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 (NCT03843125) looked at a medicine called baricitinib in people with systemic lupus erythematosus (lupus), an autoimmune condition. A total of 1,147 participants took part, split across four groups: 388 received a 2 mg daily dose of baricitinib, 379 received a 4 mg daily dose, 189 received a placebo (dummy pill) matched to the 2 mg group, and 191 received a placebo matched to the 4 mg group. The trial's main focus was on tracking and recording side effects and any problems that arose during treatment, rather than measuring how well the medicine worked against lupus symptoms — though one secondary measure did look at disease response. The reported data shows that when it came to side effects that emerged or got worse during the study period, 61.9% of the 2 mg baricitinib group, 68.8% of the 4 mg baricitinib group, 65.1% of the placebo-to-2 mg group, and 64.4% of the placebo-to-4 mg group experienced at least one such event. For serious adverse events — meaning side effects serious enough to cause hospitalisation, be life-threatening, or have other major consequences — the reported figures were 11.1%, 13.5%, 11.1%, and 11.5% across the four groups respectively. A subset of specifically monitored events (such as infections, blood clots, and heart-related events) was reported in roughly 38–42% of baricitinib participants and 35–37% of placebo participants. Regarding temporary interruptions to the study medication, between about 19% and 25% of participants across all groups had their treatment paused at some point, while permanent stopping of the study drug was reported in roughly 4–6% across all groups. For the one secondary outcome — a combined lupus disease-response score — the reported data shows a result of zero for all four groups, meaning this particular measurement was not completed or data was not available for any participant in the way the trial defined it. 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 ↗

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.