Phase 4 Psoriatic Arthritis Trial, Completed NCT02814175 Sponsor: AbbVie Condition: Psoriatic 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 (NCT02814175) looked at psoriatic arthritis — a condition affecting the joints and skin. It ran in two parts. In Part 1, 122 people were assigned to receive an escalating dose of methotrexate (a medicine commonly used for arthritis) and 123 people received a combination of methotrexate plus adalimumab (a biological medicine given by injection). Part 2 involved a further 227 participants spread across four different groups, which examined various combinations and adjustments of these treatments. The trial was measuring things like joint activity, skin impact, pain, and overall quality of life. The reported data shows that for the main (primary) outcome in Part 1 — the proportion of people reaching a state called "minimal disease activity" (meaning at least 5 out of 7 markers of disease were at a low level) — 13.1% of those in the methotrexate-only group and 41.5% of those in the combination group reached that point. For the secondary outcomes, the reported data shows that skin-related quality of life scores (rated 0–30, where lower is better) fell by 3.1 points in the methotrexate group and 5.9 points in the combination group from where they started. A standard joint disease activity score (rated 0–10, lower is better) dropped by 0.9 and 2.0 points respectively, and a patient-reported impact score (also 0–10, lower is better) dropped by 1.7 and 3.3 points. A count of painful swollen fingers and toes (in those who had this at the start) fell by 0.9 and 2.8 respectively. Using another standard measure of joint improvement (ACR scores), the reported data shows that 32.8% versus 67.5% of participants achieved a 20% improvement level, 16.4% versus 45.5% achieved a 50% improvement level, and 8.2% versus 30.9% achieved a 70% improvement level. Outcome data for Part 2 groups was not reported in the submitted results. 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 4 Psoriatic Arthritis Trial, Completed

NCT02814175
Completed Phase 4 🇦🇺 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 Psoriatic Arthritis (a condition causing joint pain and skin symptoms) for at least 4 weeks before your screening appointment, confirmed using a standard set of medical criteria.
  • Your Psoriatic Arthritis is not currently well-controlled or in a low-disease state at the time of your screening.
  • You have 3 or more joints that are tender and 3 or more joints that are swollen.
  • You have been taking methotrexate (a common medication for arthritis) at a dose of 15 mg once a week for at least 4 weeks.

Who may not be able to join:

  • You have a medical reason why you cannot take adalimumab (a biologic medication), or you have had an allergic reaction to it or any of its ingredients.
  • You have previously had bad reactions or serious side effects from taking methotrexate.
  • You have a health condition that means your methotrexate dose cannot be increased above 15 mg per week (confirm with trial site).
  • You have previously taken any biologic medication, including TNF inhibitors (a type of medication that targets inflammation) or any other similar biologic treatments.

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: AbbVie Inc., AbbVie

Australian sites

Royal Prince Alfred Hospital /ID# 153144, Camperdown, New South Wales
Optimus Clinical Research Pty. /ID# 153145, Kogarah, New South Wales
Liverpool Hospital /ID# 153147, Liverpool, New South Wales
BJC Health /ID# 153875, Parramatta, New South Wales
Box Hill Hospital /ID# 153146, Melbourne, Victoria

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 4
Sponsor
Registry
ClinicalTrials.gov
Start date
5 August 2016
Est. completion
23 September 2019

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇴 Colombia 🇨🇿 Czechia 🇩🇪 Germany 🇮🇹 Italy 🇵🇱 Poland Puerto Rico Qatar 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 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: 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