Study tests if starting stronger drugs earlier tames psoriatic arthritis
NCT ID NCT03739853
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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192 people
The number who actually took part.
- Started
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May 2019
- Finished
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Oct 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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
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Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LD, United Kingdom
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