Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Olokizumab (OKZ): A dose of 64 mg [0.4 mL dose from the 2 mL vial containing 160 mg/ mL] of OKZ will be administered as an injection by the SC route at 4 weeks intervals for a total pe
the last dose given at Week 21).
Control Intervention1: Not applicable: Not applicable
Sponsors
Dr. Reddy s Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient between 18 to 80 years (both inclusive) of age at the time of signing the informed consent. 2. Patient willing and able to voluntarily provide informed consent for participation as per the applicable local regulations. 3. Diagnosis of adult onset RA, classified as per ACR or EULAR 2010 revised classification criteria for RA, for at least 24 weeks prior to start of study treatment. a. If the patient was diagnosed previously according to ACR 1987 criteria, the Investigator can reclassify the patient per ACR or EULAR 2010, using retrospectively available source data. 4. Patient has moderately to severely active RA disease as defined by all of the following: a. greater than or equal to 6 tender joints (68-joint count) at Screening and prior to start of study treatment; and b. greater than or equal to 6 swollen joints (66-joint count) at Screening and prior to start of study treatment; and c. C reactive protein above upper limit of normal (ULN) at Screening and prior to start of study treatment. 5. Inadequate response to treatment with oral, SC, or intramuscular (IM) MTX for at least 12 weeks prior to start of study treatment at a dose of 15 to 25 mg per week (or greater than or equal to 7.5 mg per week in case of documented intolerance to higher doses) 6. Stable dose and route of administration of MTX for at least 8 weeks before start of study treatment with patient on folic acid or equivalent (greater than or equal to 5 mg per week) for at least the same period (8 weeks). 7. Patient must be able to comply with all study requirements in the opinion of the Investigator.
Exclusion criteria
Exclusion criteria: 1. Patients with diagnosis of any other inflammatory arthritis or systemic rheumatic disease (Example gout, psoriatic or reactive arthritis, Crohns disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus). Note: Patients with secondary Sjogrens syndrome or hypothyroidism (even if, of autoimmune aetiology) clinically well controlled as assessed by the Investigator, are allowed in the study. 2. Patients with Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed ridden, or confined to a wheelchair, with little or no selfcare) 3. Patients having prior exposure to any licensed or investigational compound directly or indirectly targeting IL6 or IL6R (including tofacitinib or other Janus kinase and spleen tyrosine kinase inhibitors). 4. Patients who received prior treatment with cell-depleting therapies, including antiCD20 or investigational agents (e.g., CAMPATH [alemtuzumab], antiCD3, antiCD4, antiCD5, and antiCD19 agents). 5. Patients with prior use history or ongoing use of bDMARDs (except TNFi after adequate washout period in case of inadequate response). 6. Patients using parenteral and or intra-articular glucocorticoids within 4 weeks prior to start of study treatment should be excluded. Use of oral glucocorticoids at doses greater than 10 mg per day prednisone (or equivalent) or change in glucocorticoid dosage within 2 weeks prior to start of study treatment should be excluded. 7. Patients with prior use of cDMARDs (other than MTX) or TNFi within the following window period prior to start of study treatment [Note cDMARDs or TNFi should not be discontinued to facilitate a patients participation in the study but instead should have been previously discontinued as part of the patient s medical management of RA]. a. 4 weeks for etanercept, sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline b. 8 weeks for infliximab c. 12 weeks for leflunomide, adalimumab, certolizumab, golimumab and other TNFi d. 24 weeks for cyclophosphamide 8. Patients who received vaccination with live vaccines in the 6 weeks prior to start of study treatment or have planned vaccination with live vaccines during the study. 9. Patients who participated in any other investigational drug study within 30 days or 5 times the terminal half life of the investigational drug (24 weeks if half life of the investigational drug is unknown), whichever was longer, prior to start of study treatment. 10. Patients who have received any other treatments for RA (which may include Prosorba column, etc.) within 6 months prior to start of study treatment. 11. Patients with use of intraarticular hyaluronic acid injections within 4 weeks prior to start of study treatment. 12. Patients with use of non-steroidal antiinflammatory drugs on unstable dose or switching of NSAIDs within 2 weeks prior to start of study treatment. 13. Patients having any of the following abnormal laboratory values at Screening a. eGFR 60 ml per min per m2 or less determined by the CKDEPI 2021 equation with creatinine only and without race factors. b. Serum alanine aminotransferase or aspartate aminotransferase level greater than or equal to 1.5 X ULN c. Platelet count less than 100 X 109 per L (less than 100, 000 mm3) d. White blood cell
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To assess the efficacy of OKZ in patients with moderate to severe active RA, inadequately controlled by ongoing MTX therapy.Timepoint: Primary Endpoint: The following parameter will be assessed in patients with moderately to severely active RA treated with OKZ: ACR20 response after 12 weeks of treatment [Time Frame: Baseline (Week 1); Week 13 (Assessment should be performed prior to Week 1 and Week 13 dose administration)] A responder is defined as any patient satisfying ACR20 criteria in the study up to Week 12 completion (Week 13 Visit day Prior to study drug administration). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: To assess the efficacy by different assessment criteria of OKZ during and up to 24 weeks of treatment To assess the safety and tolerability of OKZ To assess the physical function and quality of life in patients receiving OKZ To assess the immunogenicity of OKZTimepoint: Secondary End points: Secondary Efficacy endpoints: The following parameters will be assessed in patients with moderate to severe active RA treated with OKZ Percentage of patients achieving low disease activity, as per EULAR response, defined as DAS28 CRP less than 3.2 in the study till Week 13 and 25 [Time Frame: Baseline (Week 1); Week 13; EOT (Week 25)] Improvement of physical ability from Baseline over time, as measured by the Health Assessment Questionnaire Disability Index (HAQ DI) [Time Frame: Baseline (Week 1), Week 5; Week 9; Week 13; Week 17; Week 21; EOT (Week 25)] Proportion of patients achieving an ACR20, ACR50, and ACR70 response in the study [Time Frame: Baseline (Week 1); Week 5; Week 9; Week 13 (except ACR 20, which is primary endpoint); Week 17; Week 21; EOT (Week 25)] Change from Baseline over time in DAS28 CRP and Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) [Time Frame: Baseline (Week 1), Week 5; Week 9; Week 13; Week 17; Week 21; EOT (Week 25)] Secondary Safety endpoints: The following parameters will be assessed in patients with moderate to severe active RA treated with OKZ Proportion of patients with AEs, and SAEs [Time Frame: Baseline (Week 1) to EOT (Week 25); EOS (Week 33) Nature, incidence, severity, and outcome of AEs of special interest (AESIs) [Time Frame: Baseline (Week 1) to EOT (Week 25); EOS (Week 33)] Incidence of anti-drug antibodies (ADA) including Neutralising Antibodies (NAb) [Time Frame: Baseline (Week 1) through scheduled time points till EOT (Week 25)] ADA Titres [Time Frame: Baseline (Week 1) through scheduled time points till EOT (Week 25)] Time course of antibodies, defined as the time | — |
Countries
India
Contacts
Public ContactK Ranjith
Dr. Reddys Laboratories Ltd.
Outcome results
None listed