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NCT01855789 · ClinicalTrials.gov registry record · Phase 3
A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 718
- Enrollment target
NCT01855789: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01855789 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 718 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01855789, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 718 participants
- Enrollment target
Study Summary
This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (\</=) 3.2 at Week 24, will be randomized to either continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52. Participants without a DAS28 score \</=3.2 at Week 24, will continue the same treatment in a non-randomized open-label manner up to Week 52.
Primary Outcome
The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28 score could range from 0 to 10, wher
Interventions
- DRUG Methotrexate (MTX)
- DRUG Tocilizumab (TCZ)
- DRUG Placebo (PBO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 718 participants |
| Start Date | 2013-11-07 |
| Est. Completion | 2016-10-14 |
| Phase | Phase 3 |
What the finished NCT01855789 record still lists
NCT01855789 is an interventional study that assigns participants to a tested intervention. The registered 718 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Methotrexate (MTX) is the first listed.
NCT01855789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01855789 about?
NCT01855789 is a clinical study titled "A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX". This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment ...
What is the current status of trial NCT01855789?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 718 participants. The study started on 2013-11-07. Estimated completion is 2016-10-14.
What interventions are being tested in trial NCT01855789?
The interventions under investigation include: Methotrexate (MTX) (DRUG), Tocilizumab (TCZ) (DRUG), Placebo (PBO) (DRUG).
Who is sponsoring clinical trial NCT01855789?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01855789's enrollment target sits among peer trials
718 498th of 2000 higher than 1,503 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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