Phase 3 Rheumatoid Arthritis Trial, Completed NCT01519791 Sponsor: UCB Pharma SA 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 enrolled 879 people in total — 219 in the placebo plus methotrexate group and 660 in the certolizumab pegol plus methotrexate group. The trial was measuring whether adding certolizumab pegol to methotrexate (a common medicine for inflammatory joint conditions) made a difference compared to adding a placebo (an inactive dummy treatment) to methotrexate. The main thing the trial was looking at was how many participants reached a sustained state of low disease activity — specifically, scoring below a certain threshold on a joint disease activity scale at both Week 40 and Week 52 of the study. The reported data shows that for the primary goal — the percentage of people who reached sustained remission (that is, a low disease activity score at both Weeks 40 and 52) — 15.0% of people in the placebo plus methotrexate group met this measure, compared with 28.9% in the certolizumab pegol plus methotrexate group. For a related secondary measure looking at a slightly broader category called "sustained low disease activity," the reported figures were 28.6% for the placebo group and 43.8% for the certolizumab pegol group. The trial also looked at joint damage using X-ray scoring. The reported data shows the average change in overall joint damage score from the start to Week 52 was 1.8 points in the placebo group and 0.2 points in the certolizumab pegol group (on a scale where higher numbers mean more damage). Additionally, 49.7% of the placebo group showed no meaningful progression of joint damage on X-ray, compared with 70.3% in the certolizumab pegol group. 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 3 Rheumatoid Arthritis Trial, Completed

NCT01519791
Completed Phase 3 🇦🇺 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 were diagnosed with Rheumatoid Arthritis (RA) as an adult, and your diagnosis was made less than 1 year ago
  • Your blood tests show positive results for certain markers linked to RA (called Rheumatoid Factor and/or anti-CCP antibodies)
  • Your RA is currently active (meaning you are experiencing symptoms)
  • You have never taken any disease-modifying drugs (DMARDs) to treat RA
  • You have never received any biologic treatments for RA

Who may not be able to join:

  • You have been diagnosed with any other type of inflammatory joint condition
  • You have a history of a joint replacement that became infected, or you have had other serious infections or significant medical conditions
  • You have been diagnosed with Tuberculosis (TB), or you are considered at high risk of getting a TB infection

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 20 July 2026
Phase 3: approximately ~65% 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: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

Australian sites

6, Coffs Harbour, New South Wales
2, Herson, Queensland
1, Maroochydore, Queensland
8, Woodville South, South Australia
5, Fitzroy, Victoria
4, Geelong, Victoria
3, Malvern, Victoria
7, Perth, Western 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 3
Sponsor
UCB Pharma SA
Registry
ClinicalTrials.gov
Start date
1 January 2012
Est. completion
1 July 2014

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇨🇴 Colombia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇲🇽 Mexico Monaco 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Subjects in Sustained Remission at Week 52

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: 20 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