At a glance
ClinicalIndex Comparison Record- ✓Completed 24-week double-blind treatment period in one of three core studies (CL04041022, CL04041023, or CL04041025)
- ✓Maintained stable methotrexate dose of 15–25 mg/week (or ≥10 mg/week if documented intolerance to higher doses) and plans to continue for ≥12 weeks
- ✓Willing to take folic acid or equivalent throughout the study
- ✕Any medically important condition (clinically significant lab values, frequent or serious adverse events, infection-related SAEs, uncontrolled medical condition) making subject unsuitable per investigator judgment
- ✕Active tuberculosis
- ✕Positive or repeated indeterminate IGRA at Week 22 of core study unless active TB ruled out by TB specialist/pulmonologist and latent TB prophylaxis started per CDC/country guidelines (excluding isoniazid monotherapy for 6 months), with patient commitment to complete prophylaxis
- ✕Planned surgery during first 12 weeks of open-label extension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 2,106 participants across 239 sites in 18 countries.
Detailed Summary
The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.
Study Details
Timeline
Interventions
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.) Folic acid ≥ 5 mg per week or equivalent