mg/ week for patients from other Eastern Asia countries, not exceeding allowed maximum dose in the country-specific label) for at least 4 weeks prior to randomisation.
- •o Patients who cannot tolerate higher dose of MTX should be on stable and tolerable dose of MTX for 4 weeks prior to study entry (there should be documented evidence of intolerance to MTX).
- •o Patients taking MTX must be on a stable dose of folic acid (greater than or equal to 5 mg per week) or equivalent for at least 4 weeks prior to randomisation.
- •5) Patient should not be on cDMARDs other than MTX for at least 4 weeks prior to the first dose of study drug (4 weeks’ prior for azathioprine, sulfasalazine; 8 weeks for hydroxychloroquine and chloroquine; 12 weeks for leflunomide; 24 weeks for cyclophosphamide).
- •6) Patients should not be on bDMARDs: these agents should have been discontinued at least 4 weeks (4 weeks prior for TNF alpha inhibitors; 24 weeks for rituximab; 4 weeks or half of biological half-life for other bDMARDs whichever is longer) prior to the first dose of study drug.
- •7) Patient on glucocorticoids should not be receiving more than 10 mg oral prednisone/ prednisolone or equivalent per day, and those receiving should be using stable dose for at least 6 weeks prior to randomisation.
- •8) For patient receiving non-steroidal anti-inflammatory drugs (NSAIDs) for the last 4 weeks prior to randomisation:
- •a. Should be taking a stable dose NOT higher than the maximum recommended dose for the agent in the Prescribing Information of the country where the study centre is located.
- •b. NSAIDs are allowed except for the 12h before the efficacy scheduled assessment visit (24h for oxicams and other single daily dose or less frequently administered agents); Details of permitted and prohibited medication in the current study has been captured at Section 6.9.
- •9) Women of childbearing potential should have a negative pregnancy test and should agree to use highly effective measures of contraception and not to donate or cryopreserve ova during the course of the study and for at least 6 months after the last dose of the study drug.
- •Male patient permanently sterile by bilateral orchidectomy or agree to use appropriate contraception methods (see list in the Note below) and not to donate or cryopreserve sperm during the study and for at least 6 months after the last dose of study drug.
- •10) Patients should have the ability to comply with all study requirements.
排除标准
- •1 Patients who have received prior treatment with abatacept.
- •2 Patients who have received prior treatment with JAK inhibitors within the last 16 weeks of first dose of study drug administration (e.g. tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib etc.).
- •3 Patients who have received treatment with IV gamma globulin or plasmapheresis within 6 months of randomisation.
- •4 Patients with known contraindication to treatment with abatacept, including, but not restricted to hypersensitivity to abatacept, or any excipients (maltose, monobasic sodium phosphate and sodium chloride).
- •5 Patients who need concomitant RA therapies other than
- •a. MTX with folic acid (at a dose of at least 5 mg per week [or equivalent]) (MTX and folic acid will be kept at a stable dose during the study); Folinic acid at the same dose of folic acid, can be given in place of folic acid if it is allowed by the local label. Patient should take the same folate supplementation throughout the duration of the study.
- •b. NSAIDs at approved doses kept at stable doses during the study;
- •c. Corticosteroids at a maximum daily dose of 10 mg of oral prednisone or equivalent kept stable during the study; or
- •Also, patients who cannot maintain an analgesics-free period of appropriate duration (12 hr for analgesics in general; 24 hr for oxicams and other single daily or less frequently administered drugs) before patient evaluation visit.
- •Note: Aspirin at anti-aggregant doses (up to 325 mg per day) is not considered as an analgesic.
- •6 Patients who have received any treatment with intra-articular injections (e.g., corticosteroids) required for a flare-up within 4 weeks prior to randomisation.
- •7 Patients with functional class IV as defined by the ACR Classification of Functional Status in RA.
- •8 Patients with other inflammatory diseases that might confound the evaluation of the efficacy (e.g., Crohn’s disease, ulcerative colitis).
- •Note: Sjogren syndrome secondary to RA is allowed.
- •9 Patients who have received any investigational drug within 30 days or 5 times half-life, whichever is longer, prior to the first dose of study drug (or longer as per the local regulation of the country). Patients participating/ participated in another clinical trial evaluating a bDMARD for RA within the last year before Screening are not eligible for this trial.
- •10 Patients with a known history of or presence of clinically significant cardiovascular (any patient with New York Heart Association (NYHA) III/ IV functional status is to be excluded), haematological, renal, or liver disease. Patients with any other disorder or treatment that, in the Investigator’s opinion, may interfere with the safety of the patient, the validity of the study evaluations, or the patient compliance to the study procedures such as neurological diseases, psychiatric diseases, respiratory diseases, gastrointestinal diseases, endocrinological diseases, metabolic diseases or any other diseases. Special focus should be given to lung conditions to ensure it is sufficiently close to normal to avoid excessive risks upon study participation.
- •11 Patients with any history or current presence of known demyelinating disease.
- •12 Patients with any history of or presence of an active neoplasia except for successfully treated (at least five years in advance) non-metastatic cutaneous squamous cell or basal cell carcinoma and ?
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