CTRI/2024/12/078285进行中（未招募）3 期
A randomised, double-blind, multicentre study to compare the immunogenicity and safety of proposed abatacept biosimilar (DRL_AB) with Reference abatacept (Orencia®) administered subcutaneously as an add-on to methotrexate in patients with moderately to severely active rheumatoid arthritis.
Dr. Reddys Laboratories Ltd.18 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1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
- 100
- 试验地点
- 18
- 主要终点
- Comparison of the incidence and prevalence of ADAs (towards whole abatacept and or CTLA 4) and NAb between Dr Reddys Abatacept and RMP in patients with active rheumatoid arthritis
研究概览
简要总结
The purpose of this study is to compare the immunogenicity and safety of proposed abatacept biosimilar (DRL_AB) with Orencia® administered by the SC route as an add-on to MTX in the treatment of patients with moderate to severe RA. The study duration will be up to 60 weeks including 4 weeks screening period. The drug administration will be up to Week 52 followed by EOS at Week 56 (4 weeks after the last dose).
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 Good Clinical Practice (GCP) guideline.
- •Male or female patients aged ≥ 18 years and ≤ 80 years at the time of signing informed consent.
- •Patients with moderately to severely active rheumatoid arthritis for at least 6 months’ duration, defined as per the American College of Rheumatology (ACR) Criteria, 1987 revision.
- •Active rheumatoid arthritis is defined as having: a.
- •Swollen Joint Count (SJC) ≥10 out of the 66 joints count b.
- •Tender Joint Count (TJC) ≥12 out of the 68 joints count, and c.
- •C-Reactive Protein (CRP) of at least 1.0 mg/dl determined using a highly sensitivity assay.
- •Patients must be on methotrexate (MTX) and folic acid for at least 3 months prior to the randomization with the below requirements.
- •Must have been treated with stable doses of MTX (between 20 to 25 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.
- •Patients who cannot tolerate higher dose of MTX should be on stable and tolerable dose of MTX for 4 weeks prior to randomisation (there should be documented evidence of intolerance to MTX).
- •Patients taking MTX must be on a stable dose of folic acid (≥5 mg per week) or equivalent for at least 4 weeks prior to randomisation.
- •Patients should not be on Conventional Disease-Modifying Anti-Rheumatic Drugs (cDMARDs) other than MTX for at least 4 weeks prior to randomization (4 weeks prior for azathioprine, sulfasalazine; 8 weeks for hydroxychloroquine & 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 randomization.
- •Patients 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 patients receiving Nonsteroidal 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 scheduled efficacy 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(as per the Clinical Trial Facilitation Group (CTFG) guidelines 2020) 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 patients should be permanently sterile by bilateral orchidectomy or agree to use appropriate contraception methods (Per the Clinical Trial Facilitation Group (CTFG) guidelines 2020) and not to donate or cryopreserve sperm during the study and for at least 6 months after the last dose of study drug.
- •Patients must be able to self-administer or must have help to administer the study treatment by caregiver.
排除标准
- •Patients who have received prior treatment with abatacept.
- •Patients who have received prior treatment with JAK inhibitors within the last 16 weeks of randomization (e.g., tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib etc.).
- •Patients who have received treatment with IV gamma globulin or plasmapheresis within 6 months of randomisation.
- •Patients with known contraindication to treatment with abatacept, including, but not restricted to hypersensitivity to abatacept or any excipients (dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, L-Histidine, sodium chloride, poloxamer and sucrose) in the study formulations.
- •Patients who need concomitant rheumatoid arthritis 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 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.
- •Patients who have received any treatment with intra-articular injections (e.g., corticosteroids) required for a flare-up within 4 weeks prior to randomisation.
- •Patients with functional class IV as defined by the ACR Classification of Functional Status in RA.
- •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 who have received any investigational drug within 30 days or 5 times half-life, whichever is longer, prior to randomization (or longer as per the local regulation of the country).
- •Patients participating or participated in another clinical trial evaluating a bDMARD for RA within the last year before screening are not eligible for this trial.
- •Patients with a known history of or presence of clinically significant cardiovascular (any patient with New York Heart Association (NYHA) III or 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.
- •Patients with any history or current presence of known demyelinating disease.
- •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 or localised carcinoma in situ of the cervix.
- •Patients with renal impairment (Cockcroft-Gault creatinine clearance less than 60 mL per min) or liver function impairment (bilirubin greater than 1.25 x Upper Limit of 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 Normalised 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.
- •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).
- •Patients with diseases that have immune suppression in their clinical course and or need for treatment with immune suppressive treatments such as patients with an organ graft requiring maintenance immune suppression.
- •Clinically significant chronic obstructive pulmonary disease (COPD) in the opinion of the Investigator.
- •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.
- •Patients with positive screening for hepatitis B surface antigen (HBsAg), hepatitis C or Human Immunodeficiency Virus (HIV).
- •Patients who received live virus vaccination within 3 months prior to randomisation or intention to receive live virus vaccination during the trial or up to 3 months after the last dose of the study drug.
- •Patients with acute or chronic unhealed clinically significant external wounds.
- •Female patients who are currently pregnant or breastfeeding.
- •Patients who are considered unreliable to follow study requirements and restrictions, in the opinion of the Investigator.
- •Patients who had major surgery including joint surgery within 8 weeks prior to randomisation or planned major surgery within 12 months following randomisation.
结局指标
主要结局
Comparison of the incidence and prevalence of ADAs (towards whole abatacept and or CTLA 4) and NAb between Dr Reddys Abatacept and RMP in patients with active rheumatoid arthritis
时间窗: Baseline through scheduled timepoints till Week 56 or EOS
Comparison of titers between Dr Reddys Abatacept and RMP dosed patients with active rheumatoid arthritis
时间窗: Baseline through scheduled timepoints till Week 56 or EOS
次要结局
- Efficacy:(Comparison of the following evaluations in both arms:)
研究者
研究点 (18)
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