Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: BP08 Tocilizumab Injection 400mg/20ml in single dose vials for dilution prior to intravenous infusion: Dose of 8mg/kg body weight will be administered every 4 weeks for 24 weeks with th
Sponsors
CuraTeQ Biologics Private Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Adult male or female patients of age 18 to 65 years (both inclusive) Patients who are able to comply with study and follow-up procedures and provide written informed consent Patients with diagnosis of Active Rheumatoid Arthritis as per the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA score of â?¥6 and has a disease duration of at least three months before randomization Patients with Swollen Joint Count (SJC) â?¥6 (66 joint count), and Tender Joint Count (TJC) â?¥6 (68 joint count) at screening and randomization Patients who are on NSAIDs, must be on a stable dose for at least 4 weeks prior to randomization. Patient willing to receive oral folic acid (at least 5 mg/week or as per local practice) or folic acid (at least 1 mg/day or as per local practice) or equivalent during the trial period. Men and women of childbearing potential must agree to use adequate birth control measures and continue such precautions for 6 months after receiving the last injection
Exclusion criteria
Exclusion criteria: Patients with known or suspected allergy or hypersensitivity to Tocilizumab or formulation excipients Patients with functional class IV disease as defined by the American College of Rheumatology (ACR) classification of functional status in RA Patients with prior or current use of Tocilizumab Patients with autoimmune disease other than Rheumatoid Arthritis like psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohnâ??s disease (CD), ulcerative colitis(UC) and plaque psoriasis. Patients with active systemic bacterial, viral, fungal, mycobacterial, or other infections or on systemic antibiotics Patients with known history of active tuberculosis and tests positive in QuantiFERON®-TB Gold In-Tube (QFT-G) and Mantoux test at screening Patients with previous history of intestinal ulceration or diverticulitis. Patient with history of and/or current medical condition, classed as clinically significant by the investigator, including cardiac, gastrointestinal, renal, hepatic, hematological (including pancytopenia, aplastic anemia or blood dyscrasia), metabolic (including known diabetes mellitus), neurologic or pulmonary diseases, or psychiatric condition. Patients with history of any form of cancer within the 10 years except skin cancer and cervical cancer in-situ Patients with uncontrolled diabetes or hypertension Patients with history of New York Heart Association class III/IV congestive heart failure, unstable angina, cardiac arrythmias, or myocardial infarction within 6 months prior to randomization Patients with history or signs of lymphoproliferative disease Patients with significant systemic manifestations of rheumatoid arthritis such as vasculitis, interstitial lung disease, Pleuritis, pericarditis, Scleritis, Sjogren syndrome, Feltys syndrome and Lymphoma Patients must not be on prescription herbal, homeopathic or ayurvedic medicines including massage/manipulation therapies for at least one month prior to randomization. Patients with history of major surgery (including joint surgery) within 12 weeks prior to randomization Patients with history of alcohol or drug abuse within 6 months prior to randomization Patients with pregnancy or lactation at the time of screening Patients with HIV infection, chronic hepatitis B, or hepatitis C infection Patients with SARS CoV2 RT-PCR test positive at the time of screening Patients with history of blood donation or blood loss of >300ml within 3 months prior to randomization Patients with any medical, psychological, or social condition that may interfere with the patients participation in the study or evaluation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with ACR 20 response (â?¥20% improvement in the ACR core criteria)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with ACR 20 response (â?¥20% improvement in the ACR core criteria)Timepoint: 8 weeks and 12 weeks;Proportion of patients with an ACR 50 and ACR 70 response (â?¥50%, â?¥70% improvement in the ACR core criteria)Timepoint: 8 weeks, 12 weeks and 24 weeks;Change from baseline in Disease Activity Score 28 (DAS28-ESR) Timepoint: 8 weeks, 12 weeks, and 24 weeks;Change from baseline in Disease Activity Score 28 (DAS28-CRP)Timepoint: 8 weeks, 12 weeks, and 24 weeks;Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)Timepoint: 8 weeks, 12 weeks, and 24 weeks;Compare pharmacokinetic parametersTimepoint: As per pre-specified timepoints in the protocol;Treatment Emergent Adverse Events (TEAEs) evaluated on the basis of changes in clinical signs and symptoms and changes in safety laboratory valuesTimepoint: Baseline to week 28;Incidence and Titres of Anti-Tocilizumab Antibodies between both groupsTimepoint: As per pre-specified timepoints in the protocol | — |
Countries
India
Contacts
Public ContactMr Amardeep Singh
CuraTeQ Biologics Private Ltd.
Outcome results
None listed