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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 718 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01855789
The ClinicalTrials.gov registry entry for NCT01855789 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 718 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methotrexate (MTX) is the first listed.
NCT01855789 reports 0 study locations.
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.
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