Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Hetero-Tocilizumab
Injection: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20
mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials for further dilution prior to intravenous infusion: 8mg/kg mg
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients of age 18 to 65 years (both inclusive) 2. 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 3. Patients with Swollen Joint Count (SJC) >=6 (66 joint count), and Tender Joint Count (TJC) >=6 (68 joint count) at screening and randomization 4. Patients with erythrocyte sedimentation rate of more than 28mm/hr measured by Westergren method and/or C-reactive protein >=10 mg/L 5. Patients who are on NSAIDs, must be on a stable dose for at least 8 weeks prior to randomization. 6. The screening laboratory tests must be: Haemoglobin >=9.0 g/dL, Absolute Neutrophil Count >=2.0 Ã? 109/L, Platelets >=100 Ã? 109/L, SGOT and SGPT <= ULN, Alkaline phosphatase levels <= ULN, Serum creatinine <=1.5 mg/dL
Exclusion criteria
Exclusion criteria: 1. Patients with known or suspected allergy or hypersensitivity to Tocilizumab or excipients 2. Patients with functional class IV disease as defined by the American College of Rheumatology (ACR) classification of functional status in RA 3. Patients with history of use of biological disease modifying anti-rheumatic drugs (bDMARDs) within 8 weeks prior to randomization. 4. Patients with history of intra-articular or parenteral corticosteroids use within 8 weeks prior to randomization. 5. Patients with active systemic bacterial, viral, fungal, mycobacterial, or other infections 6. Patients with history of treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to randomization 7. Patients with history or signs of lymphoproliferative disease 8. Patients who received live or live-attenuated vaccine within 8 weeks prior to randomization 9. Patients participated in an investigational drug study within 8 weeks prior to randomization. 10. Patients with history of blood donation or blood loss of >300ml within 3 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with ACR 20 response (â?¥20% improvement in the ACR core criteria)Timepoint: 8 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Disease Activity Score 28 (DAS28-ESR)Timepoint: 8 weeks, 12 weeks, and 24 weeks;Compare the single dose pharmacokinetic parameters of Cmax, AUC0-t, AUC0-â??Timepoint: Pre-dose, Post dose at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr, 336 hr, 504 hr and 672 hr after first dose;Compare the treatment emergent adverse events by monitoring of significant clinical signs and symptoms, and laboratory abnormalities during treatmentTimepoint: All Visits;Proportion of patients with ACR 20 response (â?¥20% improvement in the ACR core criteria)Timepoint: 24 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 | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Labs Limited
Outcome results
None listed