CTRI/2024/03/064580进行中（未招募）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.
Dr. Reddys Laboratories Ltd.21 个研究点 分布在 1 个国家目标入组 596 人开始时间: 2024年3月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 596
- 试验地点
- 21
- 主要终点
- Change in DAS28-CRP from Baseline to Week 13
研究概览
简要总结
This study is being conducted to evaluate efficacy equivalence between Dr. Reddy’s Abatacept and reference product. In addition, safety, immunogenicity will also be compared. This is in line with the guidelines issued by various regulatory agencies for development of biosimilars. The rationale for the main phase of study is to compare the efficacy, safety, and immunogenicity of DRL_AB in establishing biosimilarity; the transition phase is to rule out any difference between DRL_AB with RMP in safety or immunogenicity in RA patients who are already on treatment with the RMP when they switch to DRL_AB; and long term safety extension phase for evaluation of the safety following long term administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients should provide a written informed consent (as per the local regulations applicable to the study site and general good clinical practice (GCP) guidelines.
- •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.
- •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.
- •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.
- •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).
- •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.
- •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.
- •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.
- •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.
- •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.
- •OR 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.
- •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.
- •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.
- •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 andâ„or localised carcinoma in situ of the cervix.
- •13 Patients with renal impairment (Cockcroft-Gault creatinine clearance less than 60 mL/ min) or liver function impairment (bilirubin greater than 1.25 x Upper Limit Normal (ULN) (2.5xULN with indirect bilirubin contributing to greater than 80% of the total bilirubin as per the laboratory test for patients with documented Gilbert syndrome), international normalized ratio (INR) greater than 1.25, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 x ULN) at screening, unless the values are not clinically significant as per the investigator.
- •14 Patients with history of chronic alcoholism or drug abuse or other addictions (for the purposes of the study in the opinion of the Investigator; testing not necessary).
- •16 Clinically significant chronic obstructive pulmonary disease (COPD) in the opinion of the Investigator.
- •17 Patients with latent tuberculosis (TB) including patients with positive and indeterminate QuantiFERON-TB test at screening (QuantiFERON-Gold TB or other validated TB screening Interferon Gamma Release Assay).
- •Patients with history of active TB within 3 years of the start of study treatment can only be included if documentation of a completed treatment is provided.
- •Note: For indeterminate results, two repeats are allowed.
- •Patients may be re-screened and randomised after completing at least 3 months of prophylactic treatment with relevant appropriate medications as a standard approach, and treatment confirmed as effective in patient documentation before randomization.
- •In emergent situations, when the patient needs quick therapy for RA, 4 weeks of prophylactic treatment can be considered appropriate.
- •19 Patients with positive screening for hepatitis B surface antigen (HBsAg), hepatitis C or human immunodeficiency virus (HIV).
- •21 Patients with acute or chronic unhealed clinically significant external wounds.
- •22 Female patients who are currently pregnant or breastfeeding.
- •23 Patients who are considered unreliable to follow study requirements and restrictions, in the opinion of the Investigator.
- •24 Patients who had major surgery including joint surgery within 8 weeks prior to randomisation or planned major surgery within 6 months following randomisation.
- •Note: If any of the following Criteria are met, then it considered as major surgery: significant patient comorbidity, key surgical parameters (long operative duration, organ ischemia, blood loss greater than 1000 mL, high vasopressor use), postoperative metabolic stress response, 30-day morbidity greater than 30%, mortality greater than 2% and the need for intermediate or intensive care19.
结局指标
主要结局
Change in DAS28-CRP from Baseline to Week 13
时间窗: Time Frame: Baseline; Week 13
次要结局
- Change from Baseline in DAS28-ESR(Change from Baseline in DAS28-CRP)
- Incidence of AEs and SAEs(Incidence of AEs and SAEs during transition phase)
- Incidence of ADAs including NAb and ADA Titres(Incidence of ADAs including NAb and ADA Titres during transition phase Time Frame: Week 25; Week 33)
- Change in PD endpoints (ESR and CRP) from baseline to selected time points till Week 25(Baseline through scheduled time points till Week 25 and till Week 53/EOS)
- Population PK parameters(Baseline through scheduled time points till Week 53/EOS.)
研究者
研究点 (21)
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