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 (NCT01194414) enrolled 1,262 people with rheumatoid arthritis — 631 in a group receiving tocilizumab by injection under the skin (subcutaneous, or SC) and 631 receiving it through a drip into a vein (intravenous, or IV). The first phase lasted 24 weeks and compared the two delivery methods in a blinded way (meaning participants did not know which form they were receiving). After that, most participants continued into a longer 72-week open-label phase (where the treatment type was known). The trial was measuring how participants' joint symptoms responded over time, as well as tracking any adverse events (unwanted health occurrences), serious adverse events, and notable changes in laboratory test results. The reported data shows that at 24 weeks, 69.4% of participants in the SC group and 73.4% in the IV group met what is called an "ACR20 response" — meaning their joint tenderness, swelling, and several other disease measures had each improved by at least 20% compared to the start of the trial. For a higher threshold of improvement (at least 50%, known as ACR50), the reported figures were 47.0% (SC) and 48.6% (IV); and for at least 70% improvement (ACR70), 24.0% (SC) and 27.9% (IV). Additionally, 38.4% of the SC group and 36.9% of the IV group reached a score considered to be in "remission" on a standard disease activity scale. Around 65.2% (SC) and 67.4% (IV) of participants showed a meaningful improvement in their self-reported ability to carry out daily activities. Regarding adverse events, the reported data shows that 91.6% of the SC group and 87.8% of the IV group experienced at least one adverse event (any unwanted health occurrence) during the study. Serious adverse events were reported in 13.9% (SC) and 12.7% (IV) of participants. Clinically significant changes in laboratory results were noted in 37.7% (SC) and 28.2% (IV). Similar figures were also reported for participants who switched between the two forms of the drug during the open-label phase, though the data as submitted does not clearly separate out which of these three categories each set of numbers belongs to for those switching groups. 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 26056119) ↗
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 are 18 years of age or older
- You have been diagnosed with rheumatoid arthritis (RA) for at least 6 months, based on recognised medical guidelines
- You have at least 4 swollen joints and at least 4 tender joints at the time of your first assessment and at the start of the trial
- Your current medications for RA (called DMARDs) have not been working well enough
- You have been taking your RA medications at the same dose for at least 8 weeks before the trial starts
- If you take steroid tablets (such as prednisone, up to 10mg per day) or anti-inflammatory painkillers, you have been on a stable dose for at least 4 weeks before the trial starts
Who may not be able to join:
- You have had a major operation (including joint surgery) in the 8 weeks before screening, or you are planning a major operation within 6 months of joining the trial
- You have another autoimmune or rheumatic disease in addition to RA
- Your RA is at the most severe functional level, meaning you are largely unable to carry out basic self-care activities (confirm with trial site)
- You were diagnosed with a form of childhood arthritis, or were diagnosed with RA before the age of 16
- You have had or currently have any other inflammatory joint condition besides RA
- You have had steroid injections into a joint or steroid injections/infusions in any other way within 4 weeks before the trial starts
- You have previously been treated with a medicine called tocilizumab
- You currently have an active infection, or you have a history of infections that keep coming back
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
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24; Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments
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.