New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Reliance Life Science’s Phase III clinical trial protocol of immunosuppressive Tocilizumab with some changes in exclusion criteria.
This came after the firm presented the proposal to conduct a Phase III clinical trial titled “A prospective, multicenter, randomized, double-blind, two-arm, parallel-group, active control, comparative clinical study to evaluate the efficacy and safety of R-TPR-055 (Tocilizumab) with RoActemra/Actemra in patients with active rheumatoid arthritis on a stable dose of methotrexate vide protocol no RLS/RA/2022/02 version 1.0 dated 28 Sep 2022.”
Tocilizumab is an interleukin-6 (IL-6) receptor antagonist. Interleukin 6 (IL-6) is a pro-inflammatory cytokine produced by cells including T-cells, B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 rapidly induces C-reactive protein, serum amyloid A, fibrinogen, haptoglobin, and α-1-antichymotrypsin while inhibiting the production of fibronectin, albumin, and transferrin.IL-6 also induces antibody production, induces cytotoxic T-cell differentiation, and inhibits regulatory T-cell differentiation. Tocilizumab binds soluble and membrane-bound IL-6 receptors, preventing IL-6-mediated inflammation.
Tocilizumab is indicated to treat moderate to severe rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Tocilizumab is also used to treat coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
At the recent SEC meeting for Analgesic and Rheumatology held on 15th March 2023, the expert panel reviewed the proposal to conduct the Phase III clinical trial titled “A prospective, multicenter, randomized, double-blind, two-arm, parallel-group, active control, comparative clinical study to evaluate the efficacy and safety of R-TPR-055 (Tocilizumab) with RoActemra/Actemra in patients with active rheumatoid arthritis on a stable dose of methotrexate vide protocol no RLS/RA/2022/02 version 1.0 dated 28 Sep 2022.
After detailed deliberation, the committee recommended the approval of the presented Phase III study protocol with the following changes in the exclusion criteria –
1. The patients with only major elective surgery should be excluded from the study.
2. Instead of a cross-over study, a direct comparison of the test arm and the reference arm should be done.
3. Non-responders figures in each arm should be included in the final analysis. Since the number of non-responders are not known prior, hence figures should be avoided in the study design.
Accordingly, the expert panel directed that the firm should submit the revised protocol to CDSCO.
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