Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Study tests if starting stronger drugs earlier tames psoriatic arthritis

NCT ID NCT03739853

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested whether starting stronger medications early helps people with moderate to severe psoriatic arthritis more than the usual step-up approach. 192 adults were randomly assigned to standard care, early combination disease-modifying drugs, or early TNF inhibitors. The study measured disease activity using a composite score to see which strategy works best.

What this could mean

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

Active substance
Methotrexate, Sulfasalazine, Leflunomide, Adalimumab
What this could lead to
If successful, this could show that starting stronger drugs earlier helps control psoriatic arthritis better than the usual step-up approach.
What could go wrong
This is a completed Phase 4 trial with 192 participants, so results are limited in size. More aggressive therapy may cause more side effects without clear benefit.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

192 people

The number who actually took part.

Started

May 2019

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Participant is willing and able to give informed consent for participation in the trial. * Male or Female, aged 18 years or above. * Participants consented to the PsA inception cohort (MONITOR-PsA) and to be approached for alternate interventional therapies. * Poor prognostic factors at baseline. Either * Polyarticular disease with ≥5 active joints at baseline assessment OR * Oligoarticular disease with \<5 active joints at baseline but with one or more of the following poor prognostic factors: raised C reactive protein, radiographic damage, health assessment questionnaire\>1 * Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter (or 2 years if received leflunomide unless treated with washout therapy) as in standard practice. * Participant has clinically acceptable laboratory results within 28 days of baseline: * Haemoglobin count \> 8.5 g/dL * White blood count (WBC) \> 3.5 x 109/L * Absolute neutrophil count (ANC) \> 1.5 x 109/L * Platelet count \> 100 x 109/L * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase levels \<3 x upper limit of normal * In the Investigator's opinion, is able and willing to comply with all trial requirements. * Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the trial. Exclusion Criteria: * Previous treatment for articular disease with DMARDs including, but not limited to, methotrexate, sulfasalazine, leflunomide and ciclosporin * Female patient who is pregnant, breast-feeding or planning pregnancy during the course of the trial. * Significant renal (estimated glomerular filtration rate \<30ml/min) or hepatic impairment. * Patients who test positive for Hepatitis B, C or HIV. * Contraindication to any of the investigative drugs. * Patients who currently abuse drugs or alcohol * Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. * Patient with life expectancy of less than 6 months. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put patients at risk because of participation in the trial, or may influence the result of the trial, or their ability to participate in the trial. * Participation in another research trial involving an investigational product in the past 12 weeks. Additional exclusion criteria apply to patients randomised to arm 3 and receiving adalimumab therapy: * Active tuberculosis (TB), chronic viral infections, recent serious bacterial infections, those receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the participant at risk. * Latent TB unless they have received appropriate anti-tuberculous treatment as per local guidelines * History of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Psoriatic arthritis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Oxford University Hospitals NHS Trust

    Oxford, Oxfordshire, OX3 7LD, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.