NCT01187563: Tocilizumab with methotrexate in rheumatoid arthritis

Study: Regeneron's protocol 0000-RA-1008, observing tocilizumab with methotrexate in adults with moderately to severely active rheumatoid arthritis after an inadequate response to an anti-TNF drug. 1 2

Design and measurements: The reproduced registry description is single-arm, open-label, and observational: participants were already scheduled to receive tocilizumab as standard care. Clinical and laboratory assessments accompanied the first three monthly intravenous infusions, approximately ten weeks, to examine safety and pharmacodynamic mechanisms. The registry lists 16 actual enrollees, versus 15 expected in the narrative; that enrollment count does not establish an analyzed outcome population. 1 2

What is established: The historical record is completed, last updated in October 2011. No numerical disease-activity, biomarker, or adverse-event result was verified. This was not a pivotal randomized approval trial or a comparison establishing superiority over another rheumatoid-arthritis treatment. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT01187563. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT01187563. Original study registration: sponsor, design, population, endpoints and dated history.

2. Inspected CenterWatch reproduction of the registry description. Readable registry-data reproduction, not an independent efficacy study — Inspected CenterWatch reproduction of the registry description. Readable registry-data reproduction, not an independent efficacy study.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.