CTRI/2023/01/049000 [Registered on: 13/01/2023] Trial Registered Prospectively
Last Modified On:
10/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Study to evaluate the effect of BP08(Tocilizumab) for treatment of moderate to severe Rheumatoid Arthritis.
Scientific Title of Study
A Randomized, Double Blind, Multicenter, Parallel Group Study to Compare Efficacy, Safety, Immunogenicity, Pharmacokinetics and
Pharmacodynamics of BP08 (Tocilizumab) and RoActemra® in patients with moderate to severe Rheumatoid Arthritis (RA) with inadequate response to Methotrexate
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
ICS/CUR/2022-006 Version 2.0 dated 27 Sep 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Arpitkumar Prajapati
Designation
Deputy General Manager
Affiliation
CuraTeQ Biologics Private Ltd.
Address
CuraTeQ Biologics Private Ltd.
Galaxy, Floors 22-24,
Survey No. 83/1, Hyderabad
Knowledge City,
Hyderabad, Telangana, India
Hyderabad TELANGANA 500081 India
Phone
8455255222
Fax
Email
arpitkumar.Prajapati@curateqbio.com
Details of Contact Person Public Query
Name
Mr Amardeep Singh
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India
North West DELHI 110034 India
Phone
011-49049115
Fax
011-49049115
Email
clinical.operations@insigniacs.com
Source of Monetary or Material Support
CuraTeQ Biologics Private Ltd.
Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City, Hyderabad, Telangana, India, 500 081
Primary Sponsor
Name
CuraTeQ Biologics Private Ltd.
Address
Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City, Hyderabad, Telangana, India, 500081
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 the background therapy of Methotrexate
Comparator Agent
RoActmera® 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 the background therapy of Methotrexate
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria)
12 weeks
Secondary Outcome
Outcome
TimePoints
Proportion of patients with ACR 20 response (≥20% improvement in the ACR core criteria)
8 weeks and 12 weeks
Proportion of patients with an ACR 50 and ACR 70 response (≥50%, ≥70% improvement in the ACR core criteria)
8 weeks, 12 weeks and 24 weeks
Change from baseline in Disease Activity Score 28 (DAS28-ESR)
8 weeks, 12 weeks, and 24 weeks
Change from baseline in Disease Activity Score 28 (DAS28-CRP)
8 weeks, 12 weeks, and 24 weeks
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
8 weeks, 12 weeks, and 24 weeks
Compare pharmacokinetic parameters
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 values
Baseline to week 28
Incidence and Titres of Anti-Tocilizumab Antibodies between both groups
As per pre-specified timepoints in the protocol
Target Sample Size
Total Sample Size="204" Sample Size from India="204" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Rheumatoid arthritis is a chronic, serious progressive and debilitating inflammatory disease characterized by joint swelling, joint tenderness, and destruction of synovial joints, leading to severe disability and premature mortality. RA is considered as an auto immune disease. The etiology of RA is thought to be multifactorial and is not fully understood; however, pro-inflammatory cytokines (tumour necrosis factor [TNF]-α, interleukin [IL]-6, IL-1β) are known to play a role in the disease pathogenesis in RA by propagating inflammation and leading to joint destruction.
This is a Phase I/III, Multicentric, Comparative, Randomized, Double blind, Active Controlled, Parallel group clinical study to evaluate and compare the efficacy, pharmacokinetics, pharmacodynamics, immunogenicity and safety of intravenous injection of BP08 (Tocilizumab) mfg. by CuraTeQ Biologics Private Limited with reference medicinal product RoActmera® (Tocilizumab of Hoffman La Roche) injection in patients with rheumatoid arthritis.