A Study to evaluate the effect of BP08(Tocilizumab) for treatment of moderate to severe Rheumatoid Arthritis.
- Conditions
- Health Condition 1: M069- Rheumatoid arthritis, unspecified
- Registration Number
- CTRI/2023/01/049000
- Lead Sponsor
- CuraTeQ Biologics Private Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 =6 and has a disease duration of at least three months before randomization
Patients with Swollen Joint Count (SJC) =6 (66 joint count), and Tender Joint Count (TJC) =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
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), Crohn’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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with ACR 20 response (=20% improvement in the ACR core criteria)Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in Disease Activity Score 28 (DAS28-CRP)Timepoint: 8 weeks, 12 weeks, and 24 weeks;Change from baseline in Disease Activity Score 28 (DAS28-ESR) <br/ ><br>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;Incidence and Titres of Anti-Tocilizumab Antibodies between both groupsTimepoint: As per pre-specified timepoints in the protocol;Proportion of patients with ACR 20 response (=20% improvement in the ACR core criteria)Timepoint: 8 weeks and 12 weeks;Proportion of patients with an ACR 50 and ACR 70 response (=50%, =70% improvement in the ACR core criteria)Timepoint: 8 weeks, 12 weeks and 24 weeks;Treatment Emergent Adverse Events (TEAEs) evaluated on the basis of changes in <br/ ><br>clinical signs and symptoms and changes in safety laboratory valuesTimepoint: Baseline to week 28