A Randomized Double-Blind Parallel-Group Placebo-Controlled Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy

Brief description of study

This clinical research study will look at how safe and effective the study medication is in patients with rheumatoid arthritis (RA) over a longer period of time. It is a continuation study for people who have participated in one of three previous studies – CL04041022 (CREDO 1), CL04041023 (CREDO 2), or CL04041025 (CREDO 3) – involving the study medication. The study medication is called olokizumab and is an antibody that has been designed for use as a medication to treat RA. It is a manufactured antibody that blocks a substance called interleukin 6 (IL-6). IL-6 is a protein made by the white blood cells in your body and may be involved in the inflammation seen in RA. By blocking IL-6, the study medication stops it from working, thereby helping to reduce the symptoms of RA. The study medication is an investigational medication which means it is currently not approved by the U.S. Food and Drug Administration (FDA) and is not currently commercially available for the treatment of RA.

Clinical Study Identifier: s18-00245
ClinicalTrials.gov Identifier: NCT03120949
Principal Investigator: David H. Goddard.
Other Investigator: Margaret R. Li.

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