Phase 3 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children aged 2 to 17 years who have been recently diagnosed with a specific type of juvenile idiopathic arthritis (JIA) — either the type affecting a few joints (oligoarthritis) or the type affecting many joints without a certain blood marker called rheumatoid factor (RF-negative polyarthritis).
• Children who have not yet been treated with disease-modifying drugs (DMARDs), either standard or biological types — only one anti-inflammatory painkiller (NSAID) is allowed beforehand, and no steroid injections into joints before joining.
• Children whose JIA symptoms started no more than 6 months before joining the trial.
• Children who currently have active joint inflammation at the time of enrolment.
• Female participants who are old enough to become pregnant must have a negative pregnancy test at the start of the trial, and must agree to use reliable contraception throughout and have no plans to become pregnant during the study. Male participants past puberty must have no plans to father a child during the study and must agree to use reliable contraception if sexually active.
• Children (and/or their parents or guardians) who are able to follow all study procedures, communicate with the study team, and provide written consent or agreement to participate.

Who may not be able to join:

• Children whose JIA falls into one of these categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, or undifferentiated arthritis.
• Children who need whole-body (systemic) treatment for eye inflammation (uveitis).
• Children with active tuberculosis (TB), a history of TB that was not fully treated, suspected TB outside the lungs, or who have been in close contact with someone who has active or latent TB.
• Children who test positive for TB (via skin or blood test) without active disease may still be excluded unless a specialist has documented that adequate TB treatment has been completed (confirm with trial site).
• Children who have previously been treated with any standard or biological disease-modifying drug (DMARD).
• Children who have received a live vaccine (such as chickenpox, oral polio, measles, mumps, or rubella vaccines) within 4 weeks before starting the trial, or who would need one during the study.
• Children with a current or past history of cancer, or any other serious illness as assessed by their treating doctor.
• Children whose most recent blood test results show certain abnormalities, including: very low white blood cell or neutrophil counts, low haemoglobin (a measure of anaemia), platelet counts that are too low or too high, or elevated liver enzyme levels (AST or ALT) above twice the normal range.

Important: Always verify eligibility with the trial site directly before applying.