EUCTR2019-004369-42-SK进行中（未招募）1 期
A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 542
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Are =18 years of age.
- •2. Diagnosis of rheumatoid arthritis according to the revised 1987
- •ACR/EULAR Classification 2010 criteria with disease duration of =6
- •3. Have moderately to severely active rheumatoid arthritis as defined by:
- •a.Swollen Joint Count =6 (66 joint count) and Tender Joint Count =6 (68
- •joint count)
- •4. Must have been treated with methotrexate for at least 12 consecutive
- •weeks immediately prior to randomization and are on a stable dose
- •between 10 and 25 mg/week methotrexate for the last 8 weeks prior to
- •5. Have had previous inadequate clinical response to at least one
- •XML File Identifier: yzY3ZiiM+wPVagTihKoX+xNzGD0=
- •modifying anti rheumatic drug.
- •6. Women of childbearing potential (i.e., considered fertile following
- •menarche and until becoming postmenopausal unless permanently
- •sterile) can participate only if they have a negative serum pregnancy
- •test at screening and a negative urine pregnancy test at Day -1 before
- •randomization. Women of childbearing potential must have used and
- •agree to use a highly effective contraception (i.e., methods with a failure
- •rate of less than 1% per year), for 4 weeks before randomization and
- •must agree to continue to practice adequate contraception for 3 months
- •after the last study drug administration.
- •Note: A separate ICF will be provided to and signed by each patient to
- •provide information on the general risks of study participation related to
- •COVID-19 and to document that it is understood by the patient. Another
- •separate Informed Consent Form will be required to be understood and
- •signed by partners of male participating patients who become pregnant
- •during the study or within 10 weeks after the participating patient's last
- •dose of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 298
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 244
排除标准
- •1. American College of Rheumatology functional class IV as defined by the ACR classification of functional status or heelchair/bedbound.
- •2. Rheumatic autoimmune disease or history of/current inflammatory joint disease other than rheumatoid arthritis or significant systemic involvement secondary to rheumatoid arthritis. Sjögren's syndrome secondary to rheumatoid arthritis is allowed.
- •3. Previously received tocilizumab, an investigational or licensed
- •biosimilar of tocilizumab or any interleukin-6 acting drugs (approved or investigational).
- •4. Prior use of targeted synthetic disease-modifying anti-rheumatic
- •drugs like janus kinase inhibitors
- •5. Prior use of any biological agent for a condition other than
- •rheumatoid arthritis (e.g., ranibizumab, denosumab).
- •6. Prior use of more than two biologic treatments for rheumatoid
- •7. Prior use of biologic investigational drugs (excluding biosimilars) for the treatment of rheumatoid arthritis.
- •8. Received any investigational drugs within 12 weeks or five drug half lives prior to screening or planned intake of an investigational drug during the course of this trial including the Follow-Up Period.
- •9. Previous treatment with any alkylating agents or cell-depleting
- •therapies including investigational drugs or approved biosimilars, or has previously undergone total lymphoid irradiation.
- •10. Use of non-steroidal anti-inflammatory drugs not at a stable dose
- •for at least 4 weeks prior to randomization or exceeding the maximum recommended dose. Note: Patients are permitted to take aspirin at a dose of =325 mg daily for cardiac prophylaxis.
- •11. Use of oral corticosteroids >10 mg/day prednisone or equivalent if the dose has not been stable for at least 6 weeks prior to randomization.
- •12. Intra-articular or parenteral corticosteroids within 4 weeks prior to randomization.
- •13. Use of high potency opioid analgesics
- •14. Has been treated with intravenous gamma globulin or
- •plasmapheresis within 6 months of randomization.
- •15. Received a live or attenuated vaccine within 4 weeks prior to
- •randomization.
- •16. History of hypersensitivity or severe allergic reactions to
- •monoclonal antibodies, any components of the study drug formulations, comparable drugs, or latex.
- •17. Patient is considered by the Investigator, for any reason, to be anunsuitable candidate for the study. Investigator should specifically
- •evaluate the patient's eligibility taking into consideration COVID-19 risk factors and situation.
- •18. Has a serious and/or unstable and/or poorly controlled medical
- •condition that, in the opinion of the Investigator, would put the patient at risk by participation in the study.
- •19. History of diverticulosis requiring antibiotic treatment or any other GI condition that might predispose the patient to gastrointestinal perforations.
- •20. Uncontrolled medical conditions for which flares are commonly
- •treated with corticosteroids or systemic corticosteroid treatment for
- •these conditions within the last 12 months prior to randomization.
- •21. Major surgery within 8 weeks prior to screening or planned major
- •surgery during the study.
- •22. History of, or current myeloproliferative or lymphoproliferative
- •disease or malignancy.
- •23. Medical evidence of current or history of primary or secondary
- •immunodeficiency as per Investigator's judgment.
- •24. Pre-existing or recent-onset central or peripheral nervous system
- •demyelinating disorder, or symptoms suggestive of such a disorder as
- •per Investigator's judgment.
- •25. Confirmed or, based
研究者
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