Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Fresenius Kabi SwissBioSim GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are =18 years of age. 2. Have a body weight of 40 mIU/mL), or women who have undergone documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy are exempt from pregnancy testing. If necessary to confirm postmenopausal status, a follicle-stimulating hormone sample will be tested at screening. Females on hormone replacement therapy and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their hormone replacement therapy during the study. Otherwise, they must discontinue hormone replacement therapy to allow confirmation of postmenopausal status before study enrollment. Women who were taking hormone replacement therapy prior to study entry are allowed to participate in t
Exclusion criteria
Exclusion criteria: 1. American College of Rheumatology functional class IV as defined by the ACR classification of functional status or wheelchair/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. 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. 6. Prior use of more than two biologic treatments for rheumatoid arthritis. 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 (whichever is longer) 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. Use of paracetamol is allowed in the study. 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 an unsuitable 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 such as but not limited to poorly controlled diabetes, unstable ischemic heart disease, uncontrolled hypertension (systolic =160 mmHg and/or diastolic =95 mmHg) or other cardiovascular, cerebrovascular, gastrointestinal, hepatic, renal, hematological (including pancytopenia, aplastic anemia, or blood dyscrasia), endocrine, nervous system or pulmonary disease or other relevant medical condition or a history of clinically significant disease or any other 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 gastrointestinal 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate equivalent efficacy of proposed biosimilar tocilizumab MSB11456 and EU-approved RoActemra both administered subcutaneously to patients with moderately to severely active rheumatoid arthritis.;Secondary Objective: To compare the safety, immunogenicity and long-term efficacy of MSB11456 to EU-approved RoActemra.;Primary end point(s): The primary efficacy endpoint is the mean absolute change from baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24.;Timepoint(s) of evaluation of this end point: From baseline to Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - DAS28-ESR mean absolute change from baseline at all assessment visits (except Week 1) (i.e., at Weeks 2, 4, 8, 12, 16, 30, 42 and 52) other than Week 24. - ACR20 (20% improvement in ACR Core Set Measurements) response rate at Week 24. Safety: - Occurrence of treatment-emergent adverse events up to Week 24, Week 30, Week 55 and Week 63. - Occurrence of serious adverse events up to Week 24, Week 30, Week 55 and Week 63. Immunogenicity: - Antidrug antibody incidence at Weeks 2, 12, 24, 30, 52 and 55. - Antidrug antibody titer at Weeks 2, 12, 24, 30, 52 and 55. - Neutralizing antibody incidence at Weeks 2, 12, 24, 30, 52 and 55.;Timepoint(s) of evaluation of this end point: DAS28-ESR mean absolute change from baseline at all assessment visits excl. Week 1 and 24. ACR20 response rate at Week 24. Occurrence of treatment-emergent AEs up to Week 24, Week 30, Week 55 and Week 63. Occurrence of SAEs up to Week 24, Week 30, Week 55 and Week 63. Antidrug antibody incidence at Weeks 2, 12, 24, 30, 52 and 55. Antidrug antibody titer at Weeks 2, 12, 24, 30, 52 and 55. Neutralizing antibody incidence at Weeks 2, 12, 24, 30, 52 and 55. | — |
Countries
Bulgaria, Czech Republic, Georgia, Hungary, Moldova, Republic of, Poland, Russian Federation, Serbia, Slovakia, Spain, United States
Contacts
Public ContactClinical Development
Fresenius Kabi SwissBioSim GmbH
Outcome results
None listed