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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01007435 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,162 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A participant has a DAS28 remission response if their DAS28 \< 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a pa
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 |
What the finished NCT01007435 record still lists
NCT01007435 is an interventional study that assigns participants to a tested intervention. Its 1,162 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 4 interventions - of which Tocilizumab is the first listed.
NCT01007435 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01007435's enrollment target sits among peer trials
1,162 238th of 2000 higher than 1,763 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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