CL04041024: Clinical Rheumatoid Arthritis Development for Olokizumab
Research type
Research Study
Full title
A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis.
IRAS ID
226146
Contact name
Hasan Tahir
Contact email
Sponsor organisation
R-Pharm CJSC
Eudract number
2015-005309-35
Clinicaltrials.gov Identifier
104933, IND Number
Duration of Study in the UK
1 years, 10 months, 3 days
Research summary
Research Summary
This is a multi-centre, open-label, Phase III study that will evaluate the efficacy and safety of Olokizumab in patients with moderately to severely active Rheumatoid Arthritis who previously completed 24 weeks of double-blind treatment in Study CL04041022, CL04041023, or CL04041025. The study will be conducted at approximately 250 global sites across Russia, Belarus, Georgia, Turkey, US, EU, Asia and Latin America. It is estimated that approximately 1880 patients will be enrolled.\nThe study will consist of an 82-week open-label Treatment Period, during which patients will be randomly assigned to 1 of 2 dosing frequencies of the study drug Olokizumab, either 64 mg once every 2 weeks, or 64 mg once every 4 weeks. The first visit of the Open-Label Extension (OLE) study is the same visit as the Week 24 visit in the core studies. \nAfter completion of the open-label Treatment Period and 2 weeks after the last dose of Olokizumab, patients will begin a 20-week Safety Follow-Up period. During the Safety Follow-Up period, patients will have to return to the hospital for 3 visits at Week 108, Week 112 and Week 126 to perform adequate safety assessments. The total amount of time to complete this open-label study will be approximately 102 weeks. \nPatients who discontinue treatment prematurely will be required to come for the End of Treatment (EoT) Visit 2 weeks after the last dose of study treatment was administered and then return 3 times after that for efficacy and safety assessments during the Safety Follow-Up Period. The visits during the Safety Follow-Up Period will be scheduled 4, 8 and 20 weeks after the EoT visit. In total 22 weeks after the final dose of study treatment.
Summary of Results
Lay summary of study results: This study with OKZ (study drug) 64 mg once every 4 weeks or OKZ 64 mg once every 2 weeks shows OKZ to be safe and well-tolerated over long-term treatment up to 104 weeks, with a safety profile consistent with previous OKZ studies. No new safety signals were detected with prolonged OKZ exposure. Efficacy of OKZ was maintained over the OLE period in subjects with moderately to severely active rheumatoid arthritis. Subjects who had previously received placebo responded quickly to OKZ, and that disease control resulting from prior adalimumab treatment was sustained after switching to OKZ treatment.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0957
Date of REC Opinion
20 Jun 2017
REC opinion
Favourable Opinion