Phase 1 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:

For people with Lupus (SLE):

• People aged 18 to 70 years old at the time of signing the consent form.
• People who have been diagnosed with lupus (SLE) according to recognised international classification guidelines.
• People who test positive for certain lupus-related antibodies in their blood (such as ANA, anti-dsDNA, or anti-Sm).
• People whose lupus is currently active and moderately to severely affecting them, based on a standard disease activity score.
• People whose lupus has not responded well enough to, or who could not tolerate, at least 3 different standard treatments used for at least 3 months each (such as steroids, anti-malarial drugs, or certain other immune-suppressing medications).

For people with Inflammatory Muscle Disease (IIM — Polymyositis or Dermatomyositis):

• People with a "probable" or "definite" diagnosis of polymyositis (PM) or dermatomyositis (DM) according to recognised international guidelines (not including inclusion body myositis or cancer-related muscle disease).
• People who test positive for at least one specific disease-related antibody at the screening visit.
• People whose muscle strength or skin disease scores fall within ranges indicating active disease.
• People who show signs of active muscle inflammation, either through blood tests showing elevated muscle enzymes, or through recent MRI, muscle biopsy, or nerve conduction test results.
• People who have not responded well enough to, or could not tolerate, steroids and at least 2 other standard treatments (used for at least 3 months each), where at least one of those treatments must have been a biologic medicine, intravenous immunoglobulin, or cyclophosphamide.

For people with Rheumatoid Arthritis (RA):

• People diagnosed with rheumatoid arthritis according to recognised international classification guidelines.
• People who test positive for at least one RA-related antibody (rheumatoid factor or ACPA) confirmed through the trial's central laboratory.
• People with moderate to severe disease activity, defined as having 6 or more tender joints and 6 or more swollen joints, along with a disease activity score above a certain threshold.
• People whose RA has not responded well enough to, or who could not tolerate, at least 2 different biologic or targeted treatments with different mechanisms, after having already tried conventional disease-modifying medicines (unless those conventional medicines were not suitable for them).

Who may not be able to join:

• People whose disease has caused serious, life-threatening, or organ-threatening complications that the treating doctor considers too risky for the study treatments.
• People with currently active, severe kidney disease caused by lupus.
• People who have been diagnosed with a severe form of antiphospholipid syndrome (a clotting disorder) involving arterial or certain venous clots within the past year.
• People with rapidly worsening or severe lung scarring (ILD), or lung disease that requires oxygen therapy.
• People with inclusion body myositis or muscle disease caused by cancer.
• People with active, severe, or unstable neurological or psychiatric complications of lupus.
• People with IIM whose lung function tests show significantly reduced breathing capacity or worsening lung function compared to tests done 3 or more months earlier.
• People with a significant history of serious infections, or who are considered at high risk of severe infections.
• People living with HIV.
• People with evidence of active or chronic hepatitis B infection.
• People with evidence of active or chronic hepatitis C infection.
• People with a positive COVID-19 PCR test result.
• People with a known history of a primary immune deficiency, removal of the spleen, or any condition that increases their risk of infection.
• People with significant disease affecting the brain or central nervous system.
• People who have received certain B-cell-depleting therapies (such as rituximab, ocrelizumab, ofatumumab, or obinutuzumab) within 3 months before the first day of the trial.

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