Phase 3 Rheumatoid Arthritis Trial, Completed NCT02675426 Sponsor: AbbVie Condition: Rheumatoid Arthritis
Back to Rheumatoid Arthritis

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 661 people with rheumatoid arthritis across four groups. In the first phase (weeks 1 to 12), participants received either a placebo (dummy treatment), upadacitinib 15 mg, or upadacitinib 30 mg daily. The trial was measuring things like joint tenderness and swelling, overall disease activity scores, physical disability, and quality of life — all assessed at the 12-week mark. After week 12, participants continued into a longer follow-up phase lasting up to around five years, with some switching doses along the way. The reported data shows that for the main measures at week 12, 35.7% of people in the placebo group met a standard threshold for meaningful improvement in joint counts and other symptoms (known as ACR20), compared with 63.8% in the 15 mg group and 66.2% in the 30 mg group. For a separate main measure — reaching a "low disease activity" score on a 0–10 scale — 17.2% of the placebo group met that target, compared with 48.4% and 47.9% in the 15 mg and 30 mg groups respectively. The reported data also shows that disease activity scores fell by an average of about 1.0 points in the placebo group, versus around 2.2 and 2.3 points in the two upadacitinib groups. For the physical disability questionnaire (scored 0–3, where lower is better), average scores dropped by 0.25 in the placebo group and by about 0.54–0.59 in the upadacitinib groups. A quality-of-life physical score (where higher is better) rose by an average of 3.03 points with placebo and around 7.6–8.0 points with upadacitinib. Finally, 10% of the placebo group reached the "remission" threshold on the disease activity scale, compared with roughly 28–31% in the upadacitinib groups. 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

NCT02675426
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 are a man or woman aged 18 or older.
  • You have been diagnosed with rheumatoid arthritis (RA) for at least 3 months.
  • You have been taking a standard RA medication (such as methotrexate, sulfasalazine, hydroxychloroquine, chloroquine, or leflunomide) for at least 3 months, and your dose has stayed the same for at least 4 weeks before starting the trial.
  • At your screening and baseline appointments, you have at least 6 swollen joints and at least 6 tender joints, meaning your RA is still significantly active.
  • You may be eligible if you have previously tried one (and only one) biological RA medication, but only if you had trouble tolerating it or took it for less than 3 months, and you have waited the required amount of time since stopping it (confirm with trial site).

Who may not be able to join:

  • You have previously taken a type of medication called a JAK inhibitor, such as tofacitinib, baricitinib, or filgotinib.
  • You have a history of another inflammatory joint condition besides rheumatoid arthritis (having secondary Sjögren's Syndrome alongside RA is acceptable).
  • Your doctor determines that a biological RA medication you previously tried did not work well enough for you.

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 8 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: AbbVie Inc., AbbVie

Australian sites

Coffs Clinical Trials /ID# 138747, Coffs Harbour, New South Wales
Optimus Clinical Research Pty. /ID# 138769, Kogarah, New South Wales
Emeritus Research /ID# 138773, Camberwell, Victoria
Barwon Rheumatology /ID# 138772, Geelong, Victoria

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
17 December 2015
Est. completion
21 April 2017

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium Bosnia and Herzegovina 🇧🇬 Bulgaria 🇨🇦 Canada 🇭🇷 Croatia 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇰🇿 Kazakhstan 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇿 New Zealand 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇴 Romania 🇷🇺 Russia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12; Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12

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: 8 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