Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Giant Cell Arteritis
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
Description
The study will be conducted at 3 sites (2 in New Zealand and 1 in Australia) The three pairwise product comparisons (DRL_TC vs. RP; DRL_TC vs RMP and RP vs. RMP) will be performed in parallel. Each comparison will be separately considered. Study subjects will be randomly assigned in a 1:1:1 ratio to...
The study will be conducted at 3 sites (2 in New Zealand and 1 in Australia) The three pairwise product comparisons (DRL_TC vs. RP; DRL_TC vs RMP and RP vs. RMP) will be performed in parallel. Each comparison will be separately considered. Study subjects will be randomly assigned in a 1:1:1 ratio to one of the comparisons and within each comparison subjects will be randomized in a 1:1 ratio to one of the two possible product sequences The total duration of the individual subject study participation will be approximately 12-16 weeks. Dosing for period 1 will be on on day 1 followed by washout out period of 6 weeks. Dosing for Period 2 will be on Day 43. Subjects who complete the study and are found to be positive for anti-drug antibodies (ADA) on Day 71 and/or Day 85, will be followed up every 90 days for immunogenicity sampling up to approximately one year post Period II dosing, or until two consecutive samples have been negative for ADA, whichever is earlier. Early dropouts will be tested for immunogenicity at the time of EOS and if they are positive for ADAs they will be followed-up if possible at 90 days intervals starting from the last received dose (either Period I or Period II) in a similar manner. 300 NHV (Normal Healthy Volunteers) will be included in the study as justified under sample size justification. After the data of these 300 volunteers become available a blinded sample size re-estimation (BSSR) will be performed to reconfirm the statistical assumptions of the study design and depending upon the outcome of the BSSR, study may be stopped or the sample size may be increased, as needed to attain the required statistical power.
Tracking Information
- NCT #
- NCT04885829
- Collaborators
- Dr. Reddy's Laboratories Limited
- Investigators
- Not Provided