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NCT01007435 · ClinicalTrials.gov registry record · Phase 3
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,162
- Enrollment target
NCT01007435 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,162 participants.
The verdict
NCT01007435, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,162 participants
- Enrollment target
Study Summary
This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.
Interventions
- DRUG Tocilizumab
- DRUG Methotrexate
- DRUG Placebo to tocilizumab
- DRUG Placebo to methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,162 participants |
| Start Date | 2009-10-31 |
| Est. Completion | 2014-01-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01007435
The ClinicalTrials.gov registry entry for NCT01007435 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,162 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 4 interventions - of which Tocilizumab is the first listed.
NCT01007435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01007435 about?
NCT01007435 is a clinical study titled "A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis". This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alo...
What is the current status of trial NCT01007435?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,162 participants. The study started on 2009-10-31. Estimated completion is 2014-01-28.
What interventions are being tested in trial NCT01007435?
The interventions under investigation include: Tocilizumab (DRUG), Methotrexate (DRUG), Placebo to tocilizumab (DRUG), Placebo to methotrexate (DRUG).
Who is sponsoring clinical trial NCT01007435?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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