Phase 3 Rheumatoid Arthritis Trial, Completed NCT02222493 Sponsor: Pfizer 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 324 participants in the PF-06438179 group (a biosimilar medicine) and 326 in the infliximab (brand name Remicade) group — a total of 650 people at the start. The trial ran across three periods covering roughly 78 weeks in total. Because participants were switched between treatments at certain points, the group numbers shifted across the three periods. The trial was measuring how many participants showed meaningful improvements in rheumatoid arthritis symptoms using a standard set of joint and wellbeing assessments, known as ACR response scores — essentially counting improvements in painful and swollen joints alongside other measures like pain ratings and physical function. The reported data shows that at the main measurement point (week 14), 198 out of 324 participants in the PF-06438179 group and 207 out of 326 in the infliximab group met the threshold for at least a 20% improvement across the required measures (called an ACR20 response). At earlier and later check-ins during the first 30 weeks, the numbers of participants meeting this same 20% improvement threshold ranged from around 105 to 210 in the PF-06438179 group and 121 to 214 in the infliximab group. The reported data also shows that when participants were switched from infliximab to PF-06438179 from week 30 onward, the numbers meeting the ACR20 threshold remained in a broadly similar range through to week 78, though the data was not reported in a way that allows straightforward before-and-after comparison for every individual. For the higher improvement thresholds (50% improvement, or ACR50), the reported numbers were lower across both groups, as would be expected. 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

NCT02222493
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 have been diagnosed with rheumatoid arthritis (a condition causing joint inflammation) for at least 4 months, based on specific medical guidelines
  • You have at least 6 painful and 6 swollen joints (out of a standard set checked by a doctor) at two separate check-in appointments
  • Your blood test shows a certain level of inflammation marker (called hs-CRP) at 10 mg/L or higher
  • You have been taking a medicine called methotrexate for at least 12 weeks, and your dose has stayed the same for at least the last 4 weeks

Who may not be able to join:

  • You have tuberculosis (TB) that has not been treated or has not been treated well enough
  • You have been diagnosed with moderate or severe heart failure (confirm with trial site)
  • You had a serious infection in the 6 months before the trial start that required a hospital stay or intravenous/injected antibiotics

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 19 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: Pfizer CT.gov Call Center, Pfizer

Australian sites

Gold Coast Private Hospital Pty Ltd, Southport, Queensland
HPS Pharmacies, Southport, Queensland
Paradise Arthritis and Rheumatology Pty Ltd, Southport, Queensland
The Queen Elizabeth Hospital, Woodville South, South Australia
CliniPath Pathology, Osborne Park, Western Australia
R.K. Will Pty Ltd, Victoria Park, Western Australia

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

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
26 August 2014
Est. completion
29 June 2016

Where this trial is recruiting

🇦🇺 Australia Bosnia and Herzegovina 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇬🇪 Georgia 🇩🇪 Germany Guatemala 🇭🇺 Hungary 🇮🇱 Israel 🇯🇵 Japan 🇯🇴 Jordan 🇱🇹 Lithuania 🇲🇽 Mexico Morocco 🇵🇪 Peru 🇵🇭 Philippines 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇿🇦 South Africa 🇰🇷 South Korea Tunisia 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1

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: 19 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