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NCT01768572 · ClinicalTrials.gov registry record · Phase 3

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
202
Enrollment target

NCT01768572: Completed Phase 3 study, sponsored by Sanofi.

NCT01768572 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01768572, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
202 participants
Enrollment target

Study Summary

Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Primary Outcome

Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospital

Interventions

  • DRUG methotrexate
  • DRUG tocilizumab
  • DRUG hydroxychloroquine
  • DRUG sarilumab SAR153191 (REGN88)
  • DRUG sulfasalazine

Trial Details

FieldValue
Enrollment Target 202 participants
Start Date 2013-03
Est. Completion 2014-10
Phase Phase 3
Sanofi

713 total trials

What the finished NCT01768572 record still lists

NCT01768572 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 5 interventions - of which methotrexate is the first listed.

NCT01768572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01768572 about?

NCT01768572 is a clinical study titled "To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)". Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

What is the current status of trial NCT01768572?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2013-03. Estimated completion is 2014-10.

What interventions are being tested in trial NCT01768572?

The interventions under investigation include: methotrexate (DRUG), tocilizumab (DRUG), hydroxychloroquine (DRUG), sarilumab SAR153191 (REGN88) (DRUG), sulfasalazine (DRUG).

Who is sponsoring clinical trial NCT01768572?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01768572's enrollment target sits among peer trials

202 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01768572, the US trial registry maintained by the National Library of Medicine. NCT01768572 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.