Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,162 adults with rheumatoid arthritis across four treatment groups. Participants received either a placebo plus methotrexate, a lower dose of tocilizumab (4 mg/kg) plus methotrexate, a higher dose of tocilizumab (8 mg/kg) plus methotrexate, or the higher dose of tocilizumab plus a placebo instead of methotrexate. The trial measured disease activity using a scoring tool called DAS28 — a number calculated from joint counts, a blood marker of inflammation, and the patient's own rating of how they felt. A DAS28 score below 2.6 is considered "remission" (very low disease activity). The trial also tracked joint damage over time using X-ray scoring tools. The reported data shows that at 24 weeks, the percentage of participants whose DAS28 score fell into the remission range was 15.0% in the placebo-plus-methotrexate group, 31.9% in the lower-dose tocilizumab-plus-methotrexate group, 44.8% in the higher-dose tocilizumab-plus-methotrexate group, and 38.7% in the higher-dose tocilizumab-plus-placebo group. At 52 weeks, those figures were reported as 19.5%, 34.0%, 49.0%, and 39.4% respectively. The reported data also shows that changes in X-ray scores for joint damage at 52 weeks were small across all groups, with the placebo-plus-methotrexate group showing the largest average increase (1.14 points on a scale of 0–448), and the higher-dose tocilizumab-plus-methotrexate group showing the smallest average increase (0.08 points). Scores for a separate measure of joint improvement (the ACR score, which tracks swollen and tender joints alongside other symptoms) at both 24 and 52 weeks were also reported across the groups, but the data as submitted combines multiple time points and improvement thresholds together, so individual figures for each time point were not separately reported in a way that can be clearly distinguished. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 28389552) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Rheumatoid Arthritis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be 18 years of age or older.
- You must have been diagnosed with rheumatoid arthritis for 2 years or less.
- Your rheumatoid arthritis must be considered moderately to highly active, based on a standard disease activity measurement called the DAS28 score (confirm with trial site).
- You must have at least 4 swollen joints and at least 6 tender or painful joints.
- You must have tested positive for certain markers in your blood called rheumatoid factor (RF) and/or anti-CCP antibodies, OR if both are negative, you must have at least 1 area of joint damage (erosion) seen on imaging at your screening appointment.
- You must have signs of inflammation in your blood, shown by either a high ESR (28 mm/h or above) or a high CRP level (10 mg/L or above).
Who may not be able to join:
- You have previously been treated with a medication called tocilizumab.
- You have previously been treated with methotrexate or any biologic medication.
- You have a rheumatic or autoimmune condition other than rheumatoid arthritis.
- You have a history of, or currently have, any other inflammatory joint disease besides rheumatoid arthritis.
- Your rheumatoid arthritis severely limits your ability to carry out basic self-care activities, which doctors classify as "Functional Class IV" (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.