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NCT01662063 · ClinicalTrials.gov registry record · Phase 3

A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)

A Phase 3 study, sponsored by Genentech.

Completed
Registry status
Phase 3
Development phase
218
Enrollment target

NCT01662063: Completed Phase 3 study, sponsored by Genentech.

NCT01662063 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01662063, a Phase 3 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 3
Development phase
218 participants
Enrollment target

Study Summary

This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.

Primary Outcome

Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforeme

Interventions

  • DRUG Tocilizumab

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2012-08
Est. Completion 2014-06
Phase Phase 3
Genentech

332 total trials

What the finished NCT01662063 record still lists

NCT01662063 is an interventional study that assigns participants to a tested intervention. The registered 218 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 (72% lower).

The record links to 0 conditions, and to 1 intervention - of which Tocilizumab is the first listed.

NCT01662063 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01662063 about?

NCT01662063 is a clinical study titled "A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)". This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 mil...

What is the current status of trial NCT01662063?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2012-08. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01662063?

The interventions under investigation include: Tocilizumab (DRUG).

Who is sponsoring clinical trial NCT01662063?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01662063's enrollment target sits among peer trials

218 1331st of 2000 higher than 669 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 NCT01662063, the US trial registry maintained by the National Library of Medicine. NCT01662063 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.