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Psoriatic arthritis drug apremilast tracked for two years in Real-World study

NCT ID NCT03106051

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study followed 526 adults with active psoriatic arthritis who were already prescribed apremilast (Otezla) by their doctors. Researchers observed them for up to 100 weeks to see how well the drug controlled their symptoms in everyday practice. The goal was to gather long-term data on effectiveness and safety outside of a controlled trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apremilast (Otezla)
What this could lead to
If successful, this study could confirm that apremilast is a safe and effective long-term option for managing psoriatic arthritis symptoms in everyday practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It does not test a new treatment, only documents existing use, and long-term benefits or risks remain uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

526 people

The number who actually took part.

Started

Feb 2016

Finished

Aug 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Overall approx. 500 patients with active psoriatic arthritis are to be enrolled. Inclusion and exclusion criteria derive from the current Otezla® summary of product characteristics and the criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The decision to treat with Otezla® has been made independently before inclusion in this study * Patient age ≥ 18 years * Existing diagnosis of active psoriatic arthritis * At least moderately severe psoriatic arthritis (Physician's Global Assessment (PGA) scale ≥ 2) * Insufficient response or intolerance to previous Disease-Modifying Anti-Rheumatic Drug (DMARD) treatment (disease modifying anti-rheumatic drugs) * A written informed consent statement by the patient permitting data collection, evaluation, storage and transfer Exclusion Criteria: * Pregnancy * Hypersensitivity to apremilast or one of the other ingredients in the film tablets * Other criteria according to the summary of product characteristics Breast-feeding

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Conditions

The condition(s) this trial relates to.

arthritic joint disease psoriatic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis, psoriatic

Contacts and locations

Locations

  • Klinikum Stephansplatz

    Hamburg, 20354, Germany

  • Rheumatology at Struenseehaus

    Altona, Free and Hanseatic City of Hamburg, 22767, Germany

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