Phase 2 Rheumatoid Arthritis Trial, Completed NCT00837811 Sponsor: Eli Lilly and Company Condition: Rheumatoid Arthritis
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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 (NCT00837811) looked at a medicine called LY2127399 in people with rheumatoid arthritis. It was an extension study, meaning participants had already taken part in one of two earlier related trials. A total of 182 people were enrolled across three groups, which differed by the dose they received: 60 people received a steady 60 mg dose, 121 people received a dose that varied between 60 mg and 120 mg, and 1 person was in a third dosing group. The trial's primary focus was on tracking unwanted medical events (called adverse events) and serious adverse events that occurred while participants were taking the study drug, as well as any unusual results from blood and urine tests. The reported data shows that, among those who experienced any unwanted medical event during treatment, 38 out of 60 participants were recorded in the 60 mg group, and 95 out of 121 in the 60/120 mg group. Serious adverse events were reported in 4 participants in the 60 mg group and 16 in the 60/120 mg group. Abnormal laboratory results reported as adverse events were very rare — only 1 participant in the 60/120 mg group during treatment, and 1 in the same group during the follow-up period. The reported data also shows changes in several secondary measures across groups. For the number of tender joints (out of 28 checked), the average change from the starting point was −9.2 joints in the 60 mg group and −6.5 joints in the 60/120 mg group. For swollen joints, the reported average change was −7.6 in the 60 mg group and −5.3 in the 60/120 mg group. On a 0–100 scale where participants rated their own arthritis activity, the average reported change was −26.1 mm in the 60 mg group and −16.7 mm in the 60/120 mg group. Physicians' ratings on the same type of scale showed average changes of −29.1 mm and −18.4 mm respectively. Results for the third dosing group (one participant only) are included in the submitted data but are not meaningful to describe given the very small number involved. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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 2 Rheumatoid Arthritis Trial, Completed

NCT00837811
Completed Phase 2 🇦🇺 Australian site

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 have signed and given written consent to take part in the study.
  • Women must not be pregnant, breastfeeding, or likely to become pregnant during the study.
  • You must have previously taken part in one of two specific earlier studies (called NCT00689728 or NCT00785928).

Who may not be able to join:

  • During one of the two earlier studies, you experienced a serious safety concern — such as a serious infection, a severe reaction to the study drug, or any bad reaction that caused you to stop treatment — that the study doctor believes makes it too risky for you to continue.
  • During one of the two earlier studies, you received a medication that was not allowed by the study rules, including certain unapproved drugs, specific medications used to treat conditions like arthritis (confirm with trial site), or live vaccines.
  • You are currently enrolled in another clinical trial that involves an experimental drug or device, or you are taking part in any other type of medical research study.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST), Eli Lilly and Company

Australian sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Elizabeth Vale, South Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 February 2009
Est. completion
1 January 2011

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇲🇽 Mexico 🇵🇱 Poland Puerto Rico 🇷🇴 Romania 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov