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 involved 1,820 people in total across four groups. Participants had previously taken part in one of two related rheumatoid arthritis studies and were either receiving the drug sirukumab (at one of two doses — 50 mg every four weeks, or 100 mg every two weeks) or a placebo that was later switched to sirukumab. The trial was a long-term safety follow-up study, and its primary focus was on tracking a range of serious medical events — including serious adverse events broadly, major heart or stroke-related events, cancers, serious infections, bowel perforations, and liver or bile duct abnormalities. The reported data shows the following percentages of participants who experienced each type of event. For serious adverse events overall: 21.3% in the placebo-to-50 mg group, 27.8% in the placebo-to-100 mg group, 26.4% in the sirukumab 50 mg group, and 23.1% in the sirukumab 100 mg group. For major cardiovascular events (such as heart attack, stroke, or death): 2.0%, 0.7%, 2.3%, and 1.1% respectively. For cancers: 1.0%, 3.4%, 1.5%, and 1.8%. For serious infections: 7.9%, 12.0%, 10.4%, and 10.7%. For bowel perforations (a hole in the gut wall): 0.7%, 1.4%, 0.7%, and 0.5%. For liver or bile duct abnormalities: 0%, 0.3%, 0.2%, and 0.2%. It is worth noting that very few participants are recorded as having formally "completed" the study (fewer than 30 across all four groups combined), with the large majority recorded as not completing it — the reasons for this are not detailed in the reported data. The reported figures above reflect what was recorded across the time participants were in the study. 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 33526709) ↗
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 have already completed participation in one of two specific related studies (called CNTO136ARA3002 or CNTO136ARA3003).
- You must be willing to sign a consent form showing you understand what the study involves and agree to take part.
- You must be willing to sign a separate consent form for an optional genetics portion of the study, which looks at how your genes may affect how a drug works — note that choosing not to take part in this optional genetics part will not stop you from joining the main study.
Who may not be able to join:
- You withdrew your consent or stopped taking part in the related previous study (CNTO136ARA3002 or CNTO136ARA3003).
- You are currently pregnant.
- You currently have an active condition called diverticulitis, which is inflammation or infection in pouches that can form in the walls of the digestive system (confirm with trial site).
- You have any other health condition that the study doctor believes could put you at risk, affect your wellbeing, or interfere with the study's assessments.
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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Serious Adverse Events (SAEs); Percentage of Participants With Major Adverse Cardiovascular Events (MACE); Percentage of Participants With Malignancies; Percentage of Participants With Serious Infections; Percentage of Participants With Gastrointestinal (GI) Perforations; Percentage of Participants With Hepatobiliary Abnormalities; Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.